Osteoporotic Fractures, Spinal Fractures
Conditions
Keywords
Osteoporosis, Spine fracture, Vertebral fracture, Exercise Interventions, Exercise
Brief summary
The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
Detailed description
There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre randomized controlled trial (RCT) to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise studies among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.
Interventions
BEHAVIORALExercise and behaviour change strategies
1. cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day 2. postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) 3. perform muscle strengthening and balance training exercises ≥ 3 days a week 4. the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
University Health Network, Toronto
McMaster University
University of Melbourne
University of British Columbia
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following: * documented height loss of ≥2cm * historical height loss of ≥6cm * visible hyperkyphosis * age greater than or equal to 65 years of age * able to understand instructions in english * able to give informed consent (no cognitive impairment)
Exclusion criteria
* Current or prior cancer * On dialysis, known liver, kidney or malabsorption disease * Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care. * Current participation in muscle strengthening or similar exercise program ≥ 3 times per week * Uncontrolled hypertension or other contraindications to exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment and Retention | Monthly records up to 12 months. | Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained. |
| Adherence | Monthly records over 12 months | Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Fallers | Monthly up to one year. | Diary for participants to self-report falls. |
| Occiput to Wall Distance | Baseline and one year. | — |
| Scores on the Short Physical Performance Battery (SPPB) | Baseline and one year. | The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance. |
| Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Baseline and one year. | Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance. |
| Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Baseline, 6 months and one year. | OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain. |
| Scores on Exercise Self-efficacy Scales. | Baseline, 6 months and one year. | To assess self-efficacy related to engaging in exercise, participants will be asked Over the next 3 months, how confident are you that you can perform exercise on most days of the week? and Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?. To assess implementation intentions, participants are asked Do you already have concrete plans regarding exercise?. Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy. |
| Productivity | Monthly up to one year. | Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work. |
| Physical Activity | Baseline, 6 months, 12 months | A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days. |
| Number of Serious Adverse Events. | Monthly up to one year. | Defined as death or event that is life-threatening, requires hospitalization or results in disability. |
| Number of Individuals Screened and Eligible Per Collection Site. | over the course of the study (2.29 years) | Number of participants randomized out of all participants screened |
| Score on Short-form Falls Efficacy Scale International (FES-I). | Baseline, 6 months and one year. | Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling. |
| Number of Participants With Multiple Falls | Monthly up to 12 months. | — |
| Total Number of Falls | Monthly up to 12 months. | — |
| Value of Direct Medical Resources Per Participant. | Accrued costs over 12 months | — |
| Value of Non-direct Medical Resources Per Participant. | Accrued costs over 12 months | — |
| Participant Height | Baseline and one year | — |
| Activities of Daily Living | Monthly up to one year | 0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty. |
| Timed Loaded Standing Test | Baseline and one year | A physical performance measure of combined trunk and arm endurance. |
| Location of Vertebral Fractures | Baseline and Month 12 | Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5. |
| Participant Weight | Baseline and Month 12 | — |
| Number of Potentially Eligible Males | over recruitment period | — |
| Number of Fractures. | Baseline, one year and at report of fracture (monitored monthly for reports). | Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise and Behaviour Change Strategies The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day. | 71 |
| General Health or Social Discussion Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. | 70 |
| Total | 141 |
Baseline characteristics
| Characteristic | Exercise and Behaviour Change Strategies | General Health or Social Discussion | Total |
|---|---|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 6.4 | 77 years STANDARD_DEVIATION 7.28 | 76 years STANDARD_DEVIATION 6.85 |
| Sex: Female, Male Female | 71 Participants | 70 Participants | 141 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 70 |
| other Total, other adverse events | 43 / 71 | 34 / 70 |
| serious Total, serious adverse events | 17 / 71 | 12 / 70 |
Outcome results
Primary
Adherence
Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
Time frame: Monthly records over 12 months
Population: Only the Exercise Group received the exercise program.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Adherence | 66 % of weeks meeting adherence threshold |
Primary
Feasibility of Recruitment and Retention
Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Time frame: Monthly records up to 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Feasibility of Recruitment and Retention | 66 Participants |
| General Health or Social Discussion | Feasibility of Recruitment and Retention | 64 Participants |
Secondary
Activities of Daily Living
0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
Time frame: Monthly up to one year
Population: Subsequent number of participants drops after baseline due to withdrawals or monthly follow-up not being completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 2 | 2.99 units on a scale | Standard Deviation 2.841 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 7 | 2.95 units on a scale | Standard Deviation 2.772 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 4 | 3.14 units on a scale | Standard Deviation 2.762 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 8 | 2.98 units on a scale | Standard Deviation 2.723 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 1 | 2.79 units on a scale | Standard Deviation 2.696 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 9 | 2.98 units on a scale | Standard Deviation 2.831 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 5 | 3.45 units on a scale | Standard Deviation 2.922 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 10 | 2.97 units on a scale | Standard Deviation 2.414 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 3 | 2.96 units on a scale | Standard Deviation 2.946 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 11 | 2.90 units on a scale | Standard Deviation 2.537 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 6 | 2.74 units on a scale | Standard Deviation 2.613 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Month 12 | 2.52 units on a scale | Standard Deviation 2.599 |
| Exercise and Behaviour Change Strategies | Activities of Daily Living | Baseline | 3.17 units on a scale | Standard Deviation 3.005 |
| General Health or Social Discussion | Activities of Daily Living | Month 12 | 2.58 units on a scale | Standard Deviation 2.342 |
| General Health or Social Discussion | Activities of Daily Living | Baseline | 3.46 units on a scale | Standard Deviation 2.406 |
| General Health or Social Discussion | Activities of Daily Living | Month 1 | 2.75 units on a scale | Standard Deviation 2.397 |
| General Health or Social Discussion | Activities of Daily Living | Month 2 | 3.05 units on a scale | Standard Deviation 2.446 |
| General Health or Social Discussion | Activities of Daily Living | Month 3 | 3.12 units on a scale | Standard Deviation 2.362 |
| General Health or Social Discussion | Activities of Daily Living | Month 4 | 3.34 units on a scale | Standard Deviation 2.639 |
| General Health or Social Discussion | Activities of Daily Living | Month 5 | 3.39 units on a scale | Standard Deviation 2.741 |
| General Health or Social Discussion | Activities of Daily Living | Month 6 | 2.95 units on a scale | Standard Deviation 2.673 |
| General Health or Social Discussion | Activities of Daily Living | Month 7 | 3.33 units on a scale | Standard Deviation 2.691 |
| General Health or Social Discussion | Activities of Daily Living | Month 8 | 3.07 units on a scale | Standard Deviation 2.389 |
| General Health or Social Discussion | Activities of Daily Living | Month 9 | 3.28 units on a scale | Standard Deviation 2.821 |
| General Health or Social Discussion | Activities of Daily Living | Month 10 | 3.14 units on a scale | Standard Deviation 2.599 |
| General Health or Social Discussion | Activities of Daily Living | Month 11 | 3.32 units on a scale | Standard Deviation 2.381 |
Comparison: Month 12 scores.p-value: 0.995% CI: [-0.917, 0.807]t-test, 2 sided
Secondary
Location of Vertebral Fractures
Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.
Time frame: Baseline and Month 12
Population: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (9 intervention, 8 control) did not have a second x-ray.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Baseline T1-T3 | 3 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Baseline T4-T8 | 54 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Baseline T9-L1 | 74 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Baseline L2-L5 | 38 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Month 12 T1-T3 | 3 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Month 12 T4-T8 | 43 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Month 12 T9-L1 | 66 Fractures |
| Exercise and Behaviour Change Strategies | Location of Vertebral Fractures | Month 12 L2-L5 | 34 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Month 12 L2-L5 | 28 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Baseline T1-T3 | 1 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Month 12 T1-T3 | 2 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Baseline T4-T8 | 42 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Month 12 T9-L1 | 76 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Baseline T9-L1 | 88 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Month 12 T4-T8 | 39 Fractures |
| General Health or Social Discussion | Location of Vertebral Fractures | Baseline L2-L5 | 36 Fractures |
Secondary
Number of Fallers
Diary for participants to self-report falls.
Time frame: Monthly up to one year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Fallers | 48 Participants |
| General Health or Social Discussion | Number of Fallers | 36 Participants |
95% CI: [0.99, 1.74]
Secondary
Number of Fractures.
Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.
Time frame: Baseline, one year and at report of fracture (monitored monthly for reports).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Fractures. | Baseline | 168 Fractures |
| Exercise and Behaviour Change Strategies | Number of Fractures. | 12 Month Follow-up | 183 Fractures |
| General Health or Social Discussion | Number of Fractures. | Baseline | 163 Fractures |
| General Health or Social Discussion | Number of Fractures. | 12 Month Follow-up | 178 Fractures |
95% CI: [0.58, 1.94]
Secondary
Number of Individuals Screened and Eligible Per Collection Site.
Number of participants randomized out of all participants screened
Time frame: over the course of the study (2.29 years)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Individuals Screened and Eligible Per Collection Site. | 141 Participants |
Secondary
Number of Participants With Multiple Falls
Time frame: Monthly up to 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Participants With Multiple Falls | 31 Participants |
| General Health or Social Discussion | Number of Participants With Multiple Falls | 22 Participants |
Secondary
Number of Potentially Eligible Males
Time frame: over recruitment period
Population: Total people screened for inclusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Potentially Eligible Males | 308 Participants |
Secondary
Number of Serious Adverse Events.
Defined as death or event that is life-threatening, requires hospitalization or results in disability.
Time frame: Monthly up to one year.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Number of Serious Adverse Events. | 18 events |
| General Health or Social Discussion | Number of Serious Adverse Events. | 12 events |
Secondary
Occiput to Wall Distance
Time frame: Baseline and one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Occiput to Wall Distance | Month 12 | 5.3 centimetres | Standard Deviation 4.4 |
| Exercise and Behaviour Change Strategies | Occiput to Wall Distance | Baseline | 5.3 centimetres | Standard Deviation 4 |
| General Health or Social Discussion | Occiput to Wall Distance | Baseline | 6.2 centimetres | Standard Deviation 4.7 |
| General Health or Social Discussion | Occiput to Wall Distance | Month 12 | 6.1 centimetres | Standard Deviation 3.9 |
Comparison: Baselinep-value: 0.81195% CI: [-0.84, 1.07]t-test, 2 sided
Comparison: Month 12p-value: 0.76595% CI: [-0.8, 1.09]t-test, 2 sided
Secondary
Participant Height
Time frame: Baseline and one year
Population: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (5 intervention, 2 control) did not attend the follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Participant Height | Baseline | 156.5 centimetres | Standard Deviation 6.4 |
| Exercise and Behaviour Change Strategies | Participant Height | Month 12 | 156.4 centimetres | Standard Deviation 6.6 |
| General Health or Social Discussion | Participant Height | Baseline | 156.1 centimetres | Standard Deviation 7.2 |
| General Health or Social Discussion | Participant Height | Month 12 | 155.9 centimetres | Standard Deviation 7.2 |
Comparison: Comparison of change from baseline in heightp-value: 0.53695% CI: [-0.28, 0.53]t-test, 2 sided
Secondary
Participant Weight
Time frame: Baseline and Month 12
Population: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (7 intervention, 2 control) either did not attend the follow-up visit or did not have access to a scale at the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Participant Weight | Baseline | 65.1 kilograms | Standard Deviation 12.8 |
| Exercise and Behaviour Change Strategies | Participant Weight | Month 12 | 66.1 kilograms | Standard Deviation 13.3 |
| General Health or Social Discussion | Participant Weight | Baseline | 66.5 kilograms | Standard Deviation 15.4 |
| General Health or Social Discussion | Participant Weight | Month 12 | 66.6 kilograms | Standard Deviation 15.4 |
Comparison: Comparison of change from baseline in weightp-value: 0.46195% CI: [-0.25, 0.55]t-test, 2 sided
Secondary
Physical Activity
A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.
Time frame: Baseline, 6 months, 12 months
Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5) Withdrawals at 12 months - intervention group (n=5) and control group (n=6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Physical Activity | Baseline Walking | 168.8 Minutes per week | Standard Deviation 366 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 6 Walking | 165.4 Minutes per week | Standard Deviation 120.6 |
| Exercise and Behaviour Change Strategies | Physical Activity | Baseline Moderate-Vigorous physical activity | 43.2 Minutes per week | Standard Deviation 138.5 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 12 Strength/Balance physical activity | 68.4 Minutes per week | Standard Deviation 68.3 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 6 Strength/Balance physical activity | 80.8 Minutes per week | Standard Deviation 85.8 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 12 Moderate-Vigorous physical activity | 93.9 Minutes per week | Standard Deviation 225.9 |
| Exercise and Behaviour Change Strategies | Physical Activity | Baseline Strength/Balance physical activity | 6.7 Minutes per week | Standard Deviation 17 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 12 Walking | 161.2 Minutes per week | Standard Deviation 140.7 |
| Exercise and Behaviour Change Strategies | Physical Activity | Month 6 Moderate-Vigorous physical activity | 76.1 Minutes per week | Standard Deviation 143.9 |
| General Health or Social Discussion | Physical Activity | Month 12 Walking | 268.0 Minutes per week | Standard Deviation 342.3 |
| General Health or Social Discussion | Physical Activity | Baseline Moderate-Vigorous physical activity | 48.8 Minutes per week | Standard Deviation 156.1 |
| General Health or Social Discussion | Physical Activity | Baseline Walking | 194.9 Minutes per week | Standard Deviation 278.3 |
| General Health or Social Discussion | Physical Activity | Month 6 Strength/Balance physical activity | 15.7 Minutes per week | Standard Deviation 36.4 |
| General Health or Social Discussion | Physical Activity | Month 6 Moderate-Vigorous physical activity | 147.3 Minutes per week | Standard Deviation 346 |
| General Health or Social Discussion | Physical Activity | Month 6 Walking | 154.0 Minutes per week | Standard Deviation 161.6 |
| General Health or Social Discussion | Physical Activity | Month 12 Strength/Balance physical activity | 21.1 Minutes per week | Standard Deviation 44.9 |
| General Health or Social Discussion | Physical Activity | Month 12 Moderate-Vigorous physical activity | 128.9 Minutes per week | Standard Deviation 352.3 |
| General Health or Social Discussion | Physical Activity | Baseline Strength/Balance physical activity | 6.4 Minutes per week | Standard Deviation 16.8 |
Comparison: Only Month 6 and Month 12 strength and balance physical activity differences were significant.p-value: <0.0595% CI: [-91.8, -40]t-test, 2 sided
Comparison: Only Month 6 and Month 12 strength and balance physical activity differences were significant.p-value: <0.0595% CI: [-69.8, -28.8]t-test, 2 sided
Secondary
Productivity
Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.
Time frame: Monthly up to one year.
Population: Only participants who reported working and/or volunteering were asked this question.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Productivity | Month 3 | 1.21 units on a scale | Standard Deviation 2.149 |
| Exercise and Behaviour Change Strategies | Productivity | Month 5 | 0.11 units on a scale | Standard Deviation 0.471 |
| Exercise and Behaviour Change Strategies | Productivity | Month 7 | .80 units on a scale | Standard Deviation 1.781 |
| Exercise and Behaviour Change Strategies | Productivity | Month 6 | 0.69 units on a scale | Standard Deviation 1.778 |
| Exercise and Behaviour Change Strategies | Productivity | Month 8 | 0.93 units on a scale | Standard Deviation 2.056 |
| Exercise and Behaviour Change Strategies | Productivity | Month 1 | 1.60 units on a scale | Standard Deviation 2.257 |
| Exercise and Behaviour Change Strategies | Productivity | Month 9 | 1.07 units on a scale | Standard Deviation 2.556 |
| Exercise and Behaviour Change Strategies | Productivity | Month 10 | 0.95 units on a scale | Standard Deviation 2.089 |
| Exercise and Behaviour Change Strategies | Productivity | Month 4 | 1.00 units on a scale | Standard Deviation 1.91 |
| Exercise and Behaviour Change Strategies | Productivity | Month 11 | 0.88 units on a scale | Standard Deviation 2.029 |
| Exercise and Behaviour Change Strategies | Productivity | Month 2 | 1.32 units on a scale | Standard Deviation 2.212 |
| Exercise and Behaviour Change Strategies | Productivity | Month 12 | 0.76 units on a scale | Standard Deviation 2.022 |
| Exercise and Behaviour Change Strategies | Productivity | Baseline | 1.89 units on a scale | Standard Deviation 2.536 |
| General Health or Social Discussion | Productivity | Month 12 | 2.16 units on a scale | Standard Deviation 2.115 |
| General Health or Social Discussion | Productivity | Baseline | 1.85 units on a scale | Standard Deviation 1.927 |
| General Health or Social Discussion | Productivity | Month 2 | 2.12 units on a scale | Standard Deviation 1.965 |
| General Health or Social Discussion | Productivity | Month 3 | 2.94 units on a scale | Standard Deviation 2.947 |
| General Health or Social Discussion | Productivity | Month 5 | 1.57 units on a scale | Standard Deviation 1.91 |
| General Health or Social Discussion | Productivity | Month 6 | 1.88 units on a scale | Standard Deviation 2.261 |
| General Health or Social Discussion | Productivity | Month 1 | 1.76 units on a scale | Standard Deviation 1.985 |
| General Health or Social Discussion | Productivity | Month 4 | 2.50 units on a scale | Standard Deviation 2.307 |
| General Health or Social Discussion | Productivity | Month 7 | 2.07 units on a scale | Standard Deviation 2.556 |
| General Health or Social Discussion | Productivity | Month 8 | 2.00 units on a scale | Standard Deviation 2.191 |
| General Health or Social Discussion | Productivity | Month 9 | 1.76 units on a scale | Standard Deviation 2.333 |
| General Health or Social Discussion | Productivity | Month 10 | 1.24 units on a scale | Standard Deviation 1.855 |
| General Health or Social Discussion | Productivity | Month 11 | 1.83 units on a scale | Standard Deviation 2.503 |
Comparison: Baselinep-value: 0.95195% CI: [-1.412, 1.501]t-test, 2 sided
Comparison: Month 12p-value: 0.03995% CI: [-2.721, -0.071]t-test, 2 sided
Secondary
Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS).
OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.
Time frame: Baseline, 6 months and one year.
Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Month 6 | 5.4 score on a scale | Standard Deviation 1.2 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Month 12 | 3.6 score on a scale | Standard Deviation 2.7 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Baseline | 2.7 score on a scale | Standard Deviation 2.7 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Month 12 | 1.9 score on a scale | Standard Deviation 2.2 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Month 6 | 75.5 score on a scale | Standard Deviation 17.6 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Baseline | 3.8 score on a scale | Standard Deviation 2.9 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Month 6 | 2.3 score on a scale | Standard Deviation 2.4 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Month 12 | 5.4 score on a scale | Standard Deviation 1.4 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Month 12 | 74.6 score on a scale | Standard Deviation 19.1 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Month 6 | 3.0 score on a scale | Standard Deviation 2.4 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Baseline | 5.1 score on a scale | Standard Deviation 1.3 |
| Exercise and Behaviour Change Strategies | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Baseline | 74.1 score on a scale | Standard Deviation 19.1 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Baseline | 5.2 score on a scale | Standard Deviation 1.2 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Baseline | 75.7 score on a scale | Standard Deviation 20 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Month 6 | 5.6 score on a scale | Standard Deviation 1.2 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | OQLQ - Average - Month 12 | 5.4 score on a scale | Standard Deviation 1.3 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Baseline | 2.4 score on a scale | Standard Deviation 2.1 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Month 6 | 2.1 score on a scale | Standard Deviation 2.1 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Month 6 | 3.5 score on a scale | Standard Deviation 2.5 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Month 12 | 3.9 score on a scale | Standard Deviation 2.5 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS at Rest - Month 12 | 2.1 score on a scale | Standard Deviation 2.2 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | Pain VAS Movement - Baseline | 4.2 score on a scale | Standard Deviation 2.6 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Month 6 | 75.7 score on a scale | Standard Deviation 18.8 |
| General Health or Social Discussion | Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). | EQ5D-VAS - Month 12 | 75.7 score on a scale | Standard Deviation 15.4 |
Comparison: Comparison of change from baseline in EQ5D - VASp-value: 0.85495% CI: [-5.66, 6.83]t-test, 2 sided
Comparison: Comparison of change from baseline in EQ5D-VASp-value: 0.58595% CI: [-4.66, 8.22]t-test, 2 sided
Comparison: Comparison of change from baseline in OQLQ Average Scorep-value: 0.33595% CI: [-0.16, 0.47]t-test, 2 sided
Comparison: Comparison of change from baseline in OQLQ Average Scorep-value: 0.28595% CI: [-0.15, 0.5]t-test, 2 sided
Comparison: Comparison of change from baseline in pain VAS at restp-value: 0.22595% CI: [-1.36, 0.32]t-test, 2 sided
Comparison: Comparison of change from baseline in pain VAS at restp-value: 0.48895% CI: [-1.16, 0.56]t-test, 2 sided
Comparison: Comparison of change from baseline in pain VAS during movementp-value: 0.80895% CI: [-0.68, 0.88]t-test, 2 sided
Comparison: Comparison of change from baseline in pain VAS during movementp-value: 0.56695% CI: [-0.57, 1.04]t-test, 2 sided
Secondary
Score on Short-form Falls Efficacy Scale International (FES-I).
Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.
Time frame: Baseline, 6 months and one year.
Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Score on Short-form Falls Efficacy Scale International (FES-I). | Baseline | 12.1 score on a scale | Standard Deviation 4.8 |
| Exercise and Behaviour Change Strategies | Score on Short-form Falls Efficacy Scale International (FES-I). | Month 6 | 11.4 score on a scale | Standard Deviation 4 |
| Exercise and Behaviour Change Strategies | Score on Short-form Falls Efficacy Scale International (FES-I). | Month 12 | 11.5 score on a scale | Standard Deviation 4.7 |
| General Health or Social Discussion | Score on Short-form Falls Efficacy Scale International (FES-I). | Month 12 | 12.3 score on a scale | Standard Deviation 5 |
| General Health or Social Discussion | Score on Short-form Falls Efficacy Scale International (FES-I). | Baseline | 12.9 score on a scale | Standard Deviation 5.6 |
| General Health or Social Discussion | Score on Short-form Falls Efficacy Scale International (FES-I). | Month 6 | 11.5 score on a scale | Standard Deviation 4.7 |
Secondary
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.
Time frame: Baseline and one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Baseline | 13.5 score on a scale | Standard Deviation 2.2 |
| Exercise and Behaviour Change Strategies | Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Month 12 | 13.6 score on a scale | Standard Deviation 2.6 |
| General Health or Social Discussion | Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Baseline | 13.2 score on a scale | Standard Deviation 2 |
| General Health or Social Discussion | Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). | Month 12 | 13.2 score on a scale | Standard Deviation 2.3 |
Comparison: Baselinep-value: 0.71995% CI: [-0.54, 0.78]t-test, 2 sided
Comparison: Month 12p-value: 0.74595% CI: [-0.56, 0.79]t-test, 2 sided
Secondary
Scores on Exercise Self-efficacy Scales.
To assess self-efficacy related to engaging in exercise, participants will be asked Over the next 3 months, how confident are you that you can perform exercise on most days of the week? and Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?. To assess implementation intentions, participants are asked Do you already have concrete plans regarding exercise?. Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy.
Time frame: Baseline, 6 months and one year.
Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Scores on Exercise Self-efficacy Scales. | Baseline | 4.4 units on a scale | Standard Deviation 0.7 |
| Exercise and Behaviour Change Strategies | Scores on Exercise Self-efficacy Scales. | Month 6 | 4.2 units on a scale | Standard Deviation 0.7 |
| Exercise and Behaviour Change Strategies | Scores on Exercise Self-efficacy Scales. | Month 12 | 4.0 units on a scale | Standard Deviation 0.8 |
| General Health or Social Discussion | Scores on Exercise Self-efficacy Scales. | Baseline | 4.4 units on a scale | Standard Deviation 0.6 |
| General Health or Social Discussion | Scores on Exercise Self-efficacy Scales. | Month 6 | 4.0 units on a scale | Standard Deviation 0.8 |
| General Health or Social Discussion | Scores on Exercise Self-efficacy Scales. | Month 12 | 4.0 units on a scale | Standard Deviation 0.7 |
Secondary
Scores on the Short Physical Performance Battery (SPPB)
The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.
Time frame: Baseline and one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Scores on the Short Physical Performance Battery (SPPB) | Baseline | 9.6 score on a scale | Standard Deviation 2.2 |
| Exercise and Behaviour Change Strategies | Scores on the Short Physical Performance Battery (SPPB) | 12 months | 9.7 score on a scale | Standard Deviation 2.5 |
| General Health or Social Discussion | Scores on the Short Physical Performance Battery (SPPB) | Baseline | 8.8 score on a scale | Standard Deviation 2.3 |
| General Health or Social Discussion | Scores on the Short Physical Performance Battery (SPPB) | 12 months | 9.0 score on a scale | Standard Deviation 2.3 |
Comparison: Baselinep-value: 0.79695% CI: [-0.8, 0.61]t-test, 2 sided
Comparison: Month 12p-value: 0.88895% CI: [-0.75, 0.65]t-test, 2 sided
Secondary
Timed Loaded Standing Test
A physical performance measure of combined trunk and arm endurance.
Time frame: Baseline and one year
Population: Only participants from the University of Waterloo and the University of Toronto sites assessed.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Timed Loaded Standing Test | Month 12 | 120 Seconds | Standard Deviation 39.9 |
| Exercise and Behaviour Change Strategies | Timed Loaded Standing Test | Baseline | 101.9 Seconds | Standard Deviation 39.8 |
| General Health or Social Discussion | Timed Loaded Standing Test | Baseline | 107.5 Seconds | Standard Deviation 34.6 |
| General Health or Social Discussion | Timed Loaded Standing Test | Month 12 | 106 Seconds | Standard Deviation 37.6 |
Comparison: Baselinep-value: 0.71295% CI: [-33.6, 23.2]t-test, 2 sided
Comparison: Month 12p-value: 0.695% CI: [-23.3, 39.5]t-test, 1 sided
Secondary
Total Number of Falls
Time frame: Monthly up to 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise and Behaviour Change Strategies | Total Number of Falls | 130 Falls |
| General Health or Social Discussion | Total Number of Falls | 127 Falls |
Comparison: Negative Binomial Regression.95% CI: [0.58, 1.63]
Secondary
Value of Direct Medical Resources Per Participant.
Time frame: Accrued costs over 12 months
Population: For each resource cost, only participants utilizing the resource are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Value of Direct Medical Resources Per Participant. | Medications | 2127 Dollars (Canadian) | Standard Deviation 3579 |
| Exercise and Behaviour Change Strategies | Value of Direct Medical Resources Per Participant. | Medical costs related to adverse events | 1680 Dollars (Canadian) | Standard Deviation 3600 |
| Exercise and Behaviour Change Strategies | Value of Direct Medical Resources Per Participant. | Physician visits and tests/ procedures | 829 Dollars (Canadian) | Standard Deviation 1033 |
| Exercise and Behaviour Change Strategies | Value of Direct Medical Resources Per Participant. | Allied health professional visits | 301 Dollars (Canadian) | Standard Deviation 331 |
| General Health or Social Discussion | Value of Direct Medical Resources Per Participant. | Allied health professional visits | 95 Dollars (Canadian) | Standard Deviation 51 |
| General Health or Social Discussion | Value of Direct Medical Resources Per Participant. | Medications | 1823 Dollars (Canadian) | Standard Deviation 3063 |
| General Health or Social Discussion | Value of Direct Medical Resources Per Participant. | Physician visits and tests/ procedures | 848 Dollars (Canadian) | Standard Deviation 863 |
| General Health or Social Discussion | Value of Direct Medical Resources Per Participant. | Medical costs related to adverse events | 3130 Dollars (Canadian) | Standard Deviation 3180 |
Secondary
Value of Non-direct Medical Resources Per Participant.
Time frame: Accrued costs over 12 months
Population: For each resource cost, only participants utilizing the resource are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise and Behaviour Change Strategies | Value of Non-direct Medical Resources Per Participant. | Unpaid caregiver time | 5005 Dollars (Canadian) | Standard Deviation 9220 |
| Exercise and Behaviour Change Strategies | Value of Non-direct Medical Resources Per Participant. | Lost productivity | 998 Dollars (Canadian) | Standard Deviation 1642 |
| Exercise and Behaviour Change Strategies | Value of Non-direct Medical Resources Per Participant. | Out of pocket costs | 1007 Dollars (Canadian) | Standard Deviation 1453 |
| General Health or Social Discussion | Value of Non-direct Medical Resources Per Participant. | Unpaid caregiver time | 4631 Dollars (Canadian) | Standard Deviation 8091 |
| General Health or Social Discussion | Value of Non-direct Medical Resources Per Participant. | Lost productivity | 917 Dollars (Canadian) | Standard Deviation 1322 |
| General Health or Social Discussion | Value of Non-direct Medical Resources Per Participant. | Out of pocket costs | 872 Dollars (Canadian) | Standard Deviation 1250 |