Arthritis, Cancer, Cardiovascular Diseases, Chronic Disease, Chronic Lung Disease, Congestive Heart Failure, Diabetes Mellitus, Frail, Hypertension, Kidney Diseases, Osteoporosis, Osteopenia, Stroke
Conditions
Keywords
Strength Training, Balance Training, Nutrition Education, Older adults, Frailty, Feasibility
Brief summary
There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.
Detailed description
The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.
Interventions
OTHERStrength and Balance Training & Nutrition Education
Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.
OTHERUsual Care
During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.
Sponsors
Canadian Institutes of Health Research (CIHR)
City of Lakes family Health Team
Schlegel-UW Research Institute for Aging
YMCA
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Single (Outcomes Assessor)
Intervention model description
We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Speak English or attend with a translator; * ≥ 60 years; * FRAIL scale score ≥1; * Have ≥1 diagnosed chronic condition (i.e., diabetes, obesity, cancer (other than minor skin cancer), chronic lung disease, cardiovascular disease, congestive heart failure, hypertension, osteoporosis, arthritis, stroke, or kidney disease).
Exclusion criteria
* Currently doing similar resistance exercise ≥2x/week; * In palliative care; * Not able to perform basic activities of daily living; * Cognitive impairment (e.g., unable to follow two-step commands); * Travelling \>1 week during exposure; * Absolute exercise contraindications (i.e., if they select no to any question in the Get Active Questionnaire they must seek physician approval before exercising)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment | 2 month (September to October 2019) | Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites. |
| Feasibility - Retention | Start of the program to 9 weeks | Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end. |
| Feasibility - Adherence | 16 sessions | Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Second Chair Stand Test | Mean change from follow up (study visit 4) and baseline | We will use a chair with a straight back without arm rests (seat 17 high), and a stopwatch. This will assess leg strength and endurance. |
| 4 Square Step Test | Mean change from follow up (study visit 4) and baseline | The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls |
| EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | Mean change from follow up (study visit 4) and baseline | The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better. |
| Body Weight | Baseline | We will measure body weight with a calibrated scale. |
| Number of Participants With Adverse Events | Study visit 1, 2, 3 and 4 | We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section |
| Participant and Provider Experience | study visit 4 | We used a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section. |
| Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | Mean change from follow up (study visit 4) and baseline | We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section |
| 10 Meter Walk Test | Mean change from follow up (study visit 4) and baseline | Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. |
| Grip Strength | Mean change from follow up (study visit 4) and baseline | Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer |
Countries
Canada
Participant flow
Recruitment details
Within one-week of randomization but prior to the start of the intervention, five individuals dropped out.
Participants by arm
| Arm | Count |
|---|---|
| Intervention At regular intervals (the steps) one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.
Strength and Balance Training & Nutrition Education: Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical Arbour Trails (n = 9) <=18 years | 0 Participants |
| Age, Categorical Arbour Trails (n = 9) >=65 years | 8 Participants |
| Age, Categorical Arbour Trails (n = 9) Between 18 and 65 years | 1 Participants |
| Age, Categorical Kinnect to Wellness (n = 15) <=18 years | 0 Participants |
| Age, Categorical Kinnect to Wellness (n = 15) >=65 years | 15 Participants |
| Age, Categorical Kinnect to Wellness (n = 15) Between 18 and 65 years | 0 Participants |
| Age, Categorical Village of Winston Park (n = 9) <=18 years | 0 Participants |
| Age, Categorical Village of Winston Park (n = 9) >=65 years | 9 Participants |
| Age, Categorical Village of Winston Park (n = 9) Between 18 and 65 years | 0 Participants |
| Age, Categorical YMCA (n = 11) <=18 years | 0 Participants |
| Age, Categorical YMCA (n = 11) >=65 years | 10 Participants |
| Age, Categorical YMCA (n = 11) Between 18 and 65 years | 1 Participants |
| Age, Continuous Arbour Trails | 78 years |
| Age, Continuous Kinnect to Wellness | 81 years |
| Age, Continuous Village of Winston Park | 84 years |
| Age, Continuous YMCA | 72 years |
| Ethnicity (NIH/OMB) Arbour Trail Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Arbour Trail Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Arbour Trail Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Kinnect to Wellness Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Kinnect to Wellness Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Kinnect to Wellness Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Village of Winston Park Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Village of Winston Park Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Village of Winston Park Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) YMCA Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) YMCA Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) YMCA Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Arbour Trails Female | 7 Participants |
| Sex: Female, Male Arbour Trails Male | 2 Participants |
| Sex: Female, Male Kinnect to Wellness Female | 10 Participants |
| Sex: Female, Male Kinnect to Wellness Male | 5 Participants |
| Sex: Female, Male Village of Winston Park Female | 7 Participants |
| Sex: Female, Male Village of Winston Park Male | 2 Participants |
| Sex: Female, Male YMCA Female | 10 Participants |
| Sex: Female, Male YMCA Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 44 | 3 / 44 |
| serious Total, serious adverse events | 1 / 44 | 2 / 44 |
Outcome results
Primary
Feasibility - Adherence
Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.
Time frame: 16 sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arbour Trails | Feasibility - Adherence | 73 % of exercise sessions completed |
| City of Lakes Family Health Team | Feasibility - Adherence | 66 % of exercise sessions completed |
| Village of Winston Park | Feasibility - Adherence | 73 % of exercise sessions completed |
| YMCA's | Feasibility - Adherence | 77 % of exercise sessions completed |
Primary
Feasibility - Recruitment
Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.
Time frame: 2 month (September to October 2019)
Population: Five individuals withdrew a few days after randomization, and, since the program had not started, we recruited an additional four participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arbour Trails | Feasibility - Recruitment | 9 # of participants @ start of study |
| City of Lakes Family Health Team | Feasibility - Recruitment | 15 # of participants @ start of study |
| Village of Winston Park | Feasibility - Recruitment | 9 # of participants @ start of study |
| YMCA's | Feasibility - Recruitment | 11 # of participants @ start of study |
Primary
Feasibility - Retention
Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.
Time frame: Start of the program to 9 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arbour Trails | Feasibility - Retention | 6 # of participants that completed study |
| City of Lakes Family Health Team | Feasibility - Retention | 8 # of participants that completed study |
| Village of Winston Park | Feasibility - Retention | 8 # of participants that completed study |
| YMCA's | Feasibility - Retention | 9 # of participants that completed study |
Secondary
10 Meter Walk Test
Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.
Time frame: Mean change from follow up (study visit 4) and baseline
Population: 10-meter walk test protocol. (m/s)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | 10 Meter Walk Test | 0.08 Change in gait speed (meters/second) | Standard Deviation 0.17 |
| City of Lakes Family Health Team | 10 Meter Walk Test | 0.16 Change in gait speed (meters/second) | Standard Deviation 0.24 |
| Village of Winston Park | 10 Meter Walk Test | 0.31 Change in gait speed (meters/second) | Standard Deviation 0.36 |
| YMCA's | 10 Meter Walk Test | 0.16 Change in gait speed (meters/second) | Standard Deviation 0.23 |
Secondary
30 Second Chair Stand Test
We will use a chair with a straight back without arm rests (seat 17 high), and a stopwatch. This will assess leg strength and endurance.
Time frame: Mean change from follow up (study visit 4) and baseline
Population: Number of chair stands within 30 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | 30 Second Chair Stand Test | 1.33 Change number of sit to stands | Standard Deviation 2.69 |
| City of Lakes Family Health Team | 30 Second Chair Stand Test | 2.44 Change number of sit to stands | Standard Deviation 2.53 |
| Village of Winston Park | 30 Second Chair Stand Test | 2.04 Change number of sit to stands | Standard Deviation 2.45 |
| YMCA's | 30 Second Chair Stand Test | 0.64 Change number of sit to stands | Standard Deviation 9.29 |
Secondary
4 Square Step Test
The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls
Time frame: Mean change from follow up (study visit 4) and baseline
Population: The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | 4 Square Step Test | -5.14 seconds | Standard Deviation 6.48 |
| City of Lakes Family Health Team | 4 Square Step Test | 6.54 seconds | Standard Deviation 6.15 |
| Village of Winston Park | 4 Square Step Test | 5.39 seconds | Standard Deviation 6.54 |
| YMCA's | 4 Square Step Test | -1.86 seconds | Standard Deviation 3.03 |
Secondary
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section
Time frame: Mean change from follow up (study visit 4) and baseline
Population: For protein intake at baseline, we only collected baseline measures for 40 individuals. Specific site data is not available
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arbour Trails | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | 69.46 protein in grams/day |
| City of Lakes Family Health Team | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | 70.88 protein in grams/day |
Comparison: To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).p-value: 0.0595% CI: [-4.44, 7.73]GEE
Secondary
Body Weight
We will measure body weight with a calibrated scale.
Time frame: Baseline
Population: We used a standard scale to weight each participant in Kg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | Body Weight | 63.96 Baseline body weight in Kg | Standard Deviation 12.27 |
| City of Lakes Family Health Team | Body Weight | 77.09 Baseline body weight in Kg | Standard Deviation 10.39 |
| Village of Winston Park | Body Weight | 64.76 Baseline body weight in Kg | Standard Deviation 7.63 |
| YMCA's | Body Weight | 66.66 Baseline body weight in Kg | Standard Deviation 12.8 |
Secondary
EuroQol 5 Dimension Version 5-level (EQ-5D-5L)
The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better.
Time frame: Mean change from follow up (study visit 4) and baseline
Population: Higher score is better
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | 0.04 change in score on a scale | Standard Deviation 0.08 |
| City of Lakes Family Health Team | EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | 0.06 change in score on a scale | Standard Deviation 0.08 |
| Village of Winston Park | EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | 0.25 change in score on a scale | Standard Deviation 0.33 |
| YMCA's | EuroQol 5 Dimension Version 5-level (EQ-5D-5L) | 0.06 change in score on a scale | Standard Deviation 0.07 |
Secondary
Grip Strength
Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer
Time frame: Mean change from follow up (study visit 4) and baseline
Population: Grip strength in Kg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arbour Trails | Grip Strength | 0.17 Change in Grip Strength (Kg) | Standard Deviation 4.31 |
| City of Lakes Family Health Team | Grip Strength | -1.57 Change in Grip Strength (Kg) | Standard Deviation 6.24 |
| Village of Winston Park | Grip Strength | 0.89 Change in Grip Strength (Kg) | Standard Deviation 0.33 |
| YMCA's | Grip Strength | 0.86 Change in Grip Strength (Kg) | Standard Deviation 6.26 |
Secondary
Number of Participants With Adverse Events
We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section
Time frame: Study visit 1, 2, 3 and 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arbour Trails | Number of Participants With Adverse Events | 1 participants |
| City of Lakes Family Health Team | Number of Participants With Adverse Events | 1 participants |
| Village of Winston Park | Number of Participants With Adverse Events | 2 participants |
| YMCA's | Number of Participants With Adverse Events | 0 participants |
Secondary
Participant and Provider Experience
We used a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section.
Time frame: study visit 4