Aging, Fall
Conditions
Keywords
Older adult, Peer-led exercise program, Risk of falling
Brief summary
The objective of this study is to recruit a group of older adults and study a broad set of physical health, mental health, and social outcomes when participants exercise with an older adult, peer-led exercise program. The program to be evaluated is called Zoomers on the Go. It is a 12-week program which involves two 60-minute sessions per week and educates participants about falls, along with aerobic and resistance exercise, flexibility, and balance activities. The program is offered to older adults (age 50+) and it is delivered in their community by an older adult who is trained as a certified Zoomers group exercise leader. Participants will be recruited, then randomized so that half of them can participate in a Zoomers class in the spring (intervention group) while half will have to wait until the fall of 2019 (control group). Pre-testing for both groups will begin around March 2019. The intervention group will participate in the program for 12 weeks, then there will be post-testing following this 12-weeks for both groups. Outcomes will be compared for the intervention and control groups, to determine if there are changes in the data pre- to post-measurements that are evident solely for the intervention group.
Detailed description
This study is a randomized control trial where subjects will be randomly assigned to a control or an intervention group. Participants will be recruited through general advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These participants will be volunteers, and no compensation will be provided besides having access to a free exercise program in their community. Eligibility will be determined by the research staff prior to the baseline assessment day.Eligible participants will be evaluated at an initial day of testing at either a Horizon CommunityHealth Centre or at the University of New Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit will involve the confirmation of eligibility, reading and signing a consent form, and the administration of the measurements discussed previously. All research staff will have received the appropriate training to deliver these fitness assessments, finger pricks, and interviews. At the end of the baseline visit, research staff will randomly assign participants to the intervention or control group. The participant will wear a pedometer for seven consecutive days following this initial visit. The paper form for any information collected (e.g. consent form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access; only staff has access through a password to the lab. All information will be linked to a participant number for which the only linkable personal information (e.g., name, age, sex) will be kept in a password protected computer and only the Principal Investigator, Co-Investigators, and Research Coordinator will have access to this information. Information will be stored for a maximum of 7 years. Following this baseline assessment, participants in the intervention group will be assigned to an exercise program most convenient to them. This is a 12-week exercise program, offered twice a week. Full attendance is not mandatory for being a participant. This is a peer-led exercise program, meaning it is instructed by a leader of similar age. This leader has received extensive Fitness New Brunswick training to deliver a program aimed to reduce the risk of falls and help older adults safely increase their physical activity levels. This 60-minute exercise program involves aerobic and resistance exercise, as well as flexibility and balance activities. The program is currently designed to help individuals meet the physical activity guidelines. Participants' numbers will be used to register attendance from the leaders. Following this 12-week intervention or control period, participants will repeat all the baseline assessments (including questionnaires and interviews), with an exception that they will not have to wear the pedometer in the follow up visit. The primary objective will be to determine whether participants' experiences with the program were positive or negative, and specifically identifying participants' attributions of why/how the exercise intervention positively impacted their physical and/or mental health.
Interventions
60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.
Sponsors
Study design
Intervention model description
Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of normal activity.
Eligibility
Inclusion criteria
* 50 years of age or older * Can exercise with minimal supervision (cleared for physical activity) * Can commit to a 12-week exercise program (2 sessions/week)
Exclusion criteria
* Under 50 years of age * Not cleared to perform physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed | Change pre and post (after the 12 weeks) | 6-minute test (meters walked) |
| Strength, Arm Curl Test | Change pre and post (after the 12 weeks) | Number of bicep curls with light weight |
| Strength, Chair Stand Test | Change pre and post (after the 12 weeks) | Chair stand test, number of chair stand in 30 seconds |
| Balance | Change pre and post (after the 12 weeks) | One leg stand test (seconds) |
| Flexibility | Change pre and post (after the 12 weeks) | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of 0. If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Quality of Life | Pre and post (before and after the 12 week exercise program) | The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). |
| Depression, Anxiety, Stress | Pre and post (before and after the 12 week exercise program) | Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy | Pre and post (before and after the 12 week exercise program) | The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score |
| Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels | Pre and post (before and after the 12 week exercise program) | An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
| Connectedness, Sense of Belonging, and Friendships | Following the 12 week program | All collected information via interviews with participants |
| The Amount of Bodily Sway When Performing Tasks and Balancing. | Pre and post (before and after the 12 week exercise program) | Measured by a portable biomechanical board. Can detect sway through sensors. |
| Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Pre and post (before and after the 12 week exercise program) | Blood draw via finger prick and analyzed with a Cardiochek machine An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
| Measured on a Portable Biomechanical Board. | Pre and post (after the 12 weeks) | An individual's centre of mass as determined by sensors on a biomechanical board. |
| Systolic Blood Pressure | Pre and post (after the 12 weeks) | Blood pressure cuff (mmHg) |
| Resting Heart Rate | Pre and post (after the 12 weeks) | Radial pulse palpation (bpm) |
Countries
Canada
Participant flow
Recruitment details
Recruitment occurred between January and March 2019. Participants were recruited through radio advertisements, newspapers, posters, and social media. Per the participants availability they were allocated to the randomization or preferred arm.
Pre-assignment details
Participants were excluded if they were not cleared by the Get Active Questionnaire and did not receive clearance from their primary physician to participate
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. | 30 |
| Control Participants are instructed to continue with their daily activities and their normal physical activity levels for 12-weeks. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Program was too easy, discontinued | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 7.2 | 66.6 years STANDARD_DEVIATION 7.2 | 66.1 years STANDARD_DEVIATION 7 |
| Body Mass Index (BMI) | 27.4 kg/m^2 STANDARD_DEVIATION 4.9 | 28.9 kg/m^2 STANDARD_DEVIATION 4.5 | 25.8 kg/m^2 STANDARD_DEVIATION 4.8 |
| Household Income (>$100,000/year) | 12 Participants | 6.0 Participants | 6.0 Participants |
| Marital Status (Married) | 34 Participants | 14 Participants | 20 Participants |
| Occupation (Retired) | 33 Participants | 19 Participants | 14 Participants |
| Physical Activity Level (MVPA/week) | 58 Minutes of MVPA per week STANDARD_DEVIATION 74 | 68 Minutes of MVPA per week STANDARD_DEVIATION 68 | 48 Minutes of MVPA per week STANDARD_DEVIATION 81 |
| Physical Activity Level (Steps/day) | 6762 Steps/day STANDARD_DEVIATION 2939 | 6349 Steps/day STANDARD_DEVIATION 2903 | 7221 Steps/day STANDARD_DEVIATION 2964 |
| Race/Ethnicity, Customized | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 59 participants | 30 participants | 29 participants |
| Sex: Female, Male Female | 51 Participants | 28 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Balance
One leg stand test (seconds)
Time frame: Change pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Balance | Pre (eyes open) | 26.7 score on a scale | Standard Deviation 14.4 |
| Intervention | Balance | Post (eyes open) | 34.7 score on a scale | Standard Deviation 13.4 |
| Intervention | Balance | Pre (eyes closed) | 5.0 score on a scale | Standard Deviation 3.4 |
| Intervention | Balance | Post (eyes closed) | 5.3 score on a scale | Standard Deviation 3.5 |
| Control | Balance | Post (eyes closed) | 4.4 score on a scale | Standard Deviation 2.9 |
| Control | Balance | Pre (eyes open) | 27.9 score on a scale | Standard Deviation 16.4 |
| Control | Balance | Pre (eyes closed) | 4.9 score on a scale | Standard Deviation 3.2 |
| Control | Balance | Post (eyes open) | 29.7 score on a scale | Standard Deviation 15.6 |
Flexibility
Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of 0. If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch.
Time frame: Change pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Flexibility | Pre | -7.5 centimeters | Standard Deviation 9.9 |
| Intervention | Flexibility | Post | -5.7 centimeters | Standard Deviation 9.9 |
| Control | Flexibility | Pre | -5.2 centimeters | Standard Deviation 9.7 |
| Control | Flexibility | Post | -4.7 centimeters | Standard Deviation 9.9 |
Strength, Arm Curl Test
Number of bicep curls with light weight
Time frame: Change pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Strength, Arm Curl Test | Pre | 20.1 reps/30 seconds | Standard Deviation 5.1 |
| Intervention | Strength, Arm Curl Test | Post | 23.9 reps/30 seconds | Standard Deviation 4.9 |
| Control | Strength, Arm Curl Test | Pre | 17.3 reps/30 seconds | Standard Deviation 4.1 |
| Control | Strength, Arm Curl Test | Post | 17.4 reps/30 seconds | Standard Deviation 3.5 |
Strength, Chair Stand Test
Chair stand test, number of chair stand in 30 seconds
Time frame: Change pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Strength, Chair Stand Test | Pre | 14.1 reps/30 seconds | Standard Deviation 2.6 |
| Intervention | Strength, Chair Stand Test | Post | 17.9 reps/30 seconds | Standard Deviation 4.4 |
| Control | Strength, Chair Stand Test | Pre | 13.6 reps/30 seconds | Standard Deviation 2.7 |
| Control | Strength, Chair Stand Test | Post | 14.1 reps/30 seconds | Standard Deviation 3.5 |
Walking Speed
6-minute test (meters walked)
Time frame: Change pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Walking Speed | Pre | 476 meters | Standard Deviation 94.3 |
| Intervention | Walking Speed | Post | 539 meters | Standard Deviation 82.5 |
| Control | Walking Speed | Pre | 507 meters | Standard Deviation 90.3 |
| Control | Walking Speed | Post | 504 meters | Standard Deviation 79.7 |
Depression, Anxiety, Stress
Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995).
Time frame: Pre and post (before and after the 12 week exercise program)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Depression, Anxiety, Stress | Pre Stress (0-28) | 6.0 score on a scale | Standard Deviation 5.6 |
| Intervention | Depression, Anxiety, Stress | Post Stress (0-28) | 4.1 score on a scale | Standard Deviation 3.9 |
| Intervention | Depression, Anxiety, Stress | Pre Anxiety (0-20) | 3.5 score on a scale | Standard Deviation 3.8 |
| Intervention | Depression, Anxiety, Stress | Post Anxiety (0-20) | 3.2 score on a scale | Standard Deviation 3.3 |
| Intervention | Depression, Anxiety, Stress | Pre Depression (0-34) | 4.8 score on a scale | Standard Deviation 6.3 |
| Intervention | Depression, Anxiety, Stress | Post Depression (0-34) | 3.2 score on a scale | Standard Deviation 5.6 |
| Control | Depression, Anxiety, Stress | Pre Depression (0-34) | 3.2 score on a scale | Standard Deviation 3.8 |
| Control | Depression, Anxiety, Stress | Pre Stress (0-28) | 5.7 score on a scale | Standard Deviation 6.2 |
| Control | Depression, Anxiety, Stress | Post Anxiety (0-20) | 5.0 score on a scale | Standard Deviation 7.5 |
| Control | Depression, Anxiety, Stress | Post Stress (0-28) | 8.2 score on a scale | Standard Deviation 7.7 |
| Control | Depression, Anxiety, Stress | Post Depression (0-34) | 5.5 score on a scale | Standard Deviation 9.1 |
| Control | Depression, Anxiety, Stress | Pre Anxiety (0-20) | 2.6 score on a scale | Standard Deviation 4.7 |
Perceived Quality of Life
The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent).
Time frame: Pre and post (before and after the 12 week exercise program)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Perceived Quality of Life | Pre Physical Functioning | 78.0 score on a scale | Standard Deviation 21.2 |
| Intervention | Perceived Quality of Life | Pre Energy/Fatigue | 63.5 score on a scale | Standard Deviation 19.1 |
| Intervention | Perceived Quality of Life | Pre Pain | 73.5 score on a scale | Standard Deviation 22.3 |
| Intervention | Perceived Quality of Life | Post Energy/Fatigue | 68.7 score on a scale | Standard Deviation 16.3 |
| Intervention | Perceived Quality of Life | Pre Limitations due to Physical Health | 78.3 score on a scale | Standard Deviation 33.9 |
| Intervention | Perceived Quality of Life | Pre Social Functioning | 90.2 score on a scale | Standard Deviation 14.9 |
| Intervention | Perceived Quality of Life | Post Social Functioning | 92.1 score on a scale | Standard Deviation 13.7 |
| Intervention | Perceived Quality of Life | Post Pain | 71.9 score on a scale | Standard Deviation 20.8 |
| Intervention | Perceived Quality of Life | Pre Limitations Emotional Problems | 84.6 score on a scale | Standard Deviation 28.3 |
| Intervention | Perceived Quality of Life | Post Physical Functioning | 81.2 score on a scale | Standard Deviation 20.2 |
| Intervention | Perceived Quality of Life | Post Limitations Emotional Problems | 88.9 score on a scale | Standard Deviation 25.3 |
| Intervention | Perceived Quality of Life | Pre General Health | 71.2 score on a scale | Standard Deviation 19.1 |
| Intervention | Perceived Quality of Life | Pre Emotional Well-Being | 80.4 score on a scale | Standard Deviation 13.5 |
| Intervention | Perceived Quality of Life | Post Limitations due to Physical Health | 90.8 score on a scale | Standard Deviation 24.1 |
| Intervention | Perceived Quality of Life | Post Emotional Well-Being | 84.7 score on a scale | Standard Deviation 10.2 |
| Intervention | Perceived Quality of Life | Post General Health | 75.5 score on a scale | Standard Deviation 15.6 |
| Control | Perceived Quality of Life | Post Emotional Well-Being | 78.7 score on a scale | Standard Deviation 13.2 |
| Control | Perceived Quality of Life | Pre Physical Functioning | 80.9 score on a scale | Standard Deviation 20.1 |
| Control | Perceived Quality of Life | Post Physical Functioning | 80.4 score on a scale | Standard Deviation 18.8 |
| Control | Perceived Quality of Life | Pre Limitations due to Physical Health | 81.7 score on a scale | Standard Deviation 28.8 |
| Control | Perceived Quality of Life | Post Limitations due to Physical Health | 79.0 score on a scale | Standard Deviation 32.8 |
| Control | Perceived Quality of Life | Pre Pain | 79.1 score on a scale | Standard Deviation 17.6 |
| Control | Perceived Quality of Life | Post Pain | 71.0 score on a scale | Standard Deviation 23 |
| Control | Perceived Quality of Life | Pre General Health | 72.4 score on a scale | Standard Deviation 11.8 |
| Control | Perceived Quality of Life | Post General Health | 69.8 score on a scale | Standard Deviation 16.4 |
| Control | Perceived Quality of Life | Pre Energy/Fatigue | 67.4 score on a scale | Standard Deviation 18 |
| Control | Perceived Quality of Life | Post Energy/Fatigue | 65.4 score on a scale | Standard Deviation 17.6 |
| Control | Perceived Quality of Life | Post Social Functioning | 86.4 score on a scale | Standard Deviation 19.1 |
| Control | Perceived Quality of Life | Pre Limitations Emotional Problems | 78.8 score on a scale | Standard Deviation 33.8 |
| Control | Perceived Quality of Life | Post Limitations Emotional Problems | 84.0 score on a scale | Standard Deviation 32.1 |
| Control | Perceived Quality of Life | Pre Emotional Well-Being | 82.5 score on a scale | Standard Deviation 12.4 |
| Control | Perceived Quality of Life | Pre Social Functioning | 88.9 score on a scale | Standard Deviation 16.3 |
Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine
Blood draw via finger prick and analyzed with a Cardiochek machine An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
Time frame: Pre and post (before and after the 12 week exercise program)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Pre | 5.34 mmol/L | Standard Deviation 0.69 |
| Intervention | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Post | 4.70 mmol/L | Standard Deviation 0.52 |
| Control | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Pre | 5.61 mmol/L | Standard Deviation 1.05 |
| Control | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Post | 5.11 mmol/L | Standard Deviation 0.65 |
Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
Time frame: Pre and post (before and after the 12 week exercise program)
Connectedness, Sense of Belonging, and Friendships
All collected information via interviews with participants
Time frame: Following the 12 week program
Measured on a Portable Biomechanical Board.
An individual's centre of mass as determined by sensors on a biomechanical board.
Time frame: Pre and post (after the 12 weeks)
Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy
The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score
Time frame: Pre and post (before and after the 12 week exercise program)
Resting Heart Rate
Radial pulse palpation (bpm)
Time frame: Pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Resting Heart Rate | Pre | 68.1 beats per minute | Standard Deviation 9.4 |
| Intervention | Resting Heart Rate | Post | 63.0 beats per minute | Standard Deviation 7 |
| Control | Resting Heart Rate | Pre | 70.5 beats per minute | Standard Deviation 6.7 |
| Control | Resting Heart Rate | Post | 67.2 beats per minute | Standard Deviation 7.6 |
Systolic Blood Pressure
Blood pressure cuff (mmHg)
Time frame: Pre and post (after the 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Systolic Blood Pressure | Pre | 123.8 mmHg | Standard Deviation 12.6 |
| Intervention | Systolic Blood Pressure | Post | 125.7 mmHg | Standard Deviation 14.9 |
| Control | Systolic Blood Pressure | Pre | 127.5 mmHg | Standard Deviation 11.1 |
| Control | Systolic Blood Pressure | Post | 124.5 mmHg | Standard Deviation 9.5 |
The Amount of Bodily Sway When Performing Tasks and Balancing.
Measured by a portable biomechanical board. Can detect sway through sensors.
Time frame: Pre and post (before and after the 12 week exercise program)