- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03799952
Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
A Randomized Control Trial - Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
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Fredericton, New Brunswick, Canada, E3B 5A3
- Kinesiology Building
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
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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.
|
No Intervention: Control
Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Change pre and post (after the 12 weeks)
|
One leg stand test (seconds)
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Change pre and post (after the 12 weeks)
|
Walking Speed
Time Frame: Change pre and post (after the 12 weeks)
|
6-minute test (meters walked)
|
Change pre and post (after the 12 weeks)
|
Flexibility
Time Frame: 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.
|
Change pre and post (after the 12 weeks)
|
Strength, Arm Curl Test
Time Frame: Change pre and post (after the 12 weeks)
|
Number of bicep curls with light weight
|
Change pre and post (after the 12 weeks)
|
Strength, Chair Stand Test
Time Frame: Change pre and post (after the 12 weeks)
|
Chair stand test, number of chair stand in 30 seconds
|
Change pre and post (after the 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety, Stress
Time Frame: 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).
|
Pre and post (before and after the 12 week exercise program)
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Perceived Quality of Life
Time Frame: Pre and post (before and after the 12 week exercise program)
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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).
|
Pre and post (before and after the 12 week exercise program)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy
Time Frame: Pre and post (before and after the 12 week exercise program)
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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
|
Pre and post (before and after the 12 week exercise program)
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Connectedness, Sense of Belonging, and Friendships
Time Frame: Following the 12 week program
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All collected information via interviews with participants
|
Following the 12 week program
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The Amount of Bodily Sway When Performing Tasks and Balancing.
Time Frame: Pre and post (before and after the 12 week exercise program)
|
Measured by a portable biomechanical board.
Can detect sway through sensors.
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Pre and post (before and after the 12 week exercise program)
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Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine
Time Frame: Pre and post (before and after the 12 week exercise program)
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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 |
Pre and post (before and after the 12 week exercise program)
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Measured on a Portable Biomechanical Board.
Time Frame: Pre and post (after the 12 weeks)
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An individual's centre of mass as determined by sensors on a biomechanical board.
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Pre and post (after the 12 weeks)
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Systolic Blood Pressure
Time Frame: Pre and post (after the 12 weeks)
|
Blood pressure cuff (mmHg)
|
Pre and post (after the 12 weeks)
|
Resting Heart Rate
Time Frame: Pre and post (after the 12 weeks)
|
Radial pulse palpation (bpm)
|
Pre and post (after the 12 weeks)
|
Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
Time Frame: Pre and post (before and after the 12 week exercise program)
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An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
|
Pre and post (before and after the 12 week exercise program)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-01Zoom
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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