Clinical trial NCT03799952: Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
Official title: A Randomized Control Trial - Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Fall
Keywords: Older adult
Peer-led exercise program
Risk of falling
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: New Brunswick Health Research Foundation
name: Horizon Health Network
name: Universite de Moncton
name: Fitness New Brunswick
First posted: 2019-01-10
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Balance
timeFrame: Change pre and post (after the 12 weeks)
measure: Walking Speed
timeFrame: Change pre and post (after the 12 weeks)
measure: Flexibility
timeFrame: Change pre and post (after the 12 weeks)
measure: Strength, Arm Curl Test
timeFrame: Change pre and post (after the 12 weeks)
measure: Strength, Chair Stand Test
timeFrame: Change pre and post (after the 12 weeks)
Secondary outcomes:
measure: Depression, Anxiety, Stress
timeFrame: Pre and post (before and after the 12 week exercise program)
measure: Perceived Quality of Life
timeFrame: Pre and post (before and after the 12 week exercise program)
Other outcomes:
measure: Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy
timeFrame: Pre and post (before and after the 12 week exercise program)
measure: Connectedness, Sense of Belonging, and Friendships
timeFrame: Following the 12 week program
measure: The Amount of Bodily Sway When Performing Tasks and Balancing.
timeFrame: Pre and post (before and after the 12 week exercise program)
measure: Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine
timeFrame: Pre and post (before and after the 12 week exercise program)
measure: Measured on a Portable Biomechanical Board.
timeFrame: Pre and post (after the 12 weeks)
measure: Systolic Blood Pressure
timeFrame: Pre and post (after the 12 weeks)
measure: Resting Heart Rate
timeFrame: Pre and post (after the 12 weeks)
measure: Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
timeFrame: Pre and post (before and after the 12 week exercise program)
Locations:
city: Fredericton
country: Canada
facility: Kinesiology Building
state: New Brunswick
Study officials:
References:
citation: Bouchard DR, Olthuis JV, Bouffard-Levasseur V, Shannon C, McDonald T, Senechal M. Peer-led exercise program for ageing adults to improve physical functions - a randomized trial. Eur Rev Aging Phys Act. 2021 Feb 11;18(1):2. doi: 10.1186/s11556-021-00257-x.