Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults

Aging Clinical Trial

Official title:

A Randomized Control Trial - Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799952
• Other study ID #: 2019-01Zoom
• Status: Completed
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2021
• Source: University of New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 30, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Aging
• Fall

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Kinesiology Building	Fredericton	New Brunswick

Sponsors (5)

Lead Sponsor	Collaborator
University of New Brunswick	Fitness New Brunswick, Horizon Health Network, New Brunswick Health Research Foundation, Universite de Moncton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Pre and post (before and after the 12 week exercise program)
Other	Connectedness, Sense of Belonging, and Friendships	All collected information via interviews with participants	Following the 12 week program
Other	The Amount of Bodily Sway When Performing Tasks and Balancing.	Measured by a portable biomechanical board. Can detect sway through sensors.	Pre and post (before and after the 12 week exercise program)
Other	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	Pre and post (before and after the 12 week exercise program)
Other	Measured on a Portable Biomechanical Board.	An individual's centre of mass as determined by sensors on a biomechanical board.	Pre and post (after the 12 weeks)
Other	Systolic Blood Pressure	Blood pressure cuff (mmHg)	Pre and post (after the 12 weeks)
Other	Resting Heart Rate	Radial pulse palpation (bpm)	Pre and post (after the 12 weeks)
Other	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	Pre and post (before and after the 12 week exercise program)
Primary	Balance	One leg stand test (seconds)	Change pre and post (after the 12 weeks)
Primary	Walking Speed	6-minute test (meters walked)	Change pre and post (after the 12 weeks)
Primary	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.	Change pre and post (after the 12 weeks)
Primary	Strength, Arm Curl Test	Number of bicep curls with light weight	Change pre and post (after the 12 weeks)
Primary	Strength, Chair Stand Test	Chair stand test, number of chair stand in 30 seconds	Change pre and post (after the 12 weeks)
Secondary	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).	Pre and post (before and after the 12 week exercise program)
Secondary	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).	Pre and post (before and after the 12 week exercise program)