NCT03799952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

December 20, 2018

Results QC Date

December 1, 2020

Last Update Submit

July 13, 2021

Conditions

Keywords

Older adultPeer-led exercise programRisk of falling

Outcome Measures

Primary Outcomes (5)

  • Balance

    One leg stand test (seconds)

    Change pre and post (after the 12 weeks)

  • Walking Speed

    6-minute test (meters walked)

    Change pre and post (after the 12 weeks)

  • 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)

  • Strength, Arm Curl Test

    Number of bicep curls with light weight

    Change pre and post (after the 12 weeks)

  • Strength, Chair Stand Test

    Chair stand test, number of chair stand in 30 seconds

    Change pre and post (after the 12 weeks)

Secondary Outcomes (2)

  • Depression, Anxiety, Stress

    Pre and post (before and after the 12 week exercise program)

  • Perceived Quality of Life

    Pre and post (before and after the 12 week exercise program)

Other Outcomes (8)

  • 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)

  • Connectedness, Sense of Belonging, and Friendships

    Following the 12 week program

  • The Amount of Bodily Sway When Performing Tasks and Balancing.

    Pre and post (before and after the 12 week exercise program)

  • +5 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.

Behavioral: Zoomers on the Go Exercise Program

Control

NO INTERVENTION

Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks.

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.

Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Under 50 years of age
  • Not cleared to perform physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinesiology Building

Fredericton, New Brunswick, E3B 5A3, Canada

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Danielle Bouchard
Organization
University of New Brunswick

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 10, 2019

Study Start

February 7, 2019

Primary Completion

November 28, 2019

Study Completion

November 30, 2019

Last Updated

July 14, 2021

Results First Posted

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations