AgingNCT03799952
Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
A study testing Zoomers on the Go Exercise Program in people with Aging and Fall, run by University of New Brunswick at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- What is being tested?
- Zoomers on the Go Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Under 50 years of age
- Not cleared to perform physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Zoomers on the Go Exercise Program
- Keywords
- Older adult, Peer-led exercise program, Risk of falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoomers on the Go Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
One leg stand test (seconds)
Measured: Change pre and post (after the 12 weeks)
Walking Speed
6-minute test (meters walked)
Measured: 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.
Measured: Change pre and post (after the 12 weeks)
Strength, Arm Curl Test
Number of bicep curls with light weight
Measured: Change pre and post (after the 12 weeks)
Strength, Chair Stand Test
Chair stand test, number of chair stand in 30 seconds
Measured: Change pre and post (after the 12 weeks)
Secondary outcomes (2)
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).
Measured: Pre and post (before and after the 12 week exercise program)
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).
Measured: Pre and post (before and after the 12 week exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start7 Feb 2019
- Primary completion28 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- New Brunswick Health Research Foundation, Horizon Health Network, Universite de Moncton, Fitness New Brunswick
- Responsible party
- Principal investigator, Danielle Bouchard, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799952
- Sponsor's protocol ID
- 2019-01Zoom
- Status last verified
- Jul 2021
- First submitted
- 20 Dec 2018
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33573594
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial - Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults
- ClinicalTrials.gov ID
- NCT03799952
- Acronym / sponsor ID
- 2019-01Zoom
- Keywords
- Older adult, Peer-led exercise program, Risk of falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- New Brunswick Health Research Foundation, Horizon Health Network, Universite de Moncton, Fitness New Brunswick
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Zoomers on the Go Exercise ProgramParticipants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length. |
| Control | No intervention | –Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Under 50 years of age
- Not cleared to perform physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoomers on the Go Exercise Program60 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. | Behavioural | Intervention |
Primary outcome
Balance
Time frame: Change pre and post (after the 12 weeks)
One leg stand test (seconds)
Walking Speed
Time frame: Change pre and post (after the 12 weeks)
6-minute test (meters walked)
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.
Strength, Arm Curl Test
Time frame: Change pre and post (after the 12 weeks)
Number of bicep curls with light weight
Strength, Chair Stand Test
Time frame: Change pre and post (after the 12 weeks)
Chair stand test, number of chair stand in 30 seconds
2 secondary outcomes
Depression, Anxiety, Stress
Time frame: Pre and post (before and after the 12 week exercise program)
Perceived Quality of Life
Time frame: Pre and post (before and after the 12 week exercise program)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33573594Bouchard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoomers on the Go Exercise Program in people with Aging and Fall, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Change pre and post (after the 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.