- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627493
Improving Physical Activity and Mobility Via Live Online Exercise Sessions for Older Adults
September 7, 2023 updated by: Stuart Phillips, McMaster University
Improving Physical Activity and Mobility, During a Pandemic, Via Live Online Exercise Sessions for Older Persons: a Pilot RCT
The COVID-19 pandemic has undoubtedly resulted in an increased level of personal anxiety, reduced access to support services, and as a secondary complication, increased physical inactivity.
Older people appear to be at higher risk of several secondary complications and long-term negative health outcomes.
These complications include declines in physical health and mobility, social isolation, and worsening mental health.
There is strong evidence in older persons that supports the role of exercise and physical activity in: the alleviation of strength and mobility declines, reducing anxiety and depression, and alleviating cognitive declines.
Exercise-based intervention trials have also been shown to reduce social isolation and loneliness.
This study will compare an online exercise program delivered via Zoom and a waitlist control group in healthy older persons.
Study Overview
Detailed Description
This study will examine the impacts of an online exercise program in healthy older persons compared to a waitlist control group.
Briefly, participants (healthy persons, age 65-80 years old) will participate in an online group exercise program (designed to meet Canada's Physical Activity Guidelines) via Zoom delivered by Registered Kinesiologists and Physiotherapists for a total of 8 weeks.
Participants will be randomly assigned to the exercise group or the waitlist control group.
Participants' will undergo assessments of physical activity, life-space mobility, nutrition, loneliness, depression, and anxiety at baseline, end of study, and 8-weeks following the end of the intervention.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- Ivor Wynne Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Exclusion Criteria:
- Experience any physical conditions which may prevent them from engaging in moderate-intensity physical activity including using assistive walking devices (e.g. cane or walker), or injuries;
- Have a history of neuromuscular conditions or muscle wasting diseases;
- Are currently participating in physical activity, ≥150 minutes of moderate-to-vigorous physical activity per week;
- Are not eligible to participate in regular physical activity according to the Canadian Society Exercise Physiology Get Active Questionnaire;
- Do not have access to the internet at home via a personal smartphone, tablet (e.g., iPad), or computer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist (Control)
Usual care
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Experimental: Exercise
Online exercise program
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Participants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in physical activity
Time Frame: Baseline, post intervention, 8-week follow-up
|
7 day steps and activity-related energy expenditure
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Baseline, post intervention, 8-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in life-space mobility score
Time Frame: Baseline, post intervention, 8-week follow-up
|
The University of Alabama Life Space Assessment, UA-LSA, will be used to assess participants life-space mobility score.
It is a global marker of older adults' physical and community mobility and it has been shown to relate to objectively-measured step counts.
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Baseline, post intervention, 8-week follow-up
|
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Change in nutrition
Time Frame: Baseline, post intervention, 8-week follow-up
|
The Screen II (Seniors in the Community Risk Evaluation for Eating and Nutrition) will be used to determine whether individuals have a potential nutritional problem or are at risk of developing one and identifies those who need further nutrition assessment and treatment.
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Baseline, post intervention, 8-week follow-up
|
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Change in feelings of loneliness
Time Frame: Baseline, post intervention, 8-week follow-up
|
The 11-item Revised University of California Los Angeles loneliness scale (R-UCLA) will be used to assess participants' feelings of loneliness.
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Baseline, post intervention, 8-week follow-up
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Change in the Geriatric Depression Scale score
Time Frame: Baseline, post intervention, 8-week follow-up
|
The Geriatric Depression Scale (GDS-15) contains 15 items that measure the intensity of depressive symptoms on a dichotomous scale (yes or no).
The total score ranges from 0 to 15.
Higher scores indicate higher levels of depressive symptoms.
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Baseline, post intervention, 8-week follow-up
|
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Change in the Geriatric Anxiety Inventory score
Time Frame: Baseline, post intervention, 8-week follow-up
|
The Geriatric Anxiety Inventory (GAI) contains 20 items that measure the intensity of anxious symptoms on a dichotomous scale (agree or disagree).
The total score ranges from 0 to 20.
A score of 10 or over is associated with the presence of a generalized anxiety disorder (GAD).
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Baseline, post intervention, 8-week follow-up
|
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Program Feasibility
Time Frame: Throughout the participant's intervention period (0-8 weeks)
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Program feasibility will be evaluated by: 1) program adherence/attendance in the online exercise program for participants in the intervention group; and 2) program satisfaction/acceptability questionnaire at the end of each online exercise class for all participants in the intervention group.
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Throughout the participant's intervention period (0-8 weeks)
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Participants experiences and perceptions
Time Frame: 1-60 days post intervention
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Participants' experiences and perceptions of exercise and our online exercise program.
This will be collected through qualitative data: semi-structured one-on-one interviews conducted with each participant who completes the online exercise program.
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1-60 days post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Phillips, Ph.D., McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
April 11, 2022
Study Completion (Actual)
May 9, 2022
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 8, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.