AgingNCT04627493
Improving Physical Activity and Mobility Via Live Online Exercise Sessions for Older Adults
A study testing Online exercise in people with Aging, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Online exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 9 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Online exercise
- Keywords
- Exercise, Online
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online exerciseBehavioural
Participants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist (Control) | No intervention | Usual care |
| Exercise | Experimental | Online exercise program Receives: Behavioral: Online exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical activity
7 day steps and activity-related energy expenditure
Measured: Baseline, post intervention, 8-week follow-up
Secondary outcomes (7)
Change in life-space mobility score
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.
Measured: Baseline, post intervention, 8-week follow-up
Change in nutrition
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.
Measured: Baseline, post intervention, 8-week follow-up
Change in feelings of loneliness
The 11-item Revised University of California Los Angeles loneliness scale (R-UCLA) will be used to assess participants' feelings of loneliness.
Measured: Baseline, post intervention, 8-week follow-up
Change in the Geriatric Depression Scale score
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.
Measured: Baseline, post intervention, 8-week follow-up
Change in the Geriatric Anxiety Inventory score
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).
Measured: Baseline, post intervention, 8-week follow-up
Program Feasibility
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.
Measured: Throughout the participant's intervention period (0-8 weeks)
Participants experiences and perceptions
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.
Measured: 1-60 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Nov 2020
- Primary completion11 Apr 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized parallel-group trial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627493
- Sponsor's protocol ID
- 11429
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coletta G, Noguchi KS, Beaudoin KD, McQuarrie A, Tang A, Griffin M, Ganann R, Phillips SM. A live online exercise program for older adults improves depression and life-space mobility: A mixed-methods pilot randomized controlled trial. PLoS One. 2024 Nov 11;19(11):e0312992. doi: 10.1371/journal.pone.0312992. eCollection 2024.
PubMed 39527532
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity and Mobility, During a Pandemic, Via Live Online Exercise Sessions for Older Persons: a Pilot RCT
- ClinicalTrials.gov ID
- NCT04627493
- Acronym / sponsor ID
- 11429
- Conditions
- Aging
- Keywords
- Exercise, Online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a randomized parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| Waitlist (Control) | No intervention | –Usual care |
| Exercise | Experimental | Behavioral: Online exerciseOnline exercise program |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Online exerciseParticipants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week. | Behavioural | Exercise |
Primary outcome
Changes in physical activity
Time frame: Baseline, post intervention, 8-week follow-up
7 day steps and activity-related energy expenditure
7 secondary outcomes
Change in life-space mobility score
Time frame: Baseline, post intervention, 8-week follow-up
Change in nutrition
Time frame: Baseline, post intervention, 8-week follow-up
Change in feelings of loneliness
Time frame: Baseline, post intervention, 8-week follow-up
Change in the Geriatric Depression Scale score
Time frame: Baseline, post intervention, 8-week follow-up
Change in the Geriatric Anxiety Inventory score
Time frame: Baseline, post intervention, 8-week follow-up
Program Feasibility
Time frame: Throughout the participant's intervention period (0-8 weeks)
Participants experiences and perceptions
Time frame: 1-60 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39527532Coletta G, Noguchi KS, Beaudoin KD, McQuarrie A, Tang A, Griffin M, Ganann R, Phillips SM. A live online exercise program for older adults improves depression and life-space mobility: A mixed-methods pilot randomized controlled trial. PLoS One. 2024 Nov 11;19(11):e0312992. doi: 10.1371/journal.pone.0312992. eCollection 2024.
- 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.
Stuart Phillips, Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online exercise in people with Aging, run by McMaster University 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 0 inclusion and 5 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 13 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in physical activity (time frame: Baseline, post intervention, 8-week follow-up). 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 NCT04627493, 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 13 Sep 2023.