Improving Physical Activity and Mobility Via Live Online Exercise Sessions for Older Adults

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Improving Physical Activity and Mobility, During a Pandemic, Via Live Online Exercise Sessions for Older Persons: a Pilot RCT

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Behavioral: Online exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomized parallel-group trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist (Control)<br>Usual care | |
| Experimental: Exercise<br>Online exercise program | Behavioral: Online exercise<br>* Participants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physical activity | 7 day steps and activity-related energy expenditure | Baseline, post intervention, 8-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 1-60 days post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Online