Physical Inactivity Clinical Trial
— HABSOfficial title:
The Healthy Aging Brain Study: A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults.
This is a twelve-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. We will test whether a four-week intergenerational social motivation using a technology-based platform (intervention group) enhances physical activity relative to a control group. After a washout period, the two groups will be offered the opportunity to cross-over into the alternate condition.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 95 Years |
Eligibility | Inclusion criteria: - Men and women > 60 years - Part of the PREVENT-AD Longitudinal Cohort at McGill - No contraindications to MRI imaging - Normal cognition - Not exercising more than 150 minutes of moderate-intensity exercise per week or sitting more than 8 hours per day - Fluency in English or French - Access to computer or smartphone with internet Exclusion criteria: - Primary care physician does not approve additional physical activity - An inability to ambulate without the assistance of another person or severe pain - Any unstable medical condition Younger Adult Inclusion Criteria: - Can be identified as child or grandchild of participant (biological or adopted), 14 years or older. - Can be a young adult (18 years or older) who is not a relative of the main participant, in case a grandchild or child is not available. - Stable on antidepressants for more than 6 months. - In contact with the primary participant more than once per 12 months at baseline - Lives anywhere accessible by mail in Canada if 18 years and older, or anywhere accessible by mail in Quebec if 14 years and older but younger than 18 years. - Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks - Able to speak, read, and write English or French - No diagnosis of a neurological disease or unstable health condition - Regular access to a computer with internet or a smartphone Study Partner exclusion criteria • Not in contact with the primary participant more than once per 12 months at baseline |
Country | Name | City | State |
---|---|---|---|
Canada | Douglas Mental Health University Institute | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Douglas Mental Health University Institute | McGill University, Montreal Neurological Institute and Hospital, National Institute on Aging (NIA) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sedentary behavior (average min/day) | This metric quantifies the change in the average amount of time spent sedentary each day, from the baseline period to the 4-week period. It is a marker of time spent inactive. | Baseline; 4-week | |
Primary | Total step count (average steps/day) | This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity. | Baseline; 4-week | |
Secondary | Moderate-vigorous activity (average min/day) | This metric quantifies the change in the average amount of time spent engaged in moderate-vigorous physical activity each day, from the baseline period to the 4-week followup period. It is a marker of physical activity. | Baseline; 4-week | |
Secondary | UCLA Loneliness Scale | A questionnaire that measures perceived level of loneliness. | Baseline; 4-week | |
Secondary | Pittsburgh Sleep Quality Index | A questionnaire measuring sleep quality. | Baseline; 4-week | |
Secondary | Modified Differential Emotions Scale | A questionnaire that assesses mood and feelings. | Baseline; 4-week | |
Secondary | Barriers to Self-Efficacy Scale | A questionnaire to assess physical activity confidence when faced with challenges (e.g., bad weather). | Baseline; 4-week | |
Secondary | Perceived Stress Scale (PSS) | This common test assesses the perception of stress. | Baseline; 4-week |
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