Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363942
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-15
Brief Title:
A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized interventional clinical trial whereby 100 participants will be randomized to either follow the SAFE exercise program experimental group or not control group At the end of the intervention the experimental group will be encouraged to continue doing the exercises and the control group will have the opportunity to participate in the SAFE exercises 12 weeks post-intervention the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not
Detailed Description:
For this study the investigators will recruit 100 frail men and women aged 75 and over from the greater Montreal area Enrolled participants will have 4 visits at their residence The first visit is a screening visit the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program The third visit will be a virtual visit by phone call and the final visit will be a post-intervention assessment of cognition and functional abilities
Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living ADLs without any changes Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes Before and after the 12-week intervention all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength functional capacities cognitive abilities and quality of life At the end of the intervention the experimental group will be encouraged to continue doing the exercises and the control group will have the opportunity to participate in the SAFE exercises 12 weeks post-intervention the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not
Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living ADLs without any changes Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes Before and after the 12-week intervention all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength functional capacities cognitive abilities and quality of life At the end of the intervention the experimental group will be encouraged to continue doing the exercises and the control group will have the opportunity to participate in the SAFE exercises 12 weeks post-intervention the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None