- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07561008
Elders Moving Together: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Saskatchewan Forever in Motion (FIM) program is an evidence-based group exercise program for older adults that includes walking, gentle resistance band exercises, balance training, and stretching. The program is delivered by trained community members and aims to reduce barriers to physical activity such as cost, transportation, and cultural insensitivity.
This pilot study will implement the FIM program on Saulteaux First Nation, Saskatchewan, Canada. Twenty adults aged 50+ will be recruited. Participants will attend twice-weekly group exercise sessions for 12 weeks. Data collection includes baseline and post-program surveys assessing physical activity (PASE), quality of life (SF-36), and social connectedness (SPS-10), as well as attendance tracking and qualitative sharing circles exploring access-related factors.
Quantitative data will be analyzed for pre-post changes, and qualitative data will undergo inductive thematic analysis. Findings will inform future implementation of culturally safe exercise programs in Indigenous communities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saulteaux First Nation, Saskatchewan, Canada
- Saulteaux First Nation Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 50+
- Band member or resident of Saulteaux First Nation
- Able to participate in low-intensity exercise
- Adults under 50 may attend, but priority is given to those 50+
Exclusion Criteria:
- Uncontrolled cardiovascular, metabolic, pulmonary, or renal conditions as identified by the CSEP PAR-Q+
- Determined unable to safely participate in group exercise even with support
- Unable to provide informed consent and no appropriate substitute decision-maker available
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant Arm
All participants are in this single arm of the study, where they receive 12 weeks of twice-weekly exercise programming in their community
|
Participants will exercise twice weekly in a group exercise program led by community members at a community center on Saulteaux First Nation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Program Implementation
Time Frame: 12 weeks
|
Feasibility assessed through enrollment numbers, weekly attendance, and adherence (percentage of sessions attended per participant).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Activity (PASE)
Time Frame: 12 weeks
|
Self-reported physical activity measured using the Physical Activity Scale for the Elderly.
|
12 weeks
|
|
Change in Quality of Life (SF-36)
Time Frame: 12 weeks
|
Self-reported quality of life measured using the Short Form-36 questionnaire.
|
12 weeks
|
|
Change in Social Connectedness (SPS-10)
Time Frame: 12 weeks
|
Self-reported social connectedness measured using the Social Provision Scale-10.
|
12 weeks
|
|
Access-Related Factors Supporting Participation
Time Frame: 12 weeks
|
Qualitative themes from sharing circles and weekly checklists exploring what helped participants access the program.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anne Leis, PhD, University of Saskatchewan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- BIO4284
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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