Indigenous Older Adult Health and WellbeingNCT07561008
Elders Moving Together: A Pilot Study
A study testing Exercise Program in people with Indigenous Older Adult Health and Wellbeing, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This pilot study evaluates the feasibility and acceptability of implementing the Saskatchewan Forever in Motion (FIM) group exercise program in a First Nations community in northwestern Saskatchewan. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Indigenous Older Adult Health and Wellbeing
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2023to 21 Dec 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Saulteaux First Nation Health Center
Saulteaux First Nation, Saskatchewan
About this study
This pilot study evaluates the feasibility and acceptability of implementing the Saskatchewan Forever in Motion (FIM) group exercise program in a First Nations community in northwestern Saskatchewan. The study examines changes in physical activity, social connectedness, and quality of life among older adults participating in a 12-week community-led exercise program. The project also explores access-related factors that support participation in community-based exercise programs.
Read the 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.
- Being tested
- Exercise Program
- Keywords
- Indigenous Peoples, Health Promotion, Exercise, Cultural Safety, Wellbeing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Participants will exercise twice weekly in a group exercise program led by community members at a community center on Saulteaux First Nation
| Study group | Role | What they receive |
|---|---|---|
| Participant Arm | Experimental | All participants are in this single arm of the study, where they receive 12 weeks of twice-weekly exercise programming in their community Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Program Implementation
Feasibility assessed through enrollment numbers, weekly attendance, and adherence (percentage of sessions attended per participant).
Measured: 12 weeks
Secondary outcomes (4)
Change in Physical Activity (PASE)
Self-reported physical activity measured using the Physical Activity Scale for the Elderly.
Measured: 12 weeks
Change in Quality of Life (SF-36)
Self-reported quality of life measured using the Short Form-36 questionnaire.
Measured: 12 weeks
Change in Social Connectedness (SPS-10)
Self-reported social connectedness measured using the Social Provision Scale-10.
Measured: 12 weeks
Access-Related Factors Supporting Participation
Qualitative themes from sharing circles and weekly checklists exploring what helped participants access the program.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start11 Sep 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indigenous Older Adult Health and WellbeingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saulteaux First Nation, SK
- Responsible party
- Principal investigator, Wendy Verity, University of Saskatchewan
- Investigators
- Anne Leis, PhD, Study chair, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561008
- Sponsor's protocol ID
- BIO4284
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No - data will be owned by the participating First Nations communities in accordance with Indigenous data sovereignty principles.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elders Moving Together: A Pilot Study
- ClinicalTrials.gov ID
- NCT07561008
- Acronym / sponsor ID
- BIO4284
- Keywords
- Indigenous Peoples, Health Promotion, Exercise, Cultural Safety, Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saulteaux First Nation, SK
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 1 May 2026 (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.
This pilot study evaluates the feasibility and acceptability of implementing the Saskatchewan Forever in Motion (FIM) group exercise program in a First Nations community in northwestern Saskatchewan. The study examines changes in physical activity, social connectedness, and quality of life among older adults participating in a 12-week community-led exercise program. The project also explores access-related factors that support participation in community-based exercise programs.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Arm | Experimental | Behavioral: Exercise ProgramAll participants are in this single arm of the study, where they receive 12 weeks of twice-weekly exercise programming in their community |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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+
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Exercise ProgramParticipants will exercise twice weekly in a group exercise program led by community members at a community center on Saulteaux First Nation | Behavioural | Participant Arm |
Primary outcome
Feasibility of Program Implementation
Time frame: 12 weeks
Feasibility assessed through enrollment numbers, weekly attendance, and adherence (percentage of sessions attended per participant).
4 secondary outcomes
Change in Physical Activity (PASE)
Time frame: 12 weeks
Change in Quality of Life (SF-36)
Time frame: 12 weeks
Change in Social Connectedness (SPS-10)
Time frame: 12 weeks
Access-Related Factors Supporting Participation
Time frame: 12 weeks
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 1 May 2026.
- Individual participant dataSharing planned: No. No - data will be owned by the participating First Nations communities in accordance with Indigenous data sovereignty principles.
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.
Anne Leis, PhD study chair
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Indigenous Older Adult Health and Wellbeing, run by University of Saskatchewan 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 4 inclusion and 3 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 1 May 2026. 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?
Feasibility of Program Implementation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.