NCT07561008

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Indigenous PeoplesHealth PromotionExerciseCultural SafetyWellbeing

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Program Implementation

    Feasibility assessed through enrollment numbers, weekly attendance, and adherence (percentage of sessions attended per participant).

    12 weeks

Secondary Outcomes (4)

  • Change in Physical Activity (PASE)

    12 weeks

  • Change in Quality of Life (SF-36)

    12 weeks

  • Change in Social Connectedness (SPS-10)

    12 weeks

  • Access-Related Factors Supporting Participation

    12 weeks

Study Arms (1)

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

Behavioral: Exercise Program

Interventions

Participants will exercise twice weekly in a group exercise program led by community members at a community center on Saulteaux First Nation

Participant Arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saulteaux First Nation Health Center

Saulteaux First Nation, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anne Leis, PhD

    University of Saskatchewan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

September 11, 2023

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No - data will be owned by the participating First Nations communities in accordance with Indigenous data sovereignty principles.

Locations