NCT07595991

Brief Summary

Those with osteoporosis often have weaker bones and this leads to higher chances of fractures. Therefore, the investigators want to evaluate the feasibility and safety of group exercise classes specifically designed for individuals with osteoporosis who had an osteoporotic fracture. By focusing on this high-risk population, the investigators want to see whether such exercise interventions can be an option for improving bone health, reducing the risk of future fractures, and enhancing physical function without compromising safety.

Trial Health

63
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Feb 2028

First Submitted

Initial submission to the registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

April 28, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

OsteoporosisExercise InterventionOsteoporotic fracture

Outcome Measures

Primary Outcomes (3)

  • Recruitment Feasibility

    Recruitment feasibility will be assessed by the number of participants enrolled in the study over a 12-month recruitment period. The target recruitment goal is 100 participants.

    Assessed over 12 months

  • Retention Feasibility

    Retention feasibility will be assessed as the percentage of enrolled participants who complete the 12-week reassessment. The predefined retention target is 60%. Percentages range from 0% to 100%, with higher percentages indicating better retention feasibility.

    Assessed at 12 weeks

  • Exercise Class Adherence

    Exercise adherence will be assessed using class attendance records. Adherence will be calculated as the percentage of scheduled exercise sessions attended by each participant. The predefined adherence target is 80%. Percentages range from 0% to 100%, with higher percentages indicating better adherence.

    Assessed over the 12-week intervention period

Secondary Outcomes (2)

  • Program Acceptability

    Assessed at 12 weeks

  • Intervention Safety

    Assessed throughout the 12-week intervention period

Other Outcomes (10)

  • Change in Bone Quality

    Baseline and 12 weeks

  • Change in health care utilization

    Assessed over the 6-month period following completion of the exercise program

  • Change in Physical Function

    Baseline, 6 weeks, and 12 weeks

  • +7 more other outcomes

Study Arms (1)

Experimental Arm for Feasibility study

EXPERIMENTAL

Feasibility Intervention

Other: Exercise Program

Interventions

Participants complete a 12-week, twice weekly, whole body group exercise program. Participants will also complete qualitative interviews and DXA bone scans.

Experimental Arm for Feasibility study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with osteoporosis.
  • History of low trauma fracture within the past year
  • Cleared for physical activity using the get active questionnaire, 100 bpm resting heart rate or less, 160 mm Hg diastolic blood pressure or less
  • Able to understand and provide informed consent.
  • Residing within the study's geographic area (e.g., London, Ontario).

You may not qualify if:

  • Individuals who do not understand the English language
  • Medical conditions contraindicating participation in exercise (e.g., uncontrolled cardiovascular disease, severe respiratory illness).
  • Cognitive impairments that prevent informed consent or participation.
  • Recent major surgeries or medical events limiting physical activity.
  • Participation in conflicting clinical trials or rehabilitation programs.
  • Residents outside the designated study area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Centre for Activity and Aging

London, Ontario, N6G 1H1, Canada

Location

MeSH Terms

Conditions

OsteoporosisOsteoporotic Fractures

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Christina Ziebart, PT, PhD

CONTACT

Abigail Mitchell, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations