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NCT Number: NCT07595991

Post-osteoporotic Fracture Exercise Program

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Centre for Activity and Aging

London, Ontario, N6G 1H1, Canada

Location contact

Christina Ziebart, PT, PhD

CONTACT

[email protected]

519-661-2111 ext. 88850

Christina Ziebart, PT, PhD

PRINCIPAL_INVESTIGATOR

Steve Di Ciacca, MSc, BSc(PT), BHKin

CONTACT

[email protected]

519 661-1603 ext. 81609

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

exercise program

Other

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

Primary outcomes

  1. Recruitment Feasibility

    Time frame: Assessed over 12 months

    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.

  2. Retention Feasibility

    Time frame: Assessed at 12 weeks

    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.

  3. Exercise Class Adherence

    Time frame: Assessed over the 12-week intervention period

    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.

Secondary outcomes

  1. Program Acceptability

    Time frame: Assessed at 12 weeks

    Program acceptability will be assessed using participant exit interviews conducted at the completion of the intervention. Acceptability will be calculated as the percentage of participants who report a positive response regarding satisfaction with the program. The predefined acceptability target is 80%. Percentages range from 0% to 100%, with higher percentages indicating greater program acceptability.

  2. Intervention Safety

    Time frame: Assessed throughout the 12-week intervention period

    Intervention safety will be assessed by recording the number and type of adverse events attributable to the intervention, including falls, musculoskeletal pain, prolonged muscle soreness, dizziness, fainting, shortness of breath, and other participant-reported medical concerns. Lower numbers indicate better intervention safety.

Other outcomes

  1. Change in Bone Quality

    Time frame: Baseline and 12 weeks

    Bone quality will be assessed using dual-energy X-ray absorptiometry (DXA), including Trabecular Bone Score assessment of bone microarchitecture. Higher bone mineral density and Trabecular Bone Score values indicate better bone health and bone microarchitecture.

  2. Change in health care utilization

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

    Health care utilization will be assessed using Institute for Clinical Evaluative Sciences (ICES) health administrative records. Measures of health care utilization may include health care visits, hospitalizations, and fracture-related health service use following participation in the exercise program. Lower health care utilization and fewer fracture-related events may indicate improved health outcomes.

  3. Change in Physical Function

    Time frame: Baseline, 6 weeks, and 12 weeks

    Physical function will be assessed using the Short Physical Performance Battery. Scores range from 0 to 12, with higher scores indicating better lower extremity physical function.

  4. Change in Functional Exercise Capacity

    Time frame: Baseline, 6 weeks, and 12 weeks

    Functional exercise capacity will be assessed using the 6-Minute Walk Test. Distance will be measured in meters, with greater distances indicating better functional exercise capacity.

  5. Change in Mobility

    Time frame: Baseline, 6 weeks, and 12 weeks

    Mobility will be assessed using the Timed Up and Go Test. Time will be measured in seconds, with lower times indicating better mobility and lower fall risk.

  6. Change in Single Leg Balance

    Time frame: Baseline, 6 weeks, and 12 weeks

    Static balance will be assessed using the Single Leg Balance Test. Time will be measured in seconds, with longer durations indicating better balance performance.

  7. Change in Osteoporosis-Specific Quality of Life

    Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

    Quality of life will be assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Scores range from 0 to 100, with lower scores indicating better quality of life.

  8. Change in Overall Health-Related Quality of Life

    Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

    Health-related quality of life will be assessed using the EuroQol 5 Dimension (EQ-5D). Scores range from less than 0 to 1, with higher scores indicating better health-related quality of life.

  9. Change in Physical Activity

    Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

    Physical activity participation will be assessed using the Physical Activity Scale for the Elderly. Scores range from 0 to over 400, with higher scores indicating greater physical activity participation.

  10. Change in Grip Strength

    Time frame: Baseline, 6 weeks, and 12 weeks

    Grip strength will be assessed using hand dynamometry. Grip strength will be measured in kilograms, with higher values indicating greater grip strength and upper extremity muscle function.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Mitchell, BSc

CONTACT

[email protected]

709-727-2762

Christina Ziebart, PT, PhD

CONTACT

[email protected]

519-661-2111 ext. 88850

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Community Osteoporosis Exercise Class for People Post Fracture

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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