Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Post-osteoporotic Fracture Exercise Program

17 augusti 2026 uppdaterad av: Christina Ziebart, Western University, Canada

Community Osteoporosis Exercise Class for People Post Fracture

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Christina Ziebart, PT, PhD
  • Telefonnummer: 88850 519-661-2111
  • E-post: cziebart@uwo.ca

Studera Kontakt Backup

  • Namn: Abigail Mitchell, BSc
  • Telefonnummer: 709-727-2762
  • E-post: amitc57@uwo.ca

Studieorter

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6G 1H1
        • Canadian Centre for Activity and Aging
        • Kontakt:
          • Christina Ziebart, PT, PhD
          • Telefonnummer: 88850 519-661-2111
          • E-post: cziebart@uwo.ca
        • Kontakt:
          • Steve Di Ciacca, MSc, BSc(PT), BHKin
          • Telefonnummer: 81609 519 661-1603
          • E-post: sdiciacc@uwo.ca
        • Huvudutredare:
          • Christina Ziebart, PT, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experimental Arm for Feasibility study
Feasibility Intervention
Övrig: Exercise Program
Participants complete a 12-week, twice weekly, whole body group exercise program. Participants will also complete qualitative interviews and DXA bone scans.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment Feasibility
Tidsram: 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.
Assessed over 12 months
Retention Feasibility
Tidsram: 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.
Assessed at 12 weeks
Exercise Class Adherence
Tidsram: 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.
Assessed over the 12-week intervention period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Program Acceptability
Tidsram: 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.
Assessed at 12 weeks
Intervention Safety
Tidsram: 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.
Assessed throughout the 12-week intervention period

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Bone Quality
Tidsram: 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.
Baseline and 12 weeks
Change in health care utilization
Tidsram: 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.
Assessed over the 6-month period following completion of the exercise program
Change in Physical Function
Tidsram: 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.
Baseline, 6 weeks, and 12 weeks
Change in Functional Exercise Capacity
Tidsram: 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.
Baseline, 6 weeks, and 12 weeks
Change in Mobility
Tidsram: 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.
Baseline, 6 weeks, and 12 weeks
Change in Single Leg Balance
Tidsram: 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.
Baseline, 6 weeks, and 12 weeks
Change in Osteoporosis-Specific Quality of Life
Tidsram: 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.
Baseline, 6 weeks, 12 weeks, and 6 months
Change in Overall Health-Related Quality of Life
Tidsram: 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.
Baseline, 6 weeks, 12 weeks, and 6 months
Change in Physical Activity
Tidsram: 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.
Baseline, 6 weeks, 12 weeks, and 6 months
Change in Grip Strength
Tidsram: 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.
Baseline, 6 weeks, and 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Western University, Canada

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 februari 2028

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 127410

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Sharing of individual participant data will be upon request and only deidentified data will be shared

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera