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ReclutandoNCT07595991Registro de ClinicalTrials.gov

Post-osteoporotic Fracture Exercise Program

Osteoporosis · Osteoporotic Fracture

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
100 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
Experimental Arm for Feasibility study

Feasibility Intervention

Other: Exercise Program

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Recruitment Feasibility

Plazo: 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.

Retention Feasibility

Plazo: 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.

Exercise Class Adherence

Plazo: 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.

Medidas secundarias

Program Acceptability

Plazo: 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.

Intervention Safety

Plazo: 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.

Otras medidas

Change in Bone Quality

Plazo: 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.

Change in health care utilization

Plazo: 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.

Change in Physical Function

Plazo: 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.

Change in Functional Exercise Capacity

Plazo: 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.

Change in Mobility

Plazo: 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.

Change in Single Leg Balance

Plazo: 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.

Change in Osteoporosis-Specific Quality of Life

Plazo: 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.

Change in Overall Health-Related Quality of Life

Plazo: 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.

Change in Physical Activity

Plazo: 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.

Change in Grip Strength

Plazo: 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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Canadian Centre for Activity and AgingLondon, Ontario, CanadaReclutando
Christina Ziebart, PT, PhDCONTACTcziebart@uwo.ca519-661-2111 88850
Steve Di Ciacca, MSc, BSc(PT), BHKinCONTACTsdiciacc@uwo.ca519 661-1603 81609
Christina Ziebart, PT, PhDPRINCIPAL_INVESTIGATOR
Ver ubicación en el mapa ↗

Equipo y fechas

Patrocinador principal
Western University, Canada
Inicio del estudio
2026-12 Estimado
Finalización primaria
2027-08 Estimado
Finalización del estudio
2028-02 Estimado
Primera publicación
19 may 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Christina Ziebart, PT, PhDCONTACTcziebart@uwo.ca519-661-2111 88850
Abigail Mitchell, BScCONTACTamitc57@uwo.ca709-727-2762
Título oficial del estudio

Community Osteoporosis Exercise Class for People Post Fracture

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026