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Post-osteoporotic Fracture Exercise Program

2026年8月17日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Christina Ziebart, PT, PhD
  • 电话号码：88850 519-661-2111
  • 邮箱：cziebart@uwo.ca

研究联系人备份

  • 姓名：Abigail Mitchell, BSc
  • 电话号码：709-727-2762
  • 邮箱：amitc57@uwo.ca

学习地点

  • 加拿大
    • Ontario
      • London、Ontario、加拿大、N6G 1H1
        • Canadian Centre for Activity and Aging
        • 接触：
          • Christina Ziebart, PT, PhD
          • 电话号码：88850 519-661-2111
          • 邮箱：cziebart@uwo.ca
        • 接触：
          • Steve Di Ciacca, MSc, BSc(PT), BHKin
          • 电话号码：81609 519 661-1603
          • 邮箱：sdiciacc@uwo.ca
        • 首席研究员：
          • Christina Ziebart, PT, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental Arm for Feasibility study
Feasibility Intervention
其他：Exercise Program
Participants complete a 12-week, twice weekly, whole body group exercise program. Participants will also complete qualitative interviews and DXA bone scans.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Recruitment Feasibility
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Program Acceptability
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in Bone Quality
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Western University, Canada

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 127410

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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