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.
調査の概要
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Christina Ziebart, PT, PhD
- 電話番号：88850 519-661-2111
- メール：cziebart@uwo.ca
研究連絡先のバックアップ
- 名前：Abigail Mitchell, BSc
- 電話番号：709-727-2762
- メール：amitc57@uwo.ca
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6G 1H1
- Canadian Centre for Activity and Aging
-
コンタクト：
- Christina Ziebart, PT, PhD
- 電話番号：88850 519-661-2111
- メール：cziebart@uwo.ca
-
コンタクト：
- Steve Di Ciacca, MSc, BSc(PT), BHKin
- 電話番号：81609 519 661-1603
- メール：sdiciacc@uwo.ca
-
主任研究者：
- Christina Ziebart, PT, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental Arm for Feasibility study
Feasibility Intervention
|
Participants complete a 12-week, twice weekly, whole body group exercise program.
Participants will also complete qualitative interviews and DXA bone scans.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Feasibility
時間枠：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.
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Assessed over 12 months
|
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Retention Feasibility
時間枠：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.
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Assessed at 12 weeks
|
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Exercise Class Adherence
時間枠：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.
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Assessed over the 12-week intervention period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Program Acceptability
時間枠：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.
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Assessed at 12 weeks
|
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Intervention Safety
時間枠：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.
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Assessed throughout the 12-week intervention period
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Bone Quality
時間枠：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.
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Baseline and 12 weeks
|
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Change in health care utilization
時間枠：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.
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Assessed over the 6-month period following completion of the exercise program
|
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Change in Physical Function
時間枠：Baseline, 6 weeks, and 12 weeks
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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.
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Baseline, 6 weeks, and 12 weeks
|
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Change in Functional Exercise Capacity
時間枠：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.
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Baseline, 6 weeks, and 12 weeks
|
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Change in Mobility
時間枠：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.
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Baseline, 6 weeks, and 12 weeks
|
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Change in Single Leg Balance
時間枠：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.
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Baseline, 6 weeks, and 12 weeks
|
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Change in Osteoporosis-Specific Quality of Life
時間枠：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.
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Baseline, 6 weeks, 12 weeks, and 6 months
|
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Change in Overall Health-Related Quality of Life
時間枠：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.
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Baseline, 6 weeks, 12 weeks, and 6 months
|
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Change in Physical Activity
時間枠：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.
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Baseline, 6 weeks, 12 weeks, and 6 months
|
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Change in Grip Strength
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年8月1日
研究の完了 (推定)
2028年2月1日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月20日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 127410
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
Sharing of individual participant data will be upon request and only deidentified data will be shared
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いいえ
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