A Home-based Multicomponent Exercise Intervention Program Based on the Fogg Behavior Model (FBM) for Older Adults With Osteosarcopenia and Frailty
Construction and Application of a Home-based Multicomponent Exercise Intervention Program for Older Adults With Osteosarcopenia Complicated by Frailty Based on the Fogg Behavior Model（FBM）
This study aims to construct and evaluate a home-based multicomponent exercise intervention program based on the Fogg Behavior Model for older adults with osteosarcopenia and frailty. Eligible participants will be randomly divided into two groups. The intervention group will receive the home multicomponent exercise guidance built on Fogg Behavior Model, while the control group will get routine health education. We will compare frailty status, muscle strength, physical function,bone mineral density and quality of life between the two groups at baseline, 3 months and 6 months, to explore whether this intervention can improve physical function and reduce frailty in elderly patients with osteosarcopenia.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Li Sun, Master' degree
- 電話番号：8615896264283
- メール：sunliborntowin@126.com
研究場所
-
-
Jiangsu
-
Nantong、Jiangsu、中国、226000
- 募集
- Nantong First People's Hospital
-
コンタクト：
- Yan Hai Gu, Bachelor's degree
- 電話番号：8613862938568
- メール：guhaiyan.2009@163.com
-
Nantong、Jiangsu、中国、226001
- 募集
- Nantong First People's Hospital
-
コンタクト：
- Li Sun, Master' degree
- 電話番号：8615896264283
- メール：sunliborntowin@126.com
-
副調査官：
- Yan Hai Gu, Bachelor
-
副調査官：
- Qian Zhi Gong, Master
-
副調査官：
- Hua Guan Xu, Doctor
-
主任研究者：
- Yu Yu Sun, Doctor
-
副調査官：
- Qin Xuan, Bachelor
-
副調査官：
- Yan Dong Zhu, Master
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- The disease is in stable condition.
- Aged 60-85 years or older.
- Meet the diagnostic criteria in the 2022 Expert Consensus on Sarcopenia-Osteoporosis.
- The score of frailty scale is ≥1, indicating patients are in pre-frailty or frailty status.
- Clear consciousness, normal communication, capable of cooperating with exercise intervention; not living alone and will not leave the residence within half a year.
- Own a smartphone and voluntarily participate in this study.
Exclusion Criteria:
- Severe cardiopulmonary, hepatic or renal dysfunction.
- Uncontrolled severe neurological or psychiatric diseases.
- Recent fracture or unable to perform exercise training.
- Malignant tumor, severe infectious disease.
- Participate in other exercise intervention studies simultaneously.
- Cognitive impairment and cannot cooperate with follow-up.
研究計画
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention group
Home-based multi-component exercise intervention guided by Fogg Behavior Model, including resistance training, balance training and aerobic exercise for 6 months. Regular follow-up and behavior reminder will be provided. |
Participants receive a 6-month multi-component home-based exercise intervention based on the Fogg Behavior Model, divided into 3 stages. Stage 1 (Weeks 1-2): motivation cultivation, health assessment, risk screening and health education. Stage 2 (Weeks 3-12): personalized exercise prescription including warm-up, aerobic, resistance, balance and flexibility training, with progressive intensity and regular follow-up. Stage 3 (Months 4-6): habit formation, self-management reinforcement and incentive strategies. The intervention aims to improve muscle mass, physical function and frailty status in older adults with sarcopenia-osteoporosis. |
|
アクティブコンパレータ：Control group
Routine health education about osteoporosis and sarcopenia. No systematic supervised exercise intervention. |
Participants receive routine osteoporosis health education and standard nursing care. General advice on diet, fall prevention and daily activity is provided, without the multi-component staged exercise intervention based on the Fogg Behavior Model. Regular outpatient follow-up is arranged. |
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 |
|---|---|---|
|
Change in frailty phenotype score at 6 months
時間枠：Baseline, 3 months, 6 months
|
The change of Fried frailty phenotype score from baseline to 6-month follow-up. Fried frailty scale ranges from 0 to 5, higher score means worse frailty status. |
Baseline, 3 months, 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in handgrip strength at 6 months
時間枠：Baseline, 3 months,6 months
|
The change of handgrip strength (kg) from baseline to 6-month follow-up |
Baseline, 3 months,6 months
|
|
Change in Short Physical Performance Battery (SPPB) score at 6 months
時間枠：Baseline,3 months, 6 months
|
The change of SPPB score from baseline to 6-month follow-up. SPPB ranges from 0 to 12, higher score indicates better physical performance. |
Baseline,3 months, 6 months
|
|
Change in skeletal muscle mass index (SMI) at 6 months
時間枠：Baseline,3 months, 6 months
|
The change of skeletal muscle mass index (kg/m²) from baseline to 6-month follow-up, assessed by bioelectrical impedance analysis. |
Baseline,3 months, 6 months
|
|
Change in bone mineral density (BMD) at 6 months
時間枠：Baseline,6 months
|
The change of lumbar spine bone mineral density (g/cm²) from baseline to 6-month follow-up, measured by dual-energy X-ray absorptiometry (DXA). |
Baseline,6 months
|
|
Change in quality of life at 6 months
時間枠：Baseline,3 months, 6 months
|
The change of quality of life measured by the 12-item Short Form Health Survey (SF-12) from baseline to 6-month follow-up. |
Baseline,3 months, 6 months
|
|
Incidence of falls within 6 months
時間枠：6 months
|
The number of participants who experienced fall events during the 6-month intervention period. |
6 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 2025LY056
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?
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米国FDA規制医薬品の研究
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