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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Li Sun, Master' degree
- Numero di telefono: 8615896264283
- Email: sunliborntowin@126.com
Luoghi di studio
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Jiangsu
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Nantong, Jiangsu, Cina, 226000
- Reclutamento
- Nantong First People's Hospital
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Contatto:
- Yan Hai Gu, Bachelor's degree
- Numero di telefono: 8613862938568
- Email: guhaiyan.2009@163.com
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Nantong, Jiangsu, Cina, 226001
- Reclutamento
- Nantong First People's Hospital
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Contatto:
- Li Sun, Master' degree
- Numero di telefono: 8615896264283
- Email: sunliborntowin@126.com
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Sub-investigatore:
- Yan Hai Gu, Bachelor
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Sub-investigatore:
- Qian Zhi Gong, Master
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Sub-investigatore:
- Hua Guan Xu, Doctor
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Investigatore principale:
- Yu Yu Sun, Doctor
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Sub-investigatore:
- Qin Xuan, Bachelor
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Sub-investigatore:
- Yan Dong Zhu, Master
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
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Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in frailty phenotype score at 6 months
Lasso di tempo: Baseline, 3 months, 6 months
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in handgrip strength at 6 months
Lasso di tempo: Baseline, 3 months,6 months
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The change of handgrip strength (kg) from baseline to 6-month follow-up |
Baseline, 3 months,6 months
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Change in Short Physical Performance Battery (SPPB) score at 6 months
Lasso di tempo: Baseline,3 months, 6 months
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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
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Change in skeletal muscle mass index (SMI) at 6 months
Lasso di tempo: Baseline,3 months, 6 months
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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
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Change in bone mineral density (BMD) at 6 months
Lasso di tempo: Baseline,6 months
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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
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Change in quality of life at 6 months
Lasso di tempo: Baseline,3 months, 6 months
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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
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Incidence of falls within 6 months
Lasso di tempo: 6 months
|
The number of participants who experienced fall events during the 6-month intervention period. |
6 months
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025LY056
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