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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Li Sun, Master' degree
- Telefonnummer: 8615896264283
- E-post: sunliborntowin@126.com
Studiesteder
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Jiangsu
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Nantong, Jiangsu, Kina, 226000
- Rekruttering
- Nantong First People's Hospital
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Ta kontakt med:
- Yan Hai Gu, Bachelor's degree
- Telefonnummer: 8613862938568
- E-post: guhaiyan.2009@163.com
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Nantong, Jiangsu, Kina, 226001
- Rekruttering
- Nantong First People's Hospital
-
Ta kontakt med:
- Li Sun, Master' degree
- Telefonnummer: 8615896264283
- E-post: sunliborntowin@126.com
-
Underetterforsker:
- Yan Hai Gu, Bachelor
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Underetterforsker:
- Qian Zhi Gong, Master
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Underetterforsker:
- Hua Guan Xu, Doctor
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Hovedetterforsker:
- Yu Yu Sun, Doctor
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Underetterforsker:
- Qin Xuan, Bachelor
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Underetterforsker:
- Yan Dong Zhu, Master
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in frailty phenotype score at 6 months
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in handgrip strength at 6 months
Tidsramme: 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
Tidsramme: 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
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Change in skeletal muscle mass index (SMI) at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
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The number of participants who experienced fall events during the 6-month intervention period. |
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
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Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
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Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025LY056
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