- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07654478
Health Literacy-Based Multifactorial Program for Adults With Sarcopenia
The Effects of a Health Literacy-Based Multifactorial Intervention for Middle-Aged and Older Adults With Sarcopenia
Sarcopenia is a common age-related condition characterized by the progressive loss of muscle mass and function, which may lead to reduced physical performance, disability, and poorer quality of life. Exercise and nutritional management are considered the primary interventions for preventing and managing sarcopenia; however, successful implementation requires long-term lifestyle modifications. Previous studies have indicated that health literacy among the general population in Taiwan remains insufficient, potentially limiting individuals' ability to adopt and maintain healthy behaviors. Therefore, interventions that improve health literacy may help promote healthy aging and sarcopenia prevention.
The purpose of this study is to develop a sarcopenia-specific health literacy questionnaire and to evaluate the effectiveness of a health literacy-based multifactorial intervention among community-dwelling middle-aged and older adults. A total of 100 participants will be enrolled and assigned to either an intervention group (n=50) or a control group (n=50). The intervention group will participate in six 60-minute sessions consisting of health education and exercise training. Health literacy and other self-reported outcomes will be assessed before and after the intervention, with follow-up assessments conducted three months later. The study aims to determine whether the intervention can improve participants' health literacy and support the adoption of healthy lifestyle behaviors related to sarcopenia prevention and management.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is a nonrandomized controlled trial designed to evaluate the effects of a health literacy-based multifactorial intervention in middle-aged and older adults with sarcopenia. Participants will be recruited from outpatient rehabilitation referrals at Taipei Medical University Hospital and from the community. A total of 100 participants will be enrolled and assigned to either an intervention group (n=50) or a control group (n=50).
Eligible participants are adults aged 40 years or older who are willing to participate in a multifactorial intervention program. Participants will be excluded if they are unable to complete six intervention sessions and follow-up assessments over a 3-month period, have cognitive impairments that prevent them from understanding or completing questionnaires, or have medical conditions that contraindicate participation in physical activity.
The intervention consists of six 60-minute sessions delivered over the study period. Each session includes structured health education and exercise training aimed at improving health literacy, enhancing awareness of sarcopenia, and promoting healthy lifestyle behaviors. The control group will receive usual care without structured intervention.
Outcomes will be assessed at baseline, immediately post-intervention, and at 3-month follow-up. The primary outcome is health literacy, measured using a sarcopenia-specific health literacy questionnaire developed in this study. Secondary outcomes may include self-reported health behaviors and related functional indicators.
Data will be analyzed using SPSS version 22.0. Descriptive statistics will be used to summarize participant characteristics. Independent t-tests and/or repeated measures analyses will be used to compare changes between groups. A p-value of less than 0.05 will be considered statistically significant.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 110
- Taipei Medical University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- (1) Age ≥ 40 years old (2) has willingness to participate our multifactorial approach. (3) Participants eligible for intervention following assessment by a rehabilitation physician
Exclusion Criteria:
- (1) unable to complete all the sic sections of multifactorial approach and lost follow up. (2) unable to comprehend and finish the sarcopenia literacy questionnaire, or has other conditions that could not participation the activities. (3)Participants with other medical conditions that could not participate the intervention will be excluded.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Multicomponent Intervention Group
Participants in the intervention group will receive a structured multicomponent program designed to improve sarcopenia-related health literacy and promote healthy lifestyle behaviors. The program consists of six 60-minute sessions delivered over the intervention period. Each session includes health education focusing on sarcopenia awareness, risk factors, prevention strategies, and self-management, combined with supervised exercise training. The exercise component is designed to improve physical function and promote regular physical activity. Participants will receive guidance aimed at enhancing understanding and application of health information in daily life. |
A structured intervention consisting of six 60-minute sessions that combine health education and exercise training.
The program is designed to improve sarcopenia-related health literacy, increase awareness of sarcopenia prevention, and promote healthy lifestyle behaviors among middle-aged and older adults.
|
|
Nessun intervento: Usual Care Control Group
Participants receive usual care and do not participate in the structured intervention program.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Sarcopenia literacy quscitonaire
Lasso di tempo: Baseline, immediately post-intervention, and 3-month follow-up
|
Sarcopenia-related health literacy will be assessed using a sarcopenia-specific health literacy questionnaire developed in this study.
The questionnaire evaluates participants' knowledge, understanding, and ability to apply health information related to sarcopenia prevention and management.
Higher scores indicate better health literacy.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 113TMUHP0
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Stile di vita
-
Rush University Medical CenterCompletatoAdvanced Cardiac Life Support, rianimazione cardiopolmonare, volume corrente, ventilazione manualeStati Uniti
-
Yale-NUS CollegeCompletatoIl focus dello studio sono le risposte dei pazienti a un questionario sulla gestione dell'obesità amministrato dal SGH Life CenterSingapore
-
The Leeds Teaching Hospitals NHS TrustAttivo, non reclutanteFerite e lesioni | Chirurgia | Riabilitazione | Disturbo ortopedico | Misure di esito riferite dal paziente | Valutazione della disabilità | Recupero della funzione | Trauma multiplo/lesioni | Centri traumatologici | Indici di gravità del trauma | Advanced Trauma Life Support CareRegno Unito
-
Yale-NUS CollegeCompletatoIl focus dello studio sono le risposte dei pazienti a un questionario sulla gestione dell'obesità amministrato dal SGH Life CenterSingapore
Prove cliniche su Multicomponent Intervention
-
Peking UniversityShandong Maternal and Child Health HospitalAttivo, non reclutante
-
Peking UniversityShandong Maternal and Child Health HospitalAttivo, non reclutantePrevenzione dell'obesità infantileCina
-
University of ZurichETH Zurich (Switzerland)Reclutamento
-
Superior UniversityAttivo, non reclutanteArtrosi al ginocchioPakistan
-
Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
-
KK Women's and Children's HospitalCompletatoCambio di pesoSingapore
-
Ege Miray TopcuCompletatoAnsia | Terapia di supporto gestita da infermiere | Interventi infermieristiciTurchia (Türkiye)
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD); American...Non ancora reclutamentoIpertensione | Ipertensione complicata con il diabete di tipo 2Stati Uniti
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); Virginia Commonwealth UniversityReclutamentoObesità | Cancro | Attività fisica | Dieta | Sopravvivenza al cancroStati Uniti
-
University of PittsburghCompletatoDistrofia muscolare di DuchenneStati Uniti