- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07634211
Combined Aerobic and Resistance Exercise in Peritoneal Dialysis Patients (CAPER-PD)
Combined Aerobic and Resistance Exercise in Peritoneal Dialysis Patients: A Randomized Controlled Trial
The goal of this randomized controlled trial was to learn whether a combined aerobic and resistance exercise program could improve physical function and muscle health in people receiving peritoneal dialysis. Researchers compared an exercise group with a control group to evaluate the effects of regular exercise.
The main questions the study aimed to answer were:
- Can regular exercise improve physical performance and muscle strength in people receiving peritoneal dialysis?
- Can regular exercise improve body composition and blood markers related to muscle health?
Before the exercise program, participants completed a one-month training period to learn the exercises and practice them safely.
Participants in the exercise group:
- Performed combined aerobic and resistance exercises for 8 weeks
- Completed assessments before and after the exercise program
Participants in the control group:
- Continued their usual care
- Completed assessments before and after the study period
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
People receiving peritoneal dialysis often experience reduced physical function, muscle weakness, and changes in body composition. This randomized controlled trial evaluated the effects of a combined aerobic and resistance exercise program in adults receiving peritoneal dialysis.
Before the intervention, participants completed a one-month training and adaptation period to learn the exercises and ensure safe participation. Participants were then assigned to either an exercise group or a control group. The exercise group performed a structured combined aerobic and resistance exercise program for 8 weeks, while the control group continued usual care.
Researchers evaluated physical performance, muscle strength, body composition, and blood markers related to muscle health before and after the intervention period. The study aimed to determine whether regular exercise could improve physical function and muscle health in people receiving peritoneal dialysis.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Muğla
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Muğla, Muğla, Turchia (Türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults aged 18 years or older
- Receiving peritoneal dialysis for at least 6 months
- Ability to sit and stand independently
Exclusion Criteria:
- Myocardial infarction within the previous 6 months
- History of cardiac surgery
- Uncontrolled hypertension
- Pericardial or pleural effusion
- Aortic stenosis
- Active lower extremity amputation, prosthesis, or fracture
- History of osteoporotic fractures
- Regular participation in sports or structured exercise
- Advanced cognitive impairment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: exercise group
Participants performed a combined aerobic and resistance exercise program for 8 weeks.
|
Participants performed a structured combined aerobic and resistance exercise program for 8 weeks.
Before the intervention period, participants completed a one-month training and adaptation phase to learn the exercises and ensure safe participation.
The exercise program aimed to improve physical performance, muscle strength, and muscle health in people receiving peritoneal dialysis.
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Nessun intervento: control group
Participants continued their usual care during the study period without a structured exercise program.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical Performance
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in physical performance assessed using the 6-minute walk test after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in right handgrip strength
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in right handgrip strength measured in kilograms after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in left handgrip strength
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in left handgrip strength measured in kilograms after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in leg strength
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in lower extremity muscle strength measured using a leg and back dynamometer after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in flexibility
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in flexibility assessed using the Modified Back-Saver Sit-and-Reach Test after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in Fat Tissue Index (FTI)
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in Fat Tissue Index measured by by bioimpedance spectroscopy after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in Lean Tissue Index (LTI)
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in Lean Tissue Index measured by by bioimpedance spectroscopy after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in serum IGF-1 levels
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in serum insulin-like growth factor-1 (IGF-1) levels after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in serum ACTH levels
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in serum adrenocorticotropic hormone (ACTH) levels after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in serum myostatin levels
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in serum myostatin levels after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in serum irisin levels
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in serum irisin levels after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in biceps skinfold thickness
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in biceps skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in triceps skinfold thickness
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in triceps skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Changes in abdominal skinfold thickness
Lasso di tempo: Baseline and after 8 weeks of intervention
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Changes in abdominal skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
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Baseline and after 8 weeks of intervention
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- Uchiyama K, Washida N, Morimoto K, Muraoka K, Kasai T, Yamaki K, Miyashita K, Wakino S, Itoh H. Home-based Aerobic Exercise and Resistance Training in Peritoneal Dialysis Patients: A Randomized Controlled Trial. Sci Rep. 2019 Feb 22;9(1):2632. doi: 10.1038/s41598-019-39074-9.
- Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
- Lu Y, Wang Y, Lu Q. Effects of Exercise on Muscle Fitness in Dialysis Patients: A Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):291-302. doi: 10.1159/000502635. Epub 2019 Sep 3.
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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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (Altro identificatore: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
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