Combined Aerobic and Resistance Exercise in Peritoneal Dialysis Patients (CAPER-PD)
3 juin 2026 mis à jour par: Dilek GİBYELİ GENEK
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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Muğla
-
Muğla, Muğla, Turquie (Türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: control group
Participants continued their usual care during the study period without a structured exercise program.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical Performance
Délai: Baseline and after 8 weeks of intervention
|
Changes in physical performance assessed using the 6-minute walk test after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in right handgrip strength
Délai: Baseline and after 8 weeks of intervention
|
Changes in right handgrip strength measured in kilograms after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in left handgrip strength
Délai: Baseline and after 8 weeks of intervention
|
Changes in left handgrip strength measured in kilograms after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in leg strength
Délai: Baseline and after 8 weeks of intervention
|
Changes in lower extremity muscle strength measured using a leg and back dynamometer after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in flexibility
Délai: Baseline and after 8 weeks of intervention
|
Changes in flexibility assessed using the Modified Back-Saver Sit-and-Reach Test after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in Fat Tissue Index (FTI)
Délai: Baseline and after 8 weeks of intervention
|
Changes in Fat Tissue Index measured by by bioimpedance spectroscopy after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in Lean Tissue Index (LTI)
Délai: Baseline and after 8 weeks of intervention
|
Changes in Lean Tissue Index measured by by bioimpedance spectroscopy after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum IGF-1 levels
Délai: Baseline and after 8 weeks of intervention
|
Changes in serum insulin-like growth factor-1 (IGF-1) levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum ACTH levels
Délai: Baseline and after 8 weeks of intervention
|
Changes in serum adrenocorticotropic hormone (ACTH) levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum myostatin levels
Délai: Baseline and after 8 weeks of intervention
|
Changes in serum myostatin levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum irisin levels
Délai: Baseline and after 8 weeks of intervention
|
Changes in serum irisin levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in biceps skinfold thickness
Délai: Baseline and after 8 weeks of intervention
|
Changes in biceps skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in triceps skinfold thickness
Délai: Baseline and after 8 weeks of intervention
|
Changes in triceps skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in abdominal skinfold thickness
Délai: Baseline and after 8 weeks of intervention
|
Changes in abdominal skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2022
Achèvement primaire (Réel)
30 septembre 2022
Achèvement de l'étude (Réel)
30 septembre 2022
Dates d'inscription aux études
Première soumission
11 mai 2026
Première soumission répondant aux critères de contrôle qualité
3 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (Autre identifiant: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared to protect participant privacy and confidentiality.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .