- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Muğla
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Muğla, Muğla, Türkei (türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: exercise group
Participants performed a combined aerobic and resistance exercise program for 8 weeks.
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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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Kein Eingriff: control group
Participants continued their usual care during the study period without a structured exercise program.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Physical Performance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in flexibility
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes in biceps skinfold thickness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (Andere Kennung: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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