Combined Aerobic and Resistance Exercise in Peritoneal Dialysis Patients (CAPER-PD)
3. juni 2026 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Muğla
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Muğla, Muğla, Tyrkia (Türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
|
Ingen inngripen: control group
Participants continued their usual care during the study period without a structured exercise program.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Physical Performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in flexibility
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in biceps skinfold thickness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2022
Primær fullføring (Faktiske)
30. september 2022
Studiet fullført (Faktiske)
30. september 2022
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (Annen identifikator: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared to protect participant privacy and confidentiality.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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