NCT07634211

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

May 11, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Peritoneal DialysisexercisePhysical PerformanceMuscle StrengthBody Composition

Outcome Measures

Primary Outcomes (4)

  • Physical Performance

    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

    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

    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

    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

Secondary Outcomes (7)

  • Changes in flexibility

    Baseline and after 8 weeks of intervention

  • Changes in Fat Tissue Index (FTI)

    Baseline and after 8 weeks of intervention

  • Changes in Lean Tissue Index (LTI)

    Baseline and after 8 weeks of intervention

  • Changes in serum IGF-1 levels

    Baseline and after 8 weeks of intervention

  • Changes in serum ACTH levels

    Baseline and after 8 weeks of intervention

  • +2 more secondary outcomes

Other Outcomes (3)

  • Changes in biceps skinfold thickness

    Baseline and after 8 weeks of intervention

  • Changes in triceps skinfold thickness

    Baseline and after 8 weeks of intervention

  • Changes in abdominal skinfold thickness

    Baseline and after 8 weeks of intervention

Study Arms (2)

exercise group

EXPERIMENTAL

Participants performed a combined aerobic and resistance exercise program for 8 weeks.

Behavioral: Combined Aerobic and Resistance Exercise

control group

NO INTERVENTION

Participants continued their usual care during the study period without a structured exercise program.

Interventions

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.

exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Receiving peritoneal dialysis for at least 6 months
  • Ability to sit and stand independently

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital

Muğla, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31480056BACKGROUND
  • 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.

    PMID: 21975737BACKGROUND
  • 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.

    PMID: 30796338BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to either an exercise group or a control group and followed in parallel throughout the study period
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Nephrology

Study Record Dates

First Submitted

May 11, 2026

First Posted

June 8, 2026

Study Start

July 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and confidentiality.

Locations