- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Muğla
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Muğla, Muğla, Turkey (Türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: control group
Participants continued their usual care during the study period without a structured exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Performance
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
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Changes in leg strength
Time Frame: 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.
|
Baseline and after 8 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in flexibility
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum IGF-1 levels
Time Frame: 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
Time Frame: Baseline and after 8 weeks of intervention
|
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
|
|
Changes in serum myostatin levels
Time Frame: Baseline and after 8 weeks of intervention
|
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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in biceps skinfold thickness
Time Frame: 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
|
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Changes in triceps skinfold thickness
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (Other Identifier: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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