- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Muğla
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Muğla, Muğla, 터키 (Türkiye), 48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: control group
Participants continued their usual care during the study period without a structured exercise program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Performance
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in flexibility
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in biceps skinfold thickness
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (기타 식별자: Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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