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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Muğla
-
Muğla、Muğla、トルコ(Türkiye)、48000
- Mugla Sitki Kocman University Faculty of Medicine, Mugla Training and Research Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
|
介入なし:control group
Participants continued their usual care during the study period without a structured exercise program.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Performance
時間枠: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
時間枠: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
時間枠: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
|
|
Changes in leg strength
時間枠:Baseline and after 8 weeks of intervention
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in flexibility
時間枠: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)
時間枠: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)
時間枠:Baseline and after 8 weeks of intervention
|
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
時間枠:Baseline and after 8 weeks of intervention
|
Changes in serum insulin-like growth factor-1 (IGF-1) levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum ACTH levels
時間枠:Baseline and after 8 weeks of intervention
|
Changes in serum adrenocorticotropic hormone (ACTH) levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum myostatin levels
時間枠:Baseline and after 8 weeks of intervention
|
Changes in serum myostatin levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in serum irisin levels
時間枠:Baseline and after 8 weeks of intervention
|
Changes in serum irisin levels after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in biceps skinfold thickness
時間枠: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
|
|
Changes in triceps skinfold thickness
時間枠:Baseline and after 8 weeks of intervention
|
Changes in triceps skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
|
Changes in abdominal skinfold thickness
時間枠:Baseline and after 8 weeks of intervention
|
Changes in abdominal skinfold thickness measured using skinfold caliper assessment after 8 weeks of combined aerobic and resistance exercise.
|
Baseline and after 8 weeks of intervention
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PD-EX-2022
- Ethics Approval 9/XVI-2022 (その他の識別子:Muğla Sıtkı Koçman University Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。