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Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)

2026年9月14日 更新者：Ricerca Nefrocenter

Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease

The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:

  • Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?
  • Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?

Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.

Participants will:

  • Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.
  • Attend hemodialysis sessions as scheduled.
  • Complete physical performance and body composition assessments at baseline and after 6 months.
  • Complete questionnaires about health and quality of life.

The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

312

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • イタリア
      • Torre del Greco、イタリア、80059
        • 募集
        • NefroCenter Dialysis Centers
        • コンタクト：
        • 主任研究者：
          • Ersilia Satta, PhD MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Age ≥18 years.
  • Receiving maintenance hemodialysis for more than 3 months.
  • Clinically stable condition.
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Unstable angina.
  • Uncontrolled hypertension.
  • Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：支持療法
  • 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
アクティブコンパレータ：Cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13. Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
行動：Intradialytic aerobic exercise using a cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13). Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
アクティブコンパレータ：Elastic band resistance training
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance was progressively adjusted according to individual tolerance and correct exercise execution. Sessions were supervised by exercise professionals and monitored by dialysis nurses.
行動：Intradialytic elastic-band resistance exercise
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.
介入なし：Control
Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program. Clinical assessments and follow-up evaluations were performed according to the study protocol.

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
Incidence of intradialytic intolerance and hemodynamic instability
時間枠：Baseline to 6 months
Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
Baseline to 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximal workload during cycle ergometer stress testing
時間枠：Baseline to 6 months
Changes in maximal workload achieved during cycle ergometer stress testing.
Baseline to 6 months
Six-minute walk test distance
時間枠：Baseline and 6 months
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Baseline and 6 months
Step-test performance
時間枠：Baseline and 6 months
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Baseline and 6 months
Chair-stand test performance
時間枠：Baseline and 6 months
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Baseline and 6 months
Handgrip strength
時間枠：Baseline and 6 months
Changes in handgrip strength measured using a hand dynamometer.
Baseline and 6 months
Weekly exercise time
時間枠：Throughout the 6-month intervention period
Changes in the total amount of exercise completed per week during the intervention period.
Throughout the 6-month intervention period
Fat-free mass and fat mass
時間枠：Baseline to 6 months
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
Baseline to 6 months
Bone mineral content
時間枠：Baseline and 6 months
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
Baseline and 6 months
Bone mineral status (T-score)
時間枠：Baseline and 6 months
Changes in T-score as an indicator of bone mineral status.
Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
時間枠：Baseline and 6 months
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
Baseline and 6 months
Anthropometric circumferences
時間枠：Baseline and 6 months
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
Baseline and 6 months
Health-related quality of life
時間枠：Baseline to 6 months
Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire. The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.
Baseline to 6 months
Medication burden
時間枠：Baseline to 6 months
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
Baseline to 6 months
Dialysis adequacy
時間枠：Baseline to 6 months
Changes in dialysis adequacy expressed as Kt/V.
Baseline to 6 months
Dialysis session duration
時間枠：Baseline and 6 months
Changes in the duration of the hemodialysis session (min).
Baseline and 6 months
Blood flow rate
時間枠：Baseline and 6 months
Changes in blood flow rate (Qb) during hemodialysis.
Baseline and 6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ricerca Nefrocenter

協力者

Federico II University
University of Naples

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月1日

一次修了 (実際)

2025年10月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年8月24日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 0079556CE
  • CUP E63C22002050006 (その他の助成金/資金番号：National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)

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?

未定

IPD プランの説明

The decision regarding sharing of individual participant data (IPD) has not yet been finalized. Data sharing will be evaluated after study completion, taking into account ethical, legal, privacy, and data protection requirements.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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