Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients
2026年7月16日 更新者：Hebatuallah Abdelhaleem Elhabiby、Tanta University
Comparing the Effect of Intradialytic and Home-Based Exercise on Health Outcomes, Quality of Life, Self-Esteem, and Sexual Function in Female Hemodialysis Patients
This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks.
The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.
調査の概要
研究の種類
介入
入学 (実際)
90
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。
研究場所
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Gharbia Governorate
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Tanta、Gharbia Governorate、エジプト、31511
- Tanta University Hospitals
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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:
- Female patients older than 18 years.
- Clinically stable.
- Receiving regular maintenance hemodialysis three times per week for at least three months.
- Able to perform mild- to moderate-intensity exercise.
Exclusion Criteria:
- Physical limitations preventing exercise.
- Acute illness.
- Unstable cardiovascular disease.
- Severe orthopedic or neurological disorders.
- Cognitive impairment affecting cooperation.
- Dialysis instability.
- Severe chronic kidney disease-mineral and bone disorder.
- Significant anemia.
- Retinal hemorrhage.
- History of hyperthyroidism.
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 |
|---|---|
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実験的：Intradialytic Exercise
Participants performed low- to moderate-intensity aerobic and resistance exercises during the first two hours of hemodialysis, three times per week for 12 weeks.
Each session included a 5-minute warm-up, followed by aerobic and resistance exercises.
The conditioning phase started at 10 minutes and gradually increased to 30 minutes according to tolerance, followed by 5 minutes of relaxation and breathing exercises.
Exercise intensity was maintained at 60%-70% of maximal heart rate and monitored using the Borg scale.
Sessions were supervised by a trained dialysis nurse.
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A supervised low- to moderate-intensity aerobic and resistance exercise program performed during the first two hours of hemodialysis, three times per week for 12 weeks.
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実験的：Home-Based Exercise
Participants performed a structured home-based exercise program for 30 minutes per day, at least three to five times per week, for 12 weeks.
The program included walking, bodyweight resistance exercises, and flexibility routines.
Participants received instructions on safe exercise performance and were advised to adjust the exercise intensity according to tolerance.
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A structured home-based exercise program consisting of walking, bodyweight resistance exercises, and flexibility routines for 30 minutes per day, at least three to five times per week for 12 weeks.
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介入なし：Control
Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.
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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 |
|---|---|---|
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Health-Related Quality of Life
時間枠：Baseline and 12 weeks
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Change in Health-Related Quality of Life was assessed by the 36-Item Short Form Survey.
The 36-Item Short Form Survey consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, role limitations due to emotional problems, and emotional well-being.
Each domain is scored from 0 to 100, with 0 representing the lowest possible health status and 100 representing the highest possible health status.
Higher scores indicate better health-related quality of life.
The validated Arabic version was used.
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Baseline and 12 weeks
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Self-Esteem
時間枠：Baseline and 12 weeks
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Change in Self-Esteem was assessed by the Rosenberg Self-Esteem Scale.
The Rosenberg Self-Esteem Scale consists of 10 items assessing global self-esteem, including five positively worded and five negatively worded statements.
Higher total scores indicate higher self-esteem.
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Baseline and 12 weeks
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Female sexual function
時間枠：Baseline and 12 weeks
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Change in Female Sexual Function was assessed by the Female Sexual Function Index.
The Female Sexual Function Index consists of 19 items covering six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain.
The total score ranges from 2 to 36, with higher scores indicating better sexual function.
The validated Arabic version was used.
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Baseline and 12 weeks
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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
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)
2025年3月1日
一次修了 (実際)
2025年6月1日
研究の完了 (実際)
2025年6月1日
試験登録日
最初に提出
2026年7月16日
QC基準を満たした最初の提出物
2026年7月16日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月16日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 36264PR1100/2/25
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?
はい
IPD プランの説明
De-identified individual participant data underlying the results reported in the publication will be made available to other researchers upon reasonable request.
IPD 共有時間枠
Beginning immediately after publication of the study results and continuing for 2 years.
IPD 共有アクセス基準
De-identified individual participant data will be available to researchers who submit a methodologically sound proposal.
Requests should be directed to the corresponding author at hebaelhabiby@gmail.com.
Requests will be reviewed by the study investigators, and approved data will be provided for the purposes specified in the proposal, subject to an appropriate data use agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
いいえ
米国FDA規制機器製品の研究
いいえ
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