血液透析患者における混合型透析中運動トレーニングプログラムが上肢および下肢の身体組成、機能的能力、筋酸素化に及ぼす影響
血液透析患者における混合型透析中運動トレーニングプログラムの上肢および下肢の体組成、機能的能力、筋酸素化への効果
Chronic kidney disease (CKD) is a progressive clinical condition that affects a growing number of people worldwide. While advances in haemodialysis techniques have led to notable improvements in survival rates and the quality of life (QoL) of patients with CKD (PwCKD), significant complications persist, primarily associated with chronic uremia. These include skeletal muscle atrophy, reduced muscular strength and diminished functional capacity.
Recent studies support the role of systematic exercise as a non-pharmacological strategy to reduce issues and improve musculoskeletal function among haemodialysis patients. Specifically, intradialytic exercise gained ground due to its efficiency in time utilization and elimination of transport burden. Nevertheless, most of the intradialytic exercise programs implement aerobic exercise and there is a lack of studies investigating combined strength and aerobic exercise modalities, which may offer more comprehensive physiological benefits.
The aim of the randomized controlled trial (RCT) is to examine whether a 6-month combined aerobic and resistance exercise program, implemented during haemodialysis sessions, could affect body composition, muscle oxygenation of the lower and upper extremities, and functional capacity of patients that underwent haemodialysis.
Forty patients will be randomly allocated into two groups: Group A (Exercise Group) will undergo 3 sessions per week of an intradialytic exercise program for 6 months and Group B (Control Group) will receive the usual care without participating in organized exercise programs.
Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') will include demographics and clinical history, body composition analysis via bioelectrical impedance analysis, muscle oxygenation monitoring of the vastus lateralis and biceps brachii muscles at rest and during exercise using near-infrated spectroscopy (NIRS) technology. Functional capacity will be assessed through validated tests: Six-minute walk test (6MWT), 30-second sit-to-stand test, five-repetition sit-to-stand test (5STS), handgrip strength, 4-meter gait speed test. Additionally, we will use questionnaires assessing physical activity using International Physical Activity Questionnaire (IPAQ), depression using Beck Depression Inventory (BDI), stress using Generalized Anxiety Disorder 7-item scale(GAD-7) and the QoL using Kidney Disease Quality of Life Short Form(KDQOL-SF) of people that underwent dialysis.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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-
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Thessaloniki、ギリシャ、57001
- Sports Medicine Laboratory, Aristotle University of Thessaloniki
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age > 18 and <80 years, either gender
- Confirmed diagnosis
- Patients undergoing maintenance hemodialysis therapy for at least 6 months.
Exclusion Criteria:
- Acute myocardial infraction
- Severe valvular disease
- Potentially malignant arrhythmias
- Unstable angina
- Hospitalized patients
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Neurological, or orthopedic limitations/non-ambulant status
- Cognitive or psychiatric disorders
- Poor regulation of comorbidities
- Already participating in organized exercise programs
- Current pregnancy
- Inability/unwillingness to give informed consent
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：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Exercise
Exercise Group, 6- month combined aerobic and strength exercise |
Patients randomly assigned to this group will be invited to attend a 6 month exercise program. The 6-month exercise intervention will be conducted three times per week during the first two hours of each hemodialysis session at the 2nd Nephrology Clinic at AHEPA University Hospital. Each session will begin with a warm-up phase, followed by aerobic exercise using bedside-adapted cycle ergometers. Exercise duration will initially be set at 30 minutes and progressively increased to 60 minutes, performed at moderate intensity (12-13 on the 6-20 Borg Rating of Perceived Exertion scale). After the first month, resistance training will be gradually introduced, initially using body weight and subsequently incorporating elastic resistance bands. Each session will conclude with a cool-down period. |
|
介入なし：Usual care
Control Group, 6- month without participating in organized exercise activities, no intervention |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
臨床的および人口統計学的特性
時間枠：ベースライン
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ベースライン
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臨床的および人口統計学的特性
時間枠：6ヶ月
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6ヶ月
|
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4メートル歩行速度テスト
時間枠：ベースライン
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ベースライン
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4メートル歩行速度テスト
時間枠：6か月
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6か月
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ベースライン下肢ダイナモメーター
時間枠：ベースライン
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ベースライン
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ベースライン脚部ダイナモメーター
時間枠：6か月
|
6か月
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Muscle oxygenation Assessment-MOXY
時間枠：Baseline
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Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). |
Baseline
|
|
Muscle oxygenation Assessment-MOXY
時間枠：6-month
|
Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). |
6-month
|
|
Body composition analysis
時間枠：Baseline
|
Bioelectrical impedance analysis (Bodystat QuadScan 4000). |
Baseline
|
|
Body composition analysis
時間枠：6-month
|
Bioelectrical impedance analysis (Bodystat QuadScan 4000). |
6-month
|
|
Six minute walk test
時間枠：Baseline
|
Aerobic capacity |
Baseline
|
|
Six minute walk test
時間枠：6-month
|
Aerobic capacity |
6-month
|
|
JAMAR SMART Hand Dynamometer
時間枠：Baseline
|
Handgrip Strength |
Baseline
|
|
JAMAR SMART Hand Dynamometer
時間枠：6- month
|
Handgrip Strength |
6- month
|
|
30-second Sit-to-Stand Test
時間枠：Baseline
|
Lower limb functional capacity |
Baseline
|
|
30-second Sit-to-Stand Test
時間枠：6- month
|
Lower limb functional capacity |
6- month
|
|
Five-Repetition Sit-to-Stand Test (5STS)
時間枠：Baseline
|
Lower limb functional capacity |
Baseline
|
|
Five-Repetition Sit-to-Stand Test (5STS)
時間枠：6- month
|
Lower limb functional capacity |
6- month
|
|
International Physical Activity Questionnaire (IPAQ).
時間枠：Baseline
|
Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. |
Baseline
|
|
International Physical Activity Questionnaire (IPAQ).
時間枠：6- month
|
Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. |
6- month
|
|
Beck Depression Inventory (BDI)
時間枠：Baseline
|
Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). |
Baseline
|
|
Beck Depression Inventory (BDI)
時間枠：6- month
|
Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). |
6- month
|
|
Generalized Anxiety Disorder-7 scale (GAD-7).
時間枠：Baseline
|
Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. |
Baseline
|
|
Generalized Anxiety Disorder-7 scale (GAD-7).
時間枠：6- month
|
Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. |
6- month
|
|
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
時間枠：Baseline
|
Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. |
Baseline
|
|
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
時間枠：6- month
|
Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. |
6- month
|
協力者と研究者
捜査官
捜査官
- スタディチェア：Evangelia Kouidi, Professor、Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
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
その他の研究ID番号
- 121/2022
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
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