Effects of Intradialytic Exercise on Muscle Oxygenation and Dialysis Adequacy

Официальное название

Investigation of the Effects of Intradialytic Combined Exercises on Dialysis Parameters and Muscle Oxygenation in Sarcopenic Hemodialysis Patients

Обзор

This randomized controlled trial will evaluate the effects of a 12-week intradialytic combined exercise program, consisting of aerobic and resistance training, in patients with stage 5 chronic kidney disease receiving maintenance hemodialysis. Sarcopenia, a progressive loss of muscle mass and strength, is common in this population due to chronic disease burden and the sedentary nature of dialysis sessions. The intervention group will perform structured exercise three times per week during the first two hours of dialysis, while the control group will continue routine dialysis care without exercise. The primary aim is to investigate whether intradialytic exercise can improve dialysis adequacy and muscle oxygenation, and reduce sarcopenia severity. Secondary objectives include evaluating changes in physical performance, muscle strength, fatigue levels, and health-related quality of life. Approximately 40 participants will be randomized into intervention and control groups. Outcomes will be assessed through clinical measurements, functional tests, and patient-reported questionnaires before and after the intervention period.

Подробное описание

Sarcopenia is a progressive loss of skeletal muscle mass and strength, associated with physical disability, poor quality of life, and increased mortality risk. Although commonly linked to aging, sarcopenia may also develop as a secondary condition in patients with chronic kidney disease (CKD) due to malnutrition, low physical activity, or treatment-related catabolism. In individuals undergoing hemodialysis, protein catabolism, inflammation, and nutrient loss are accelerated, further contributing to sarcopenia. Prolonged dialysis sessions also enforce sedentary behavior, exacerbating physical decline.

Exercise interventions have been shown to delay sarcopenia progression, improve functional capacity, and support survival. Intradialytic exercise, performed during dialysis sessions, offers practical advantages as it is time-efficient, conducted under medical supervision, and associated with better adherence compared to exercise outside dialysis. Combined programs involving both aerobic and resistance training are particularly effective in improving dialysis adequacy, reducing fatigue, and supporting muscle maintenance.

Muscle oxygenation plays an important role in sarcopenia. Factors such as oxidative stress, mitochondrial dysfunction, and impaired circulation can reduce oxygen delivery and utilization, leading to muscle weakness and atrophy. Hemodialysis itself alters microcirculation and oxygenation, negatively affecting muscle recovery. Near-infrared spectroscopy (NIRS) enables non-invasive monitoring of muscle oxygenation and has demonstrated that exercise interventions can improve tissue oxygenation parameters.

This randomized controlled trial will investigate the effects of a 12-week intradialytic combined exercise program-including aerobic and resistance training-on dialysis adequacy, muscle oxygenation, and sarcopenia severity in patients with CKD undergoing maintenance hemodialysis. Secondary outcomes will include physical performance, fatigue, and health-related quality of life.

The study will be conducted at Kadıköy Dialife Ata Dialysis Center in Istanbul, Turkey. A total of 40 participants aged 18-65 with stage 5 CKD on maintenance hemodialysis for at least one year, and diagnosed with sarcopenia according to EWGSOP2 criteria, will be enrolled. Participants will be randomly assigned to either an exercise group or a control group.

Intervention group: Participants will receive a 12-week intradialytic combined exercise program performed three times per week during the first two hours of dialysis sessions. Aerobic training will consist of supine cycling with a portable ergometer at 45-70% of maximum heart rate, adjusted progressively and monitored with pulse oximetry and the Borg scale. Resistance training will include exercises with elastic bands and ankle weights targeting upper and lower extremities, performed as 2 sets of 8-12 repetitions with progressive load increments according to ACSM guidelines. Each session will also include a 10-minute warm-up and cool-down with stretching and breathing exercises.

Control group: Participants will receive routine hemodialysis care without structured exercise. After completion of the study, the exercise program will be offered to this group.

Safety monitoring: Exercise intensity will be individualized. Sessions will be interrupted in cases of chest pain, dizziness, hypotension, severe fatigue, or excessive perceived exertion. Continuous monitoring of heart rate, blood pressure, and oxygen saturation will be conducted.

Primary outcomes will include dialysis adequacy (Kt/V, URR) and muscle oxygenation (SmO₂) assessed by NIRS. Secondary outcomes will include handgrip strength, body composition, peripheral muscle strength, the 6-minute walk test (6MWT), the Short Physical Performance Battery (SPPB), fatigue severity, quality of life (KDQOL-36), and selected laboratory parameters.

Statistical analysis will be performed using appropriate parametric or non-parametric tests according to data distribution. Significance will be set at p \< 0.05.

Вмешательства

• Другое EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  Participants in this arm will receive a 12-week intradialytic combined exercise program, performed three times per week during the first two hours of hemodialysis. Each session will begin with a 10-minute warm-up and end with a 10-minute cool-down (stretching and breathing exercises). Aerobic component: Supine cycling using a portable ergometer at 45-70% of maximum heart rate, monitored with pulse oximetry and Borg scale, progressively increased every 1-2 weeks. Resistance component: Exercises

Первичные конечные точки

• Muscle Oxygen Saturation (SmO₂, %) [Срок оценки: Baseline and after 12 weeks]
• Total Hemoglobin Concentration [Срок оценки: Baseline and after 12 weeks]
• Dialysis Adequacy - Kt/V [Срок оценки: Baseline and after 12 weeks]
• Dialysis Adequacy - Urea Reduction Ratio [Срок оценки: Baseline and after 12 weeks]

Вторичные конечные точки (7)

• Handgrip Strength [Срок оценки: Baseline]
• Fat-Free Mass Index [Срок оценки: Baseline]
• Peripheral Muscle Strength [Срок оценки: Baseline and after 12 weeks]
• Six-Minute Walk Test (6MWT) [Срок оценки: Baseline and after 12 weeks]
• Short Physical Performance Battery (SPPB) [Срок оценки: Baseline and after 12 weeks]
• Fatigue Severity Scale (FSS) [Срок оценки: Baseline and after 12 weeks]
• Kidney Disease Quality of Life (KDQOL-36) [Срок оценки: Baseline and after 12 weeks]

Критерии участия

Критерии включения

Age between 18 and 65 years

Diagnosed with stage 5 chronic kidney disease (end-stage renal disease) according to GFR, undergoing maintenance hemodialysis for at least 1 year

Diagnosed with sarcopenia based on EWGSOP2 (2018) criteria

Able to read and write

Cooperative and able to follow instructions

Voluntary participation with written informed consent

Критерии исключения

Presence of orthopedic or neurological disorders affecting mobility or exercise capacity

Uncontrolled diabetes mellitus or uncontrolled hypertension

Untreated intradialytic hypotension

Heart failure

Unstable angina

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Kadıköy Ata Dialysis Center — Istanbul

Публикации

• Yu MD, Zhang HZ, Zhang Y, Yang SP, Lin M, Zhang YM, Wu JB, Hong FY, Chen WX. Relationship between chronic kidney disease and sarcopenia. Sci Rep. 2021 Oct 15;11(1):20523. doi: 10.1038/s41598-021-99592-3. PMID 34654871
• Umakanthan M, Li JW, Sud K, Duque G, Guilfoyle D, Cho K, Brown C, Boersma D, Gangadharan Komala M. Prevalence and Factors Associated with Sarcopenia in Patients on Maintenance Dialysis in Australia-A Single Centre, Cross-Sectional Study. Nutrients. 2021 Sep 20;13(9):3284. doi: 10.3390/nu13093284. PMID 34579163
• Shen S, Liao Q, Lyu P, Wang J, Lin L. Myricanol prevents aging-related sarcopenia by rescuing mitochondrial dysfunction via targeting peroxiredoxin 5. MedComm (2020). 2024 Jun 12;5(6):e566. doi: 10.1002/mco2.566. eCollection 2024 Jun. PMID 38868327
• Shahar S, Kamaruddin NS, Badrasawi M, Sakian NI, Abd Manaf Z, Yassin Z, Joseph L. Effectiveness of exercise and protein supplementation intervention on body composition, functional fitness, and oxidative stress among elderly Malays with sarcopenia. Clin Interv Aging. 2013;8:1365-75. doi: 10.2147/CIA.S46826. Epub 2013 Oct 9. PMID 24143082
• Savaş, S. (2015). Sarkopeniden korunma. Ege Tıp Dergisi, 54(0), 29-36. https://doi.org/10.19161/etd.344148
• Sanchez-Tocino ML, Gonzalez-Parra E, Miranda Serrano B, Gracia-Iguacel C, de-Alba-Penaranda AM, Lopez-Gonzalez A, Garcia Olegario M, Ortiz A, Mas-Fontao S. Evaluation of the impact of an intradialytic exercise programme on sarcopaenia in very elderly haemodialysis patients. Clin Kidney J. 2022 Feb 15;15(8):1514-1523. doi: 10.1093/ckj/sfac046. eCollection 2022 Aug. PMID 35892024
• Sabatino A, Cuppari L, Stenvinkel P, Lindholm B, Avesani CM. Sarcopenia in chronic kidney disease: what have we learned so far? J Nephrol. 2021 Aug;34(4):1347-1372. doi: 10.1007/s40620-020-00840-y. Epub 2020 Sep 2. PMID 32876940
• Pipili C, Grapsa E, Tripodaki ES, Ioannidou S, Manetos C, Parisi M, Nanas S. Changes in skeletal muscle microcirculation after a hemodialysis session correlates with adequacy of dialysis. Int J Nephrol Renovasc Dis. 2015 Jun 8;8:59-64. doi: 10.2147/IJNRD.S68639. eCollection 2015. PMID 26089698

Идентификаторы

NCT: NCT07151742 · 2025-123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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