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NCT Number: NCT07151742

Effects of Intradialytic Exercise on Muscle Oxygenation and Dialysis Adequacy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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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Treatment and study plan

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Other

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 with elastic bands and ankle weights targeting major upper and lower extremity muscle groups (non-fistula arm). Performed in 2 sets of 8-12 repetitions, with progressive loading based on ACSM guidelines.

All sessions will be supervised by trained physiotherapists and dialysis staff to ensure safety and adherence

Other names: intradialytic exercise

Primary outcomes

  1. Muscle Oxygen Saturation (SmO₂, %)

    Time frame: Baseline and after 12 weeks

    Muscle oxygen saturation (SmO₂) will be measured non-invasively using near-infrared spectroscopy (Moxy device) placed over the vastus lateralis muscle. Average SmO₂ values will be recorded at rest, during a 6-minute walk test, and during post-exercise recovery to assess local oxygen delivery and utilization.

  2. Total Hemoglobin Concentration

    Time frame: Baseline and after 12 weeks

    Total hemoglobin concentration will be measured non-invasively using near-infrared spectroscopy (Moxy device) placed over the vastus lateralis muscle. Values will be recorded at rest, during a 6-minute walk test, and during post-exercise recovery to evaluate local oxygen delivery and utilization.

  3. Dialysis Adequacy - Kt/V

    Time frame: Baseline and after 12 weeks

    Dialysis adequacy will be assessed using pre- and post-dialysis blood urea nitrogen (BUN) levels. Kt/V will be calculated to evaluate the effectiveness of hemodialysis treatment. Higher values indicate better dialysis efficiency.

  4. Dialysis Adequacy - Urea Reduction Ratio

    Time frame: Baseline and after 12 weeks

    Dialysis adequacy will be assessed using pre- and post-dialysis blood urea nitrogen (BUN) levels. Urea Reduction Ratio (URR) will be calculated to evaluate the effectiveness of hemodialysis treatment. Higher values indicate better dialysis efficiency.

Secondary outcomes

  1. Handgrip Strength

    Time frame: Baseline

    Grip strength will be measured using a Jamar dynamometer according to American Society of Hand Therapists' standard procedures. Three attempts will be recorded for both dominant and non-dominant hands, and the maximum value (kg) will be used.

  2. Fat-Free Mass Index

    Time frame: Baseline

    Fat-free mass index (FFMI, kg/m²) will be assessed by Bioelectrical Impedance Analysis (BIA).

  3. Peripheral Muscle Strength

    Time frame: Baseline and after 12 weeks

    Muscle strength of major upper and lower limb groups will be assessed using a digital dynamometer. Upper limb measurements (shoulder and elbow flexors) will be performed on the non-fistula arm, while lower limb measurements (hip flexors and knee extensors) will be performed bilaterally.

  4. Six-Minute Walk Test (6MWT)

    Time frame: Baseline and after 12 weeks

    Muscle oxygenation measurements will be taken at rest, during a 6-minute walk test (6MWT), and during recovery. The 6MWT will serve solely as a standardized protocol for eliciting muscle activity during NIRS monitoring, not as an independent functional outcome.

  5. Short Physical Performance Battery (SPPB)

    Time frame: Baseline and after 12 weeks

    Physical performance will be assessed by SPPB, including sit-to-stand test, balance tests, and gait speed. Scores range from 0-12, with lower scores indicating poorer performance.

  6. Fatigue Severity Scale (FSS)

    Time frame: Baseline and after 12 weeks

    Patient-reported fatigue will be assessed using the FSS, a 9-item Likert-type questionnaire. Higher mean scores indicate greater fatigue severity.

  7. Kidney Disease Quality of Life (KDQOL-36)

    Time frame: Baseline and after 12 weeks

    Health-related quality of life will be measured with the KDQOL-36, covering symptom burden, effects and burden of kidney disease, and physical/mental health components. Higher scores reflect better quality of life.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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