Chronic Kidney Disease, Stage 5NCT07151742
Effects of Intradialytic Exercise on Muscle Oxygenation and Dialysis Adequacy
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease, Stage 5 and Sarcopenia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease, Stage 5, Sarcopenia
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of orthopedic or neurological disorders affecting mobility or exercise capacity
- Uncontrolled diabetes mellitus or uncontrolled hypertension
- Untreated intradialytic hypotension
- Heart failure
- Unstable angina
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kadıköy Ata Dialysis Center
Istanbul, Kadikoy, 34720
About this study
Official title: Investigation of the Effects of Intradialytic Combined Exercises on Dialysis Parameters and Muscle Oxygenation in Sarcopenic Hemodialysis Patients
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease, Stage 5, Sarcopenia
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- Hemodialysis, sarcopenia, Intradialytic exercise, muscle oxygenation, Dialysis Parameters
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
Also called intradialytic exercise
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 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 Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Control Group | No intervention | Participants in this arm will continue routine hemodialysis care for 12 weeks. In addition, they will receive general recommendations for breathing and posture exercises to be performed outside dialysis sessions. These exercises will not be structured or supervised, and no additional training program will be provided during dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Oxygen Saturation (SmO₂, %)
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.
Measured: Baseline and after 12 weeks
Total Hemoglobin Concentration
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.
Measured: Baseline and after 12 weeks
Dialysis Adequacy - Kt/V
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.
Measured: Baseline and after 12 weeks
Dialysis Adequacy - Urea Reduction Ratio
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.
Measured: Baseline and after 12 weeks
Secondary outcomes (7)
Handgrip Strength
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.
Measured: Baseline
Fat-Free Mass Index
Fat-free mass index (FFMI, kg/m²) will be assessed by Bioelectrical Impedance Analysis (BIA).
Measured: Baseline
Peripheral Muscle Strength
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.
Measured: Baseline and after 12 weeks
Six-Minute Walk Test (6MWT)
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.
Measured: Baseline and after 12 weeks
Short Physical Performance Battery (SPPB)
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.
Measured: Baseline and after 12 weeks
Fatigue Severity Scale (FSS)
Patient-reported fatigue will be assessed using the FSS, a 9-item Likert-type questionnaire. Higher mean scores indicate greater fatigue severity.
Measured: Baseline and after 12 weeks
Kidney Disease Quality of Life (KDQOL-36)
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.
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start25 May 2025
- Primary completion25 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease, Stage 5Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial with two parallel groups. A total of 40 eligible patients undergoing maintenance hemodialysis will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group (n=20), receiving a 12-week intradialytic combined exercise program, or the control group (n=20), receiving routine hemodialysis care. Randomization will be performed using a computer-generated sequence, and allocation will be parallel without masking, as the intervention cannot be blinded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza DAL KOYUNCUOĞLU, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151742
- Sponsor's protocol ID
- 2025-123
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because data sharing was not included in the informed consent process.
Publications
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.
PubMed 34654871Umakanthan 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.
PubMed 34579163Shen 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.
PubMed 38868327Shahar 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.
PubMed 24143082Savaş, 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.
PubMed 35892024Sabatino 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.
PubMed 32876940Pipili 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.
PubMed 26089698Pender D, McGowan E, McVeigh JG, McCullagh R. The Effects of Intradialytic Exercise on Key Indices of Sarcopenia in Patients With End-stage Renal Disease: A Systematic Review of Randomized Controlled Trials. Arch Rehabil Res Clin Transl. 2023 Jan 13;5(1):100252. doi: 10.1016/j.arrct.2022.100252. eCollection 2023 Mar.
PubMed 36968168Moriyama Y, Hara M, Aratani S, Ishikawa H, Kono K, Tamaki M. The association between six month intra-dialytic resistance training and muscle strength or physical performance in patients with maintenance hemodialysis: a multicenter retrospective observational study. BMC Nephrol. 2019 May 16;20(1):172. doi: 10.1186/s12882-019-1375-1.
PubMed 31096932McManus CJ, Collison J, Cooper CE. Performance comparison of the MOXY and PortaMon near-infrared spectroscopy muscle oximeters at rest and during exercise. J Biomed Opt. 2018 Jan;23(1):1-14. doi: 10.1117/1.JBO.23.1.015007.
PubMed 29368457Krase AA, Terzis G, Giannaki CD, Stasinaki AN, Wilkinson TJ, Smith AC, Zorz C, Karatzaferi C, Stefanidis I, Sakkas GK. Seven months of aerobic intradialytic exercise training can prevent muscle loss in haemodialysis patients: an ultrasonography study. Int Urol Nephrol. 2022 Feb;54(2):447-456. doi: 10.1007/s11255-021-02931-6. Epub 2021 Jun 28.
PubMed 34184202Hu H, Wu C, Kwok JYY, Ho MH, Chau PH, Lok KYW, Choi EPH. Effects of Different Exercises on Physical Function, Dialysis Adequacy, and Health-Related Quality of Life in Maintenance Hemodialysis Patients: A Systematic Review and Network Meta-Analysis. Am J Nephrol. 2023;54(9-10):379-390. doi: 10.1159/000532109. Epub 2023 Aug 3.
PubMed 37536298Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Almushayt SJ, Hussain S, Wilkinson DJ, Selby NM. A Systematic Review of the Acute Effects of Hemodialysis on Skeletal Muscle Perfusion, Metabolism, and Function. Kidney Int Rep. 2019 Dec 30;5(3):307-317. doi: 10.1016/j.ekir.2019.12.012. eCollection 2020 Mar.
PubMed 32154452
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Intradialytic Combined Exercises on Dialysis Parameters and Muscle Oxygenation in Sarcopenic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07151742
- Acronym / sponsor ID
- 2025-123
- Conditions
- Chronic Kidney Disease, Stage 5, Sarcopenia
- Keywords
- Hemodialysis, sarcopenia, Intradialytic exercise, muscle oxygenation, Dialysis Parameters
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial with two parallel groups. A total of 40 eligible patients undergoing maintenance hemodialysis will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group (n=20), receiving a 12-week intradialytic combined exercise program, or the control group (n=20), receiving routine hemodialysis care. Randomization will be performed using a computer-generated sequence, and allocation will be parallel without masking, as the intervention cannot be blinded.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONParticipants 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 |
| Control Group | No intervention | –Participants in this arm will continue routine hemodialysis care for 12 weeks. In addition, they will receive general recommendations for breathing and posture exercises to be performed outside dialysis sessions. These exercises will not be structured or supervised, and no additional training program will be provided during dialysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Presence of orthopedic or neurological disorders affecting mobility or exercise capacity
- Uncontrolled diabetes mellitus or uncontrolled hypertension
- Untreated intradialytic hypotension
- Heart failure
- Unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: intradialytic exerciseParticipants 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 | Exercise Group |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Handgrip Strength
Time frame: Baseline
Fat-Free Mass Index
Time frame: Baseline
Peripheral Muscle Strength
Time frame: Baseline and after 12 weeks
Six-Minute Walk Test (6MWT)
Time frame: Baseline and after 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: Baseline and after 12 weeks
Fatigue Severity Scale (FSS)
Time frame: Baseline and after 12 weeks
Kidney Disease Quality of Life (KDQOL-36)
Time frame: Baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 34654871Yu 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.
- Results publication: PubMed 34579163Umakanthan 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.
- Results publication: PubMed 38868327Shen 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.
- Results publication: PubMed 24143082Shahar 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.
- Results publicationSavaş, S. (2015). Sarkopeniden korunma. Ege Tıp Dergisi, 54(0), 29-36. https://doi.org/10.19161/etd.344148
- Results publication: PubMed 35892024Sanchez-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.
- Results publication: PubMed 32876940Sabatino 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.
- Results publication: PubMed 26089698Pipili 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.
- Results publication: PubMed 36968168Pender D, McGowan E, McVeigh JG, McCullagh R. The Effects of Intradialytic Exercise on Key Indices of Sarcopenia in Patients With End-stage Renal Disease: A Systematic Review of Randomized Controlled Trials. Arch Rehabil Res Clin Transl. 2023 Jan 13;5(1):100252. doi: 10.1016/j.arrct.2022.100252. eCollection 2023 Mar.
- Results publication: PubMed 31096932Moriyama Y, Hara M, Aratani S, Ishikawa H, Kono K, Tamaki M. The association between six month intra-dialytic resistance training and muscle strength or physical performance in patients with maintenance hemodialysis: a multicenter retrospective observational study. BMC Nephrol. 2019 May 16;20(1):172. doi: 10.1186/s12882-019-1375-1.
- Results publication: PubMed 29368457McManus CJ, Collison J, Cooper CE. Performance comparison of the MOXY and PortaMon near-infrared spectroscopy muscle oximeters at rest and during exercise. J Biomed Opt. 2018 Jan;23(1):1-14. doi: 10.1117/1.JBO.23.1.015007.
- Results publication: PubMed 34184202Krase AA, Terzis G, Giannaki CD, Stasinaki AN, Wilkinson TJ, Smith AC, Zorz C, Karatzaferi C, Stefanidis I, Sakkas GK. Seven months of aerobic intradialytic exercise training can prevent muscle loss in haemodialysis patients: an ultrasonography study. Int Urol Nephrol. 2022 Feb;54(2):447-456. doi: 10.1007/s11255-021-02931-6. Epub 2021 Jun 28.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because data sharing was not included in the informed consent process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease, Stage 5 and Sarcopenia, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Oxygen Saturation (SmO₂, %) (time frame: Baseline and after 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151742, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.