Effects of Intradialytic Exercise on Muscle Oxygenation and Dialysis Adequacy

NCT07151742 | Enrolling By Invitation

• 1 other identifier: 2025-123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease, Stage 5; Sarcopenia

Keywords

Hemodialysis; sarcopenia; Intradialytic exercise; muscle oxygenation; Dialysis Parameters

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and after 12 weeks

Secondary Outcomes (7)

• Handgrip Strength

  Baseline

• Fat-Free Mass Index

  Baseline

• Peripheral Muscle Strength

  Baseline and after 12 weeks

• Six-Minute Walk Test (6MWT)

  Baseline and after 12 weeks

• Short Physical Performance Battery (SPPB)

  Baseline and after 12 weeks

Study Arms (2)

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

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

Interventions

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

Also known as: intradialytic exercise

Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of orthopedic or neurological disorders affecting mobility or exercise capacity
• Uncontrolled diabetes mellitus or uncontrolled hypertension
• Untreated intradialytic hypotension
• Heart failure
• Unstable angina

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Kadıköy Ata Dialysis Center

Istanbul, Kadikoy, 34720, Turkey (Türkiye)

Location

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Savaş, S. (2015). Sarkopeniden korunma. Ege Tıp Dergisi, 54(0), 29-36. https://doi.org/10.19161/etd.344148

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Pender 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.

  PMID: 36968168 BACKGROUND

• Moriyama 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.

  PMID: 31096932 BACKGROUND

• McManus 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.

  PMID: 29368457 BACKGROUND

• Krase 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.

  PMID: 34184202 BACKGROUND

• Hu 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.

  PMID: 37536298 BACKGROUND

• Cruz-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.

  PMID: 20392703 BACKGROUND

• Almushayt 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.

  PMID: 32154452 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were aware of their group assignment (exercise or routine care) due to the nature of the intervention. Neither researchers nor outcome assessors were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 3, 2025
• Study Start: May 25, 2025
• Primary Completion: November 25, 2025
• Study Completion: December 15, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)