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NCT Number: NCT07427264

The Effect of a Mixed-type Intradialytic Exercise Training Program on Body Composition, Functional Capacity, and Muscle Oxygenation of the Upper and Lower Limbs in Hemodialysis Patients

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.

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Key information

Conditions

Haemodialysis Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Functional Capacity Intradialytic Exercise Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, 57001, Greece

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise intervention

Other

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.

Primary outcomes

  1. Clinical and demographic characteristics

    Time frame: Baseline

  2. Clinical and demographic characteristics

    Time frame: 6-month

  3. Muscle oxygenation Assessment-MOXY

    Time frame: Baseline

    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).

  4. Muscle oxygenation Assessment-MOXY

    Time frame: 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).

  5. Body composition analysis

    Time frame: Baseline

    Bioelectrical impedance analysis (Bodystat QuadScan 4000).

  6. Body composition analysis

    Time frame: 6-month

    Bioelectrical impedance analysis (Bodystat QuadScan 4000).

  7. Six minute walk test

    Time frame: Baseline

    Aerobic capacity

  8. Six minute walk test

    Time frame: 6-month

    Aerobic capacity

  9. JAMAR SMART Hand Dynamometer

    Time frame: Baseline

    Handgrip Strength

  10. JAMAR SMART Hand Dynamometer

    Time frame: 6- month

    Handgrip Strength

  11. 30-second Sit-to-Stand Test

    Time frame: Baseline

    Lower limb functional capacity

  12. 30-second Sit-to-Stand Test

    Time frame: 6- month

    Lower limb functional capacity

  13. Five-Repetition Sit-to-Stand Test (5STS)

    Time frame: Baseline

    Lower limb functional capacity

  14. Five-Repetition Sit-to-Stand Test (5STS)

    Time frame: 6- month

    Lower limb functional capacity

  15. 4-Meter Gait Speed Test

    Time frame: Baseline

  16. 4-Meter Gait Speed Test

    Time frame: 6- month

  17. International Physical Activity Questionnaire (IPAQ).

    Time frame: 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.

  18. International Physical Activity Questionnaire (IPAQ).

    Time frame: 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.

  19. Beck Depression Inventory (BDI)

    Time frame: 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).

  20. Beck Depression Inventory (BDI)

    Time frame: 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).

  21. Generalized Anxiety Disorder-7 scale (GAD-7).

    Time frame: 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.

  22. Generalized Anxiety Disorder-7 scale (GAD-7).

    Time frame: 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.

  23. Kidney Disease Quality of Life Short Form (KDQOL-SF™)

    Time frame: 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.

  24. Kidney Disease Quality of Life Short Form (KDQOL-SF™)

    Time frame: 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.

  25. Baseline leg dynamometer

    Time frame: Baseline

  26. Baseline leg dynamometer

    Time frame: 6- month

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Mar 2, 2026

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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