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

NCT07427264 | Active Not Recruiting

• 1 other identifier: 121/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemodialysis; Intradialytic Exercise; Chronic Kidney Disease; Functional Capacity

Outcome Measures

Primary Outcomes (26)

• Clinical and demographic characteristics

  Baseline

• Clinical and demographic characteristics

  6-month

• Muscle oxygenation Assessment-MOXY

  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).

  Baseline

• Muscle oxygenation Assessment-MOXY

  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).

  6-month

• Body composition analysis

  Bioelectrical impedance analysis (Bodystat QuadScan 4000).

  Baseline

• Body composition analysis

  Bioelectrical impedance analysis (Bodystat QuadScan 4000).

  6-month

• Six minute walk test

  Aerobic capacity

  Baseline

• Six minute walk test

  Aerobic capacity

  6-month

• JAMAR SMART Hand Dynamometer

  Handgrip Strength

  Baseline

• JAMAR SMART Hand Dynamometer

  Handgrip Strength

  6- month

• 30-second Sit-to-Stand Test

  Lower limb functional capacity

  Baseline

• 30-second Sit-to-Stand Test

  Lower limb functional capacity

  6- month

• Five-Repetition Sit-to-Stand Test (5STS)

  Lower limb functional capacity

  Baseline

• Five-Repetition Sit-to-Stand Test (5STS)

  Lower limb functional capacity

  6- month

• 4-Meter Gait Speed Test

  Baseline

• 4-Meter Gait Speed Test

  6- month

• International Physical Activity Questionnaire (IPAQ).

  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.

  Baseline

• International Physical Activity Questionnaire (IPAQ).

  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.

  6- month

• Beck Depression Inventory (BDI)

  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).

  Baseline

• Beck Depression Inventory (BDI)

  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).

  6- month

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

  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.

  Baseline

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

  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.

  6- month

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

  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.

  Baseline

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

  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.

  6- month

• Baseline leg dynamometer

  Baseline

• Baseline leg dynamometer

  6- month

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise Group, 6- month combined aerobic and strength exercise

Other: EXERCISE INTERVENTION

Usual care

NO INTERVENTION

Control Group, 6- month without participating in organized exercise activities, no intervention

Interventions

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \<80 years, either gender
• Confirmed diagnosis
• Patients undergoing maintenance hemodialysis therapy for at least 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Sports Medicine Laboratory, Aristotle University of Thessaloniki

Thessaloniki, 57001, Greece

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Evangelia Kouidi, Professor

  Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Sports Medicine

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: June 27, 2025
• Primary Completion: January 27, 2026
• Study Completion: April 7, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

GR (1)