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NCT07427264Completed

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
17 Feb 2026
Start date
27 Jun 2025
Primary completion date
27 Jan 2026
Lead sponsor
Aristotle University Of Thessaloniki
NCT number
NCT07427264

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 27 Jun 2025 to the primary completion date, 27 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Acute myocardial infraction
  • Severe valvular disease
  • Potentially malignant arrhythmias
  • Unstable angina
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Cognitive or psychiatric disorders

Other

  • Hospitalized patients
  • Neurological, or orthopedic limitations/non-ambulant status
  • Poor regulation of comorbidities
  • Already participating in organized exercise programs
  • Current pregnancy
  • Inability/unwillingness to give informed consent

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sports Medicine Laboratory, Aristotle University of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.