HaemodialysisNCT07427264
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
A study testing EXERCISE INTERVENTION in people with Haemodialysis and Intradialytic Exercise, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemodialysis, Intradialytic Exercise, Chronic Kidney Disease
- What is being tested?
- EXERCISE INTERVENTION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 27 Jun 2025to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and <80 years, either gender
- Confirmed diagnosis
- Patients undergoing maintenance hemodialysis therapy for at least 6 months.
Who cannot join
- Acute myocardial infraction
- Severe valvular disease
- Potentially malignant arrhythmias
- Unstable angina
- Hospitalized patients
- Uncontrolled diabetes mellitus
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Sports Medicine Laboratory, Aristotle University of Thessaloniki
Thessaloniki, 57001
About this study
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.
Read more
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.
- Being tested
- EXERCISE INTERVENTION
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE INTERVENTIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise Group, 6- month combined aerobic and strength exercise Receives: Other: EXERCISE INTERVENTION |
| Usual care | No intervention | Control Group, 6- month without participating in organized exercise activities, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and demographic characteristics
Measured: Baseline
Clinical and demographic characteristics
Measured: 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).
Measured: 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).
Measured: 6-month
Body composition analysis
Bioelectrical impedance analysis (Bodystat QuadScan 4000).
Measured: Baseline
Body composition analysis
Bioelectrical impedance analysis (Bodystat QuadScan 4000).
Measured: 6-month
Six minute walk test
Aerobic capacity
Measured: Baseline
Six minute walk test
Aerobic capacity
Measured: 6-month
JAMAR SMART Hand Dynamometer
Handgrip Strength
Measured: Baseline
JAMAR SMART Hand Dynamometer
Handgrip Strength
Measured: 6- month
30-second Sit-to-Stand Test
Lower limb functional capacity
Measured: Baseline
30-second Sit-to-Stand Test
Lower limb functional capacity
Measured: 6- month
Five-Repetition Sit-to-Stand Test (5STS)
Lower limb functional capacity
Measured: Baseline
Five-Repetition Sit-to-Stand Test (5STS)
Lower limb functional capacity
Measured: 6- month
4-Meter Gait Speed Test
Measured: Baseline
4-Meter Gait Speed Test
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6- month
Baseline leg dynamometer
Measured: Baseline
Baseline leg dynamometer
Measured: 6- month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start27 Jun 2025
- Primary completion27 Jan 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
- Investigators
- Evangelia Kouidi, Professor, Study chair, Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427264
- Sponsor's protocol ID
- 121/2022
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07427264
- Acronym / sponsor ID
- 121/2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 23 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: EXERCISE INTERVENTIONExercise Group, 6- month combined aerobic and strength exercise |
| Usual care | No intervention | –Control Group, 6- month without participating in organized exercise activities, no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and <80 years, either gender
- Confirmed diagnosis
- Patients undergoing maintenance hemodialysis therapy for at least 6 months.
Key exclusion criteria (13 listed)
- Acute myocardial infraction
- Severe valvular disease
- Potentially malignant arrhythmias
- Unstable angina
- Hospitalized patients
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 INTERVENTIONPatients 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. | Other | Exercise |
Primary outcome
Clinical and demographic characteristics
Time frame: Baseline
Clinical and demographic characteristics
Time frame: 6-month
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).
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).
Body composition analysis
Time frame: Baseline
Bioelectrical impedance analysis (Bodystat QuadScan 4000).
Body composition analysis
Time frame: 6-month
Bioelectrical impedance analysis (Bodystat QuadScan 4000).
Six minute walk test
Time frame: Baseline
Aerobic capacity
Six minute walk test
Time frame: 6-month
Aerobic capacity
JAMAR SMART Hand Dynamometer
Time frame: Baseline
Handgrip Strength
JAMAR SMART Hand Dynamometer
Time frame: 6- month
Handgrip Strength
30-second Sit-to-Stand Test
Time frame: Baseline
Lower limb functional capacity
30-second Sit-to-Stand Test
Time frame: 6- month
Lower limb functional capacity
Five-Repetition Sit-to-Stand Test (5STS)
Time frame: Baseline
Lower limb functional capacity
Five-Repetition Sit-to-Stand Test (5STS)
Time frame: 6- month
Lower limb functional capacity
4-Meter Gait Speed Test
Time frame: Baseline
4-Meter Gait Speed Test
Time frame: 6- month
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.
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.
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).
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).
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.
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.
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.
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.
Baseline leg dynamometer
Time frame: Baseline
Baseline leg dynamometer
Time frame: 6- month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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. This study is not recruiting at the moment.
Evangelia Kouidi, Professor study chair
Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece
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 INTERVENTION in people with Haemodialysis and Intradialytic Exercise, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 6 Oct 2026. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and demographic characteristics (time frame: Baseline). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.