Supportive CareEXCOG-HDNCT07780175
Intradialytic Exercise and Cognitive Function
A study testing Resistance Training, Aerobic training and Combination Training in people with Supportive Care and Exercise Adaptations, run by University of Thessaly at 1 site in Cyprus.
Trial summary
Exercise training may improve global and domain-specific cognitive function, mental health, psychological well-being, dialysis efficacy, and health-related quality of life in people with end-stage kidney disease receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supportive Care, Exercise Adaptations, Exercise Training Therapy
- What is being tested?
- Resistance Training, Aerobic training and Combination Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent.
- Chronic kidney disease stage 5 / end-stage kidney disease.
- Established on maintenance hemodialysis for at least 3 months.
Who cannot join
- Newly established on hemodialysis for less than 3 months.
- Terminal illness with life expectancy shorter than the 6-month intervention/follow-up period.
- Clinically unstable condition as determined by the treating clinical team.
- Diagnosis of dementia, Alzheimer disease, or severe cognitive dysfunction, defined as a Mini-Mental State Examination score below 17 points.
- Pregnancy at baseline or at any point during the intervention.
- Physical complication or limitation that prevents safe participation in exercise training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Long-Term Hybrid Intradialytic Exercise on Cognitive Function and Quality of Life in End-Stage Kidney Disease Patients: A Randomized Controlled Trial
Exercise training may improve global and domain-specific cognitive function, mental health, psychological well-being, dialysis efficacy, and health-related quality of life in people with end-stage kidney disease receiving hemodialysis. Intradialytic exercise is considered feasible, safe, and effective in this population. This randomized controlled trial will compare standard care alone with three intradialytic exercise modalities--resistance training, aerobic training, and combined hybrid training--to examine short- and longer-term effects on cognitive function and quality of life in hemodialysis patients.
Read the detailed description
This is a four-arm, randomized, controlled, parallel-group trial in adults with chronic kidney disease stage 5 receiving maintenance hemodialysis. Eligible participants will be randomly allocated to one of four conditions: (1) standard care only; (2) intradialytic resistance exercise training in addition to standard care; (3) intradialytic aerobic exercise training in addition to standard care; or (4) intradialytic hybrid exercise training, consisting of aerobic and resistance exercise in succession, in addition to standard care. The exercise interventions will be delivered during routine dialysis sessions three times per week for 24 weeks.
All baseline and follow-up measurements will be conducted at the same clinic, on the same dialysis weekday and time where possible, and under standardized conditions. Assessments will be performed at baseline, 3 months, and 6 months. The study has been approved by the Cyprus National Bioethics Committee (approval number: EEBK/ΕΠ/2024/10), and all participants will provide written informed consent before participation.
Body composition will be evaluated using anthropometric measures, including body mass index, and bioimpedance analysis using standardized methods. Physical function and aerobic capacity will be evaluated using handgrip strength, the timed-up and go test, 5-repetition sit-to-stand, 30-second and 60-second sit-to-stand tests, the 6-minute walk test, and maximal oxygen uptake using a portable metabolic system. Free-living physical activity will be objectively assessed by accelerometry. Vital signs, including heart rate, oxygen saturation, and blood pressure, will be recorded using automated techniques. Clinical measures, including circulating microRNA expression and gut microbiota composition, will be assessed using blood and stool samples with standardized methods.
Cognitive function will be assessed with the Mini-Mental State Examination and the Trail Making Test Parts A and B. Health-related quality of life will be assessed with the 36-Item Short Form Survey. Habitual physical activity will be assessed with the International Physical Activity Questionnaire. Restless leg symptom severity, sleep quality, daytime sleepiness, fatigue severity, and depression severity will be assessed with validated questionnaires, including the International Restless Legs Syndrome Study Group questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Fatigue Severity Scale, and Beck Depression Inventory. Detailed health history and treatment characteristics will be obtained from electronic health records by participating nephrologists.
Statistical analysis will be performed using IBM SPSS Statistics version 29. Baseline characteristics of the four groups will be compared using appropriate between-group tests. A two-way repeated-measures analysis of variance will be used to examine time-by-group effects of the intervention on the examined parameters. Absolute changes from baseline to 3-month and 6-month follow-up will be compared between groups. Statistical significance will be set at p <= 0.05. Data will be presented as mean +/- standard deviation unless otherwise specified.
- Being tested
- Resistance Training, Aerobic training, Combination Training
- Keywords
- intradialytic exercise, aerobic exercise, resistance exercise, hybrid exercise, cognitive function, hemodialysis, quality of life, ESRD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Dialysis patients will receive resistance exercise training during dialysis
Aerobic trainingBehavioural
Dialysis patients will receive aerobic exercise training during dialysis
Combination TrainingBehavioural
Dialysis patients will receive both aerobic and resistance exercise training during dialysis
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive no intervention |
| Exercise - Resistance Bands | Experimental | Participants will receive intradialytic resistance exercise training during standard dialysis treatment. Receives: Behavioral: Resistance Training |
| Exercise - Recumbent Cycling | Experimental | Participants will receive intradialytic aerobic exercise training using a recumbent cycle during standard dialysis treatment. Receives: Behavioral: Aerobic training |
| Exercise - Combination training | Experimental | Participants will receive both intradialytic aerobic and resistance exercise training in succession during standard dialysis treatment. Receives: Behavioral: Combination Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function
Change in global cognitive function assessed by the Mini-Mental State Examination (MMSE) - Global cognitive function will be assessed with the Mini-Mental State Examination. The MMSE is scored from 0 to 30, with higher scores indicating better global cognition and lower scores suggesting cognitive impairment. Change from baseline will be evaluated at 3 months and 6 months.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (6)
Functional Capacity
Changes in Functional capacity. These include test such as, maximal isometric grip strength (Kg)
Measured: Baseline, 3 months, and 6 months
Body Composition
Body composition will be assessed using bioelectrical impedance analysis (BIA), following the manufacturer's instructions and a standardized measurement protocol. Assessments will be performed by trained personnel using the same device at each visit. Participants will be measured barefoot and in light clothing, under comparable hydration and fasting conditions, after emptying their bladder and avoiding strenuous exercise and alcohol before testing. Where feasible, measurements will be conducted at approximately the same time of day. Body fat percentage, fat mass, fat-free mass, and other device-derived body-composition parameters will be recorded. Absolute and percentage changes from baseline will be evaluated at 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Health-related quality of life
Health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Change from baseline will be evaluated at 3 months and 6 months.
Measured: Baseline, 3 months, and 6 months
Frailty score
Frailty will be assessed using the Fried Frailty Phenotype. Scores range from 0 to 5, with higher scores indicating greater frailty. Change from baseline will be evaluated at 3 months and 6 months.
Measured: Baseline, 3 months, and 6 months
Plasma microRNA expression
Expression levels of specific microRNAs in blood plasma will be determined using standardized laboratory methods. Change from baseline will be evaluated at 3 months and 6 months.
Measured: Baseline, 3 months, and 6 months
Gut microbiota composition
Composition, diversity, and functional profile of gut microbiota in stool samples will be determined using standardized methods. Change from baseline will be evaluated at 3 months and 6 months.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supportive CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm, randomized, controlled, parallel-group trial comparing standard care alone with three intradialytic exercise programs: resistance exercise, aerobic exercise, and hybrid exercise. Participants are followed for 6 months, with exercise delivered three times weekly for 24 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nicosia, University of Cyprus
- Responsible party
- Principal investigator, Giorgos K. Sakkas, University of Thessaly
- Investigators
- Christoforos D. Giannaki, PhD, Principal investigator, University of NicosiaGeorgios M. Hadjigeorgiou, MD, PhD, Study chair, University of CyprusNicos Mitsides, MD, PhD, Study director, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780175
- Sponsor's protocol ID
- AM170426
- Acronym
- EXCOG-HD
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared because no approved data-sharing plan is currently in place.
Publications
Rosa CSC, Giannaki CD, Krase A, Mplekou M, Grigoriou SS, Stefanidis I, Lavdas E, Pappas A, Bloxham S, Karatzaferi C, Sakkas GK. Effects of 12 months of detraining on health-related quality of life in patients receiving hemodialysis therapy. Int Urol Nephrol. 2020 Sep;52(9):1771-1778. doi: 10.1007/s11255-020-02560-5. Epub 2020 Aug 14.
PubMed 32797383Grigoriou SS, Karatzaferi C, Giannaki CD, Patramani G, Vogiatzi C, Mitrou GI, Stefanidis I, Sakkas GK. The effect of a 9-month hybrid intradialytic exercise training program on nerve conduction velocity parameters in patients receiving hemodialysis therapy. Int Urol Nephrol. 2022 Dec;54(12):3271-3281. doi: 10.1007/s11255-022-03266-6. Epub 2022 Jul 5.
PubMed 35789452Giannaki CD, Grigoriou SS, George K, Karatzaferi C, Zigoulis P, Lavdas E, Chaniotis D, Stefanidis I, Sakkas GK. Nine Months of Hybrid Intradialytic Exercise Training Improves Ejection Fraction and Cardiac Autonomic Nervous System Activity. Sports (Basel). 2023 Mar 31;11(4):79. doi: 10.3390/sports11040079.
PubMed 37104153Mavrommatis A, Mitsides N, Pieri M, Andreou EP, Sakkas GK, Dimitriou K, Spartalis M, Arsali M, Christofi T, Theophanous T, Wollesen B, Hadjigeorgiou GM, Giannaki CD. The Effect of Intradialytic Exercise on Cognition in Renal Patients Undergoing Hemodialysis: An Updated Systematic Review of Randomized Controlled Trials. Healthcare (Basel). 2025 Nov 21;13(23):3016. doi: 10.3390/healthcare13233016.
PubMed 41373233
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long-Term Hybrid Intradialytic Exercise on Cognitive Function and Quality of Life in End-Stage Kidney Disease Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07780175
- Acronym / sponsor ID
- EXCOG-HD / AM170426
- Keywords
- intradialytic exercise, aerobic exercise, resistance exercise, hybrid exercise, cognitive function, hemodialysis, quality of life, ESRD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Nicosia, University of Cyprus
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 21 Aug 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.
Exercise training may improve global and domain-specific cognitive function, mental health, psychological well-being, dialysis efficacy, and health-related quality of life in people with end-stage kidney disease receiving hemodialysis. Intradialytic exercise is considered feasible, safe, and effective in this population. This randomized controlled trial will compare standard care alone with three intradialytic exercise modalities--resistance training, aerobic training, and combined hybrid training--to examine short- and longer-term effects on cognitive function and quality of life in hemodialysis patients.
Detailed description
This is a four-arm, randomized, controlled, parallel-group trial in adults with chronic kidney disease stage 5 receiving maintenance hemodialysis. Eligible participants will be randomly allocated to one of four conditions: (1) standard care only; (2) intradialytic resistance exercise training in addition to standard care; (3) intradialytic aerobic exercise training in addition to standard care; or (4) intradialytic hybrid exercise training, consisting of aerobic and resistance exercise in succession, in addition to standard care. The exercise interventions will be delivered during routine dialysis sessions three times per week for 24 weeks.
All baseline and follow-up measurements will be conducted at the same clinic, on the same dialysis weekday and time where possible, and under standardized conditions. Assessments will be performed at baseline, 3 months, and 6 months. The study has been approved by the Cyprus National Bioethics Committee (approval number: EEBK/ΕΠ/2024/10), and all participants will provide written informed consent before participation.
Body composition will be evaluated using anthropometric measures, including body mass index, and bioimpedance analysis using standardized methods. Physical function and aerobic capacity will be evaluated using handgrip strength, the timed-up and go test, 5-repetition sit-to-stand, 30-second and 60-second sit-to-stand tests, the 6-minute walk test, and maximal oxygen uptake using a portable metabolic system. Free-living physical activity will be objectively assessed by accelerometry. Vital signs, including heart rate, oxygen saturation, and blood pressure, will be recorded using automated techniques. Clinical measures, including circulating microRNA expression and gut microbiota composition, will be assessed using blood and stool samples with standardized methods.
Cognitive function will be assessed with the Mini-Mental State Examination and the Trail Making Test Parts A and B. Health-related quality of life will be assessed with the 36-Item Short Form Survey. Habitual physical activity will be assessed with the International Physical Activity Questionnaire. Restless leg symptom severity, sleep quality, daytime sleepiness, fatigue severity, and depression severity will be assessed with validated questionnaires, including the International Restless Legs Syndrome Study Group questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Fatigue Severity Scale, and Beck Depression Inventory. Detailed health history and treatment characteristics will be obtained from electronic health records by participating nephrologists.
Statistical analysis will be performed using IBM SPSS Statistics version 29. Baseline characteristics of the four groups will be compared using appropriate between-group tests. A two-way repeated-measures analysis of variance will be used to examine time-by-group effects of the intervention on the examined parameters. Absolute changes from baseline to 3-month and 6-month follow-up will be compared between groups. Statistical significance will be set at p <= 0.05. Data will be presented as mean +/- standard deviation unless otherwise specified.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm, randomized, controlled, parallel-group trial comparing standard care alone with three intradialytic exercise programs: resistance exercise, aerobic exercise, and hybrid exercise. Participants are followed for 6 months, with exercise delivered three times weekly for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive no intervention |
| Exercise - Resistance Bands | Experimental | Behavioral: Resistance TrainingParticipants will receive intradialytic resistance exercise training during standard dialysis treatment. |
| Exercise - Recumbent Cycling | Experimental | Behavioral: Aerobic trainingParticipants will receive intradialytic aerobic exercise training using a recumbent cycle during standard dialysis treatment. |
| Exercise - Combination training | Experimental | Behavioral: Combination TrainingParticipants will receive both intradialytic aerobic and resistance exercise training in succession during standard dialysis treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent.
- Chronic kidney disease stage 5 / end-stage kidney disease.
- Established on maintenance hemodialysis for at least 3 months.
Key exclusion criteria (6 listed)
- Newly established on hemodialysis for less than 3 months.
- Terminal illness with life expectancy shorter than the 6-month intervention/follow-up period.
- Clinically unstable condition as determined by the treating clinical team.
- Diagnosis of dementia, Alzheimer disease, or severe cognitive dysfunction, defined as a Mini-Mental State Examination score below 17 points.
- Pregnancy at baseline or at any point during the intervention.
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 |
|---|---|---|
| Resistance TrainingDialysis patients will receive resistance exercise training during dialysis | Behavioural | Exercise - Resistance Bands |
| Aerobic trainingDialysis patients will receive aerobic exercise training during dialysis | Behavioural | Exercise - Recumbent Cycling |
| Combination TrainingDialysis patients will receive both aerobic and resistance exercise training during dialysis | Behavioural | Exercise - Combination training |
Primary outcome
Global cognitive function
Time frame: Baseline, 3 months, and 6 months
Change in global cognitive function assessed by the Mini-Mental State Examination (MMSE) - Global cognitive function will be assessed with the Mini-Mental State Examination. The MMSE is scored from 0 to 30, with higher scores indicating better global cognition and lower scores suggesting cognitive impairment. Change from baseline will be evaluated at 3 months and 6 months.
6 secondary outcomes
Functional Capacity
Time frame: Baseline, 3 months, and 6 months
Body Composition
Time frame: Baseline, 3 months, and 6 months
Health-related quality of life
Time frame: Baseline, 3 months, and 6 months
Frailty score
Time frame: Baseline, 3 months, and 6 months
Plasma microRNA expression
Time frame: Baseline, 3 months, and 6 months
Gut microbiota composition
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 32797383Rosa CSC, Giannaki CD, Krase A, Mplekou M, Grigoriou SS, Stefanidis I, Lavdas E, Pappas A, Bloxham S, Karatzaferi C, Sakkas GK. Effects of 12 months of detraining on health-related quality of life in patients receiving hemodialysis therapy. Int Urol Nephrol. 2020 Sep;52(9):1771-1778. doi: 10.1007/s11255-020-02560-5. Epub 2020 Aug 14.
- Background: PubMed 35789452Grigoriou SS, Karatzaferi C, Giannaki CD, Patramani G, Vogiatzi C, Mitrou GI, Stefanidis I, Sakkas GK. The effect of a 9-month hybrid intradialytic exercise training program on nerve conduction velocity parameters in patients receiving hemodialysis therapy. Int Urol Nephrol. 2022 Dec;54(12):3271-3281. doi: 10.1007/s11255-022-03266-6. Epub 2022 Jul 5.
- Background: PubMed 37104153Giannaki CD, Grigoriou SS, George K, Karatzaferi C, Zigoulis P, Lavdas E, Chaniotis D, Stefanidis I, Sakkas GK. Nine Months of Hybrid Intradialytic Exercise Training Improves Ejection Fraction and Cardiac Autonomic Nervous System Activity. Sports (Basel). 2023 Mar 31;11(4):79. doi: 10.3390/sports11040079.
- Background: PubMed 41373233Mavrommatis A, Mitsides N, Pieri M, Andreou EP, Sakkas GK, Dimitriou K, Spartalis M, Arsali M, Christofi T, Theophanous T, Wollesen B, Hadjigeorgiou GM, Giannaki CD. The Effect of Intradialytic Exercise on Cognition in Renal Patients Undergoing Hemodialysis: An Updated Systematic Review of Randomized Controlled Trials. Healthcare (Basel). 2025 Nov 21;13(23):3016. doi: 10.3390/healthcare13233016.
- Individual participant dataSharing planned: No. No individual participant data will be shared because no approved data-sharing plan is currently in place.
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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.
Christoforos D. Giannaki, PhD principal investigator
University of Nicosia
Georgios M. Hadjigeorgiou, MD, PhD study chair
University of Cyprus
Nicos Mitsides, MD, PhD study director
University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training, Aerobic training and Combination Training in people with Supportive Care and Exercise Adaptations, run by University of Thessaly at 1 site in Cyprus.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 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 Cyprus. 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?
This study is still under way. Results are not available in the source record yet.
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?
Global cognitive function (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07780175, which also lists 4 linked publications.
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 21 Aug 2026.