Hemodialysis PatientsNCT07758244
The Effects of Intradialytic Aerobic Exercise on Clinical Parameters, Coping With Illness, Perceived Benefits of Exercise and Barriers to Exercise in Haemodialysis Patients: A Randomised Controlled Trial
A study testing Exercise in people with Hemodialysis Patients, run by Muş Alparslan University.
Trial summary
This randomized controlled trial aims to investigate the effects of an 8-week intradialytic aerobic exercise program on clinical parameters, disease adaptation, and perceived exercise benefits and barriers in patients undergoing maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2026to 23 Oct 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having received hemodialysis treatment for 4 hours a day, 3 days a week, for at least 3 months.
Who cannot join
- Having a history of myocardial infarction within the last 3 months
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems to the extent that one cannot complete the required tests
- Being pregnant or undergoing infertility treatment
- Having a psychiatric diagnosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECTS OF INTRADİALYTİC AEROBİC EXERCİSE ON CLİNİCAL PARAMETERS, COPİNG WİTH ILLNESS, PERCEİVED BENEFİTS OF EXERCİSE AND BARRİERS TO EXERCİSE İN HAEMODİALYSİS PATİENTS: A RANDOMİSED CONTROLLED TRİAL
This randomized controlled trial aims to investigate the effects of an 8-week intradialytic aerobic exercise program on clinical parameters, disease adaptation, and perceived exercise benefits and barriers in patients undergoing maintenance hemodialysis. Eligible participants will be randomly assigned to either an intervention group receiving supervised aerobic exercise during hemodialysis sessions or a control group receiving routine hemodialysis care. Aerobic exercise will be performed three times per week during hemodialysis for eight weeks. Exercise intensity will be individually adjusted according to the participant's subjective fatigue level using the 20-point Borg Rating of Perceived Exertion (RPE) scale, targeting an intensity of 11-13 ("light to somewhat hard"). Outcomes will be assessed before and after the intervention using validated clinical measurements and patient-reported outcome measures.
- Conditions
- Hemodialysis Patients
- Being tested
- Exercise
- Keywords
- hemodialysis, aerobic exercise, adaptation to the disease, perceived exercise benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The use of intradialytic aerobic exercise in hemodialysis patients.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Active comparator | Not described Receives: Other: Exercise |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)
This is a 4-point Likert scale (1- Strongly Disagree, 4- Strongly Agree). The scale consists of 24 items and two open-ended questions. It comprises five sub-dimensions: "Daily Life (7 items)", "Exercise-related Undesirable Outcomes (7 items)", "Quality of Life (4 items)", "Exercise Effects (3 items)", and "Exercise Benefits (3 items)". The daily life and exercise-related undesirable outcomes sub-dimensions represent the obstacles to exercise, while the quality of life, exercise effects, and exercise benefits sub-dimensions represent the benefits of exercise. Items 3, 4, 6, 7, 10, 13, 16, 20, 22, and 23 comprise the benefits sub-dimension; items 1, 2, 5, 8, 9, 11, 12, 14, 15, 17-19, 21, and 24 comprise the obstacles sub-dimension. The items in the DPEBBS scale that represent barrier factors are reverse-coded. The scale is evaluated based on a total score (min=24, max=96). Higher scores indicate a greater perception of exercise benefits and fewer exercise barriers.
Measured: Two months
The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
The scale, designed to assess adherence to end-stage renal failure, consists of nine questions and four sub-dimensions encompassing adherence behaviors: "hemodialysis participation," "medication adherence," "fluid restriction adherence," and "diet adherence." The total score obtainable from the scale ranges from 0 to 1200. Higher scores indicate higher adherence to treatment.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion28 Aug 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cengiz TAŞKAYA, Study director, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758244
- Sponsor's protocol ID
- intradialytic cycling exercise
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF INTRADİALYTİC AEROBİC EXERCİSE ON CLİNİCAL PARAMETERS, COPİNG WİTH ILLNESS, PERCEİVED BENEFİTS OF EXERCİSE AND BARRİERS TO EXERCİSE İN HAEMODİALYSİS PATİENTS: A RANDOMİSED CONTROLLED TRİAL
- ClinicalTrials.gov ID
- NCT07758244
- Acronym / sponsor ID
- intradialytic cycling exercise
- Conditions
- Hemodialysis Patients
- Keywords
- hemodialysis, aerobic exercise, adaptation to the disease, perceived exercise benefits
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 11 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.
This randomized controlled trial aims to investigate the effects of an 8-week intradialytic aerobic exercise program on clinical parameters, disease adaptation, and perceived exercise benefits and barriers in patients undergoing maintenance hemodialysis. Eligible participants will be randomly assigned to either an intervention group receiving supervised aerobic exercise during hemodialysis sessions or a control group receiving routine hemodialysis care. Aerobic exercise will be performed three times per week during hemodialysis for eight weeks. Exercise intensity will be individually adjusted according to the participant's subjective fatigue level using the 20-point Borg Rating of Perceived Exertion (RPE) scale, targeting an intensity of 11-13 ("light to somewhat hard"). Outcomes will be assessed before and after the intervention using validated clinical measurements and patient-reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Active comparator | Other: Exercise |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having received hemodialysis treatment for 4 hours a day, 3 days a week, for at least 3 months.
Key exclusion criteria (5 listed)
- Having a history of myocardial infarction within the last 3 months
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems to the extent that one cannot complete the required tests
- Being pregnant or undergoing infertility treatment
- Having a psychiatric diagnosis
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 |
|---|---|---|
| ExerciseThe use of intradialytic aerobic exercise in hemodialysis patients. | Other | aerobic exercise |
Primary outcome
Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)
Time frame: Two months
This is a 4-point Likert scale (1- Strongly Disagree, 4- Strongly Agree). The scale consists of 24 items and two open-ended questions. It comprises five sub-dimensions: "Daily Life (7 items)", "Exercise-related Undesirable Outcomes (7 items)", "Quality of Life (4 items)", "Exercise Effects (3 items)", and "Exercise Benefits (3 items)". The daily life and exercise-related undesirable outcomes sub-dimensions represent the obstacles to exercise, while the quality of life, exercise effects, and exercise benefits sub-dimensions represent the benefits of exercise. Items 3, 4, 6, 7, 10, 13, 16, 20, 22, and 23 comprise the benefits sub-dimension; items 1, 2, 5, 8, 9, 11, 12, 14, 15, 17-19, 21, and 24 comprise the obstacles sub-dimension. The items in the DPEBBS scale that represent barrier factors are reverse-coded. The scale is evaluated based on a total score (min=24, max=96). Higher scores indicate a greater perception of exercise benefits and fewer exercise barriers.
The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
Time frame: Two months
The scale, designed to assess adherence to end-stage renal failure, consists of nine questions and four sub-dimensions encompassing adherence behaviors: "hemodialysis participation," "medication adherence," "fluid restriction adherence," and "diet adherence." The total score obtainable from the scale ranges from 0 to 1200. Higher scores indicate higher adherence to treatment.
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 11 Aug 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.
Cengiz TAŞKAYA study director
Muş Alparslan University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hemodialysis Patients, run by Muş Alparslan University.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Cengiz TAŞKAYA (05364811882, c.taskaya@alparslan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS) (time frame: Two months). The study lists 2 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 11 Aug 2026.