HemodialysisNCT07390656
Intradialytic Resistance and Flexibility Exercise in Hemodialysis Patients
A study testing Resistance Exercise and Flexibility Exercise in people with Hemodialysis, run by Dilek GİBYELİ GENEK at 1 site in Turkey (Türkiye).
Trial summary
This study examined whether different types of exercise performed during hemodialysis sessions affect patients' health and quality of life. Patients receiving regular hemodialysis were assigned to resistance exercise, flexibility exercise, or usual care during dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Resistance Exercise and Flexibility Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Receiving maintenance hemodialysis for at least 3 months
- Stable clinical condition
- Ability to participate in exercise during hemodialysis sessions
- Provided written informed consent
Who cannot join
- Acute illness or unstable cardiovascular disease
- Severe musculoskeletal or neurological conditions limiting exercise
- Recent hospitalization
- Cognitive impairment preventing cooperation
- Participation in another structured exercise program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University Training and Research Hospital
Muğla, Muğla, 48000
About this study
Official title: Effects of Intradialytic Resistance and Flexibility Exercises on Clinical Outcomes in Hemodialysis Patients: A Pilot Randomized Controlled Trial
This study examined whether different types of exercise performed during hemodialysis sessions affect patients' health and quality of life. Patients receiving regular hemodialysis were assigned to resistance exercise, flexibility exercise, or usual care during dialysis. Changes in health-related outcomes were evaluated before and after the exercise period.
Read the detailed description
This single-center pilot study was conducted to explore the effects of exercise performed during hemodialysis on patients' health. Adult patients undergoing maintenance hemodialysis participated in one of three groups: resistance exercise, flexibility exercise, or usual care without exercise. The exercise programs were carried out during routine dialysis sessions under supervision.
Patients' clinical measurements and self-reported health outcomes were assessed at the start of the study and again after completion of the exercise period. The study was carried out between December 2020 and April 2021 following approval by the institutional ethics committee.
- Conditions
- Hemodialysis
- Being tested
- Resistance Exercise, Flexibility Exercise
- Keywords
- Intradialytic exercise, Resistance exercise, Flexibility exercise, Quality of life, Clinical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
A structured resistance exercise program performed during routine hemodialysis sessions under supervision.
Flexibility ExerciseBehavioural
A structured flexibility and stretching exercise program performed during routine hemodialysis sessions under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Experimental | Participants performed supervised resistance exercise during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period. Receives: Behavioral: Resistance Exercise |
| Flexibility Exercise | Experimental | Participants performed supervised flexibility and stretching exercises during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period. Receives: Behavioral: Flexibility Exercise |
| Usual Care (Control) | No intervention | Participants received usual hemodialysis care without any structured exercise program during dialysis sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dialysis adequacy assessed by Kt/V (urea)
Change in dialysis adequacy measured by single-pool Kt/V (urea).
Measured: From baseline to 12 weeks
Change in dialysis adequacy assessed by urea reduction ratio (URR)
Change in dialysis adequacy measured by urea reduction ratio (URR), expressed as a percentage
Measured: From baseline to 12 weeks
Secondary outcomes (6)
Change in Short Form-36 (SF-36) Health-Related Quality of Life score
Change in health-related quality of life assessed using the Short Form-36 Health Survey (SF-36), a validated 36-item questionnaire.
SF-36 domain scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: From baseline to 12 weeks
Change in Beck Depression Inventory score
Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Measured: From baseline to 12 weeks
Change in body mass index (BMI)
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m^2). Higher BMI indicates greater body mass relative to height.
Measured: From baseline to 12 weeks
Change in fat tissue index (FTI)
Change in fat tissue index (FTI) assessed by bioelectrical impedance analysis (BIA), calculated from fat tissue mass (FTM) normalized to height squared (kg/m^2).
Measured: From baseline to 12 weeks
Change in lean tissue index (LTI)
Change in lean tissue index (LTI) assessed by bioelectrical impedance analysis (BIA), calculated from lean tissue mass normalized to height squared (kg/m^2).
Measured: From baseline to 12 weeks
Change in physical function assessed by the 6-minute walk test (6MWT)
Change in physical function assessed using the 6-minute walk test (6MWT), measured as the total distance walked in meters.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jan 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Model description
- Participants were assigned to resistance exercise, flexibility exercise, or usual care groups and followed in parallel during the study period.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek GİBYELİ GENEK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek GİBYELİ GENEK, Muğla Sıtkı Koçman University
- Investigators
- Dilek Gibyeli Genek, MD, Principal investigator, Muğla Sıtkı Koçman University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390656
- Sponsor's protocol ID
- HD-EX-2020
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data from this study.
Publications
Genek DG, Arikan II, Gazezoglu OU, Alp A, Huddam B. Effects of intradialytic resistance versus flexibility exercises on clinical outcomes in hemodialysis patients: a pilot randomized controlled trial. BMC Nephrol. 2026 Jun 8. doi: 10.1186/s12882-026-05094-7. Online ahead of print.
PubMed 42252421
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Resistance and Flexibility Exercises on Clinical Outcomes in Hemodialysis Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07390656
- Acronym / sponsor ID
- HD-EX-2020
- Conditions
- Hemodialysis
- Keywords
- Intradialytic exercise, Resistance exercise, Flexibility exercise, Quality of life, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dilek GİBYELİ GENEKUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 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.
This study examined whether different types of exercise performed during hemodialysis sessions affect patients' health and quality of life. Patients receiving regular hemodialysis were assigned to resistance exercise, flexibility exercise, or usual care during dialysis. Changes in health-related outcomes were evaluated before and after the exercise period.
Detailed description
This single-center pilot study was conducted to explore the effects of exercise performed during hemodialysis on patients' health. Adult patients undergoing maintenance hemodialysis participated in one of three groups: resistance exercise, flexibility exercise, or usual care without exercise. The exercise programs were carried out during routine dialysis sessions under supervision.
Patients' clinical measurements and self-reported health outcomes were assessed at the start of the study and again after completion of the exercise period. The study was carried out between December 2020 and April 2021 following approval by the institutional ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were assigned to resistance exercise, flexibility exercise, or usual care groups and followed in parallel during the study period.
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Experimental | Behavioral: Resistance ExerciseParticipants performed supervised resistance exercise during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period. |
| Flexibility Exercise | Experimental | Behavioral: Flexibility ExerciseParticipants performed supervised flexibility and stretching exercises during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period. |
| Usual Care (Control) | No intervention | –Participants received usual hemodialysis care without any structured exercise program during dialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Receiving maintenance hemodialysis for at least 3 months
- Stable clinical condition
- Ability to participate in exercise during hemodialysis sessions
- Provided written informed consent
Key exclusion criteria (5 listed)
- Acute illness or unstable cardiovascular disease
- Severe musculoskeletal or neurological conditions limiting exercise
- Recent hospitalization
- Cognitive impairment preventing cooperation
- Participation in another structured exercise program
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 ExerciseA structured resistance exercise program performed during routine hemodialysis sessions under supervision. | Behavioural | Resistance Exercise |
| Flexibility ExerciseA structured flexibility and stretching exercise program performed during routine hemodialysis sessions under supervision. | Behavioural | Flexibility Exercise |
Primary outcome
Change in dialysis adequacy assessed by Kt/V (urea)
Time frame: From baseline to 12 weeks
Change in dialysis adequacy measured by single-pool Kt/V (urea).
Change in dialysis adequacy assessed by urea reduction ratio (URR)
Time frame: From baseline to 12 weeks
Change in dialysis adequacy measured by urea reduction ratio (URR), expressed as a percentage
6 secondary outcomes
Change in Short Form-36 (SF-36) Health-Related Quality of Life score
Time frame: From baseline to 12 weeks
Change in Beck Depression Inventory score
Time frame: From baseline to 12 weeks
Change in body mass index (BMI)
Time frame: From baseline to 12 weeks
Change in fat tissue index (FTI)
Time frame: From baseline to 12 weeks
Change in lean tissue index (LTI)
Time frame: From baseline to 12 weeks
Change in physical function assessed by the 6-minute walk test (6MWT)
Time frame: From baseline to 12 weeks
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 5 Feb 2026.
- Derived from this study: PubMed 42252421Genek DG, Arikan II, Gazezoglu OU, Alp A, Huddam B. Effects of intradialytic resistance versus flexibility exercises on clinical outcomes in hemodialysis patients: a pilot randomized controlled trial. BMC Nephrol. 2026 Jun 8. doi: 10.1186/s12882-026-05094-7. Online ahead of print.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data from this study.
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
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.
Dilek Gibyeli Genek, MD principal investigator
Muğla Sıtkı Koçman University, Faculty of Medicine
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 Exercise and Flexibility Exercise in people with Hemodialysis, run by Dilek GİBYELİ GENEK at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 5 Feb 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 Turkey (Türkiye). 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?
Change in dialysis adequacy assessed by Kt/V (urea) (time frame: From baseline to 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07390656, which also lists 1 linked publication.
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 5 Feb 2026.