Chronic Kidney Disease (Stages 4 and 5)NCT07442240
Intradialytic Rehabilitation and Functional Independence in Hemodialysis Patients
A study testing Dynamic Lumbar Stabilization Exercises and Respiratory Muscle Training in people with Chronic Kidney Disease (Stages 4 and 5) and Hemodialysis, run by Bandırma Onyedi Eylül University.
Trial summary
This study evaluated whether a rehabilitation program performed during hemodialysis sessions could improve daily functioning and mobility in adults receiving maintenance hemodialysis. Participants took part in either exercise-based rehabilitation, breathing muscle training, or usual care. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5), Hemodialysis
- What is being tested?
- Dynamic Lumbar Stabilization Exercises and Respiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 25 to 45 years.
- Diagnosis of chronic kidney disease undergoing maintenance hemodialysis.
- Receiving hemodialysis for at least 6 months.
- Hemodialysis schedule of three sessions per week, four hours per session.
- Clinically stable at the time of enrollment.
- Ability to participate in exercise and functional assessments.
- Provided written informed consent.
Who cannot join
- Acute medical conditions or unstable cardiovascular disease.
- Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise participation.
- Severe cognitive impairment or inability to follow instructions.
- Uncontrolled hypertension or other conditions contraindicating exercise.
- Participation in another structured exercise or rehabilitation program during the study period.
About this study
Official title: Effects of Intradialytic Dynamic Lumbar Stabilization Exercises and Inspiratory Muscle Training on Functional Independence in Patients Undergoing Maintenance Hemodialysis
This study evaluated whether a rehabilitation program performed during hemodialysis sessions could improve daily functioning and mobility in adults receiving maintenance hemodialysis. Participants took part in either exercise-based rehabilitation, breathing muscle training, or usual care. The study compared changes in functional independence and mobility before and after the rehabilitation period.
Read the detailed description
This academic clinical study was conducted in two dialysis centers in Istanbul between June 2016 and March 2017. Adults undergoing maintenance hemodialysis were allocated to one of three groups: dynamic lumbar stabilization exercises, inspiratory muscle training, or a control group receiving routine nephrological care.
Participants in the intervention groups completed a supervised intradialytic rehabilitation program three times per week for 10 weeks. Functional independence and mobility-related performance were assessed at baseline and after completion of the intervention using validated functional assessment measures. The study was conducted as part of a doctoral thesis and is being retrospectively registered for transparency.
- Being tested
- Dynamic Lumbar Stabilization Exercises, Respiratory Muscle Training
- Keywords
- intradialytic exercise, rehabilitation, inspiratory muscle training, core stabilization, functional independence, mobility
- 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.
Dynamic Lumbar Stabilization ExercisesBehavioural
A structured intradialytic exercise program focusing on trunk stabilization and neuromuscular control, performed under supervision during hemodialysis sessions.
Respiratory Muscle TrainingBehavioural
Respiratory muscle training performed during hemodialysis using threshold-based breathing exercises under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Lumbar Stabilization Exercise (DLSE) | Experimental | Participants received a supervised intradialytic dynamic lumbar stabilization exercise program three times per week for 10 weeks in addition to usual care. Receives: Behavioral: Dynamic Lumbar Stabilization Exercises |
| Respiratory Muscle Training (RMT) | Experimental | Participants received supervised respiratory muscle training during hemodialysis sessions three times per week for 10 weeks in addition to usual care. Receives: Behavioral: Respiratory Muscle Training |
| Control Group | No intervention | Participants received routine nephrological care during hemodialysis without additional exercise or rehabilitation interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
Functional exercise capacity assessed as the distance walked in six minutes, measured according to standardized procedures.
Measured: Baseline and after 10 weeks
Secondary outcomes (6)
Timed Up and Go Test (TUG)
Functional mobility assessed by the time required to stand up from a chair, walk three meters, turn, walk back, and sit down.
Measured: Baseline and after 10 weeks
Five Times Sit-to-Stand Test (5STS)
Lower extremity functional performance assessed as the time required to complete five consecutive sit-to-stand movements.
Measured: Baseline and after 10 weeks
Maximal Inspiratory Pressure (MIP)
Inspiratory muscle strength measured as maximal inspiratory pressure using standardized respiratory pressure measurement techniques.
Measured: Baseline and after 10 weeks
Maximal Expiratory Pressure (MEP)
Expiratory muscle strength measured as maximal expiratory pressure using standardized respiratory pressure measurement techniques.
Measured: Baseline and after 10 weeks
Forced Vital Capacity (FVC)
Pulmonary function assessed as forced vital capacity measured by spirometry according to standard guidelines.
Measured: Baseline and after 10 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function assessed as forced expiratory volume in one second measured by spirometry according to standard guidelines.
Measured: Baseline and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startJun 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies 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 allocated to one of three parallel groups: dynamic lumbar stabilization exercises, inspiratory muscle training, and a control group receiving usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Çolak, Medipol University
- Investigators
- Serpil Çolak, PT, PhD, Principal investigator, Bandırma Onyedi Eylül UniversityCandan Z Algun, PT, PhD, Study director, Medipol UniversityGürkan Yurteri, MD, Study chair, Rentek Diyaliz Merkezi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442240
- Sponsor's protocol ID
- HD-REHAB-2012
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study was conducted as part of an academic thesis and no data sharing plan was included in the original ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Dynamic Lumbar Stabilization Exercises and Inspiratory Muscle Training on Functional Independence in Patients Undergoing Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07442240
- Acronym / sponsor ID
- HD-REHAB-2012
- Keywords
- intradialytic exercise, rehabilitation, inspiratory muscle training, core stabilization, functional independence, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Mar 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 evaluated whether a rehabilitation program performed during hemodialysis sessions could improve daily functioning and mobility in adults receiving maintenance hemodialysis. Participants took part in either exercise-based rehabilitation, breathing muscle training, or usual care. The study compared changes in functional independence and mobility before and after the rehabilitation period.
Detailed description
This academic clinical study was conducted in two dialysis centers in Istanbul between June 2016 and March 2017. Adults undergoing maintenance hemodialysis were allocated to one of three groups: dynamic lumbar stabilization exercises, inspiratory muscle training, or a control group receiving routine nephrological care.
Participants in the intervention groups completed a supervised intradialytic rehabilitation program three times per week for 10 weeks. Functional independence and mobility-related performance were assessed at baseline and after completion of the intervention using validated functional assessment measures. The study was conducted as part of a doctoral thesis and is being retrospectively registered for transparency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were allocated to one of three parallel groups: dynamic lumbar stabilization exercises, inspiratory muscle training, and a control group receiving usual care.
| Arm | Type | Receives |
|---|---|---|
| Dynamic Lumbar Stabilization Exercise (DLSE) | Experimental | Behavioral: Dynamic Lumbar Stabilization ExercisesParticipants received a supervised intradialytic dynamic lumbar stabilization exercise program three times per week for 10 weeks in addition to usual care. |
| Respiratory Muscle Training (RMT) | Experimental | Behavioral: Respiratory Muscle TrainingParticipants received supervised respiratory muscle training during hemodialysis sessions three times per week for 10 weeks in addition to usual care. |
| Control Group | No intervention | –Participants received routine nephrological care during hemodialysis without additional exercise or rehabilitation interventions. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 25 to 45 years.
- Diagnosis of chronic kidney disease undergoing maintenance hemodialysis.
- Receiving hemodialysis for at least 6 months.
- Hemodialysis schedule of three sessions per week, four hours per session.
- Clinically stable at the time of enrollment.
Key exclusion criteria (5 listed)
- Acute medical conditions or unstable cardiovascular disease.
- Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise participation.
- Severe cognitive impairment or inability to follow instructions.
- Uncontrolled hypertension or other conditions contraindicating exercise.
- Participation in another structured exercise or rehabilitation program during the study period.
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 |
|---|---|---|
| Dynamic Lumbar Stabilization ExercisesA structured intradialytic exercise program focusing on trunk stabilization and neuromuscular control, performed under supervision during hemodialysis sessions. | Behavioural | Dynamic Lumbar Stabilization Exercise (DLSE) |
| Respiratory Muscle TrainingRespiratory muscle training performed during hemodialysis using threshold-based breathing exercises under supervision. | Behavioural | Respiratory Muscle Training (RMT) |
Primary outcome
Six-Minute Walk Test
Time frame: Baseline and after 10 weeks
Functional exercise capacity assessed as the distance walked in six minutes, measured according to standardized procedures.
6 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: Baseline and after 10 weeks
Five Times Sit-to-Stand Test (5STS)
Time frame: Baseline and after 10 weeks
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline and after 10 weeks
Maximal Expiratory Pressure (MEP)
Time frame: Baseline and after 10 weeks
Forced Vital Capacity (FVC)
Time frame: Baseline and after 10 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and after 10 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 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study was conducted as part of an academic thesis and no data sharing plan was included in the original ethics approval.
Related trials for Chronic Kidney Disease (Stages 4 and 5)
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
Not yet recruiting
Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers
Chronic Kidney Disease (Stages 4 and 5)
Not yet recruiting
Inspiratory Muscle Training During Hemodialysis
Chronic Kidney Disease (Stages 4 and 5), 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.
Serpil Çolak, PT, PhD principal investigator
Bandırma Onyedi Eylül University
Candan Z Algun, PT, PhD study director
Medipol University
Gürkan Yurteri, MD study chair
Rentek Diyaliz Merkezi
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Lumbar Stabilization Exercises and Respiratory Muscle Training in people with Chronic Kidney Disease (Stages 4 and 5) and Hemodialysis, run by Bandırma Onyedi Eylül 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 7 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 2 Mar 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?
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?
Six-Minute Walk Test (time frame: Baseline and after 10 weeks). 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 2 Mar 2026.