- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442240
Intradialytic Rehabilitation and Functional Independence in Hemodialysis Patients
Effects of Intradialytic Dynamic Lumbar Stabilization Exercises and Inspiratory Muscle Training on Functional Independence in Patients Undergoing Maintenance Hemodialysis
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dynamic Lumbar Stabilization Exercise (DLSE)
Participants received a supervised intradialytic dynamic lumbar stabilization exercise program three times per week for 10 weeks in addition to usual care.
|
A structured intradialytic exercise program focusing on trunk stabilization and neuromuscular control, performed under supervision during hemodialysis sessions.
|
|
Experimental: Respiratory Muscle Training (RMT)
Participants received supervised respiratory muscle training during hemodialysis sessions three times per week for 10 weeks in addition to usual care.
|
Respiratory muscle training performed during hemodialysis using threshold-based breathing exercises under supervision.
|
|
No Intervention: Control Group
Participants received routine nephrological care during hemodialysis without additional exercise or rehabilitation interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test (TUG)
Time Frame: Baseline and after 10 weeks
|
Functional mobility assessed by the time required to stand up from a chair, walk three meters, turn, walk back, and sit down.
|
Baseline and after 10 weeks
|
|
Five Times Sit-to-Stand Test (5STS)
Time Frame: Baseline and after 10 weeks
|
Lower extremity functional performance assessed as the time required to complete five consecutive sit-to-stand movements.
|
Baseline and after 10 weeks
|
|
Maximal Inspiratory Pressure (MIP)
Time Frame: Baseline and after 10 weeks
|
Inspiratory muscle strength measured as maximal inspiratory pressure using standardized respiratory pressure measurement techniques.
|
Baseline and after 10 weeks
|
|
Maximal Expiratory Pressure (MEP)
Time Frame: Baseline and after 10 weeks
|
Expiratory muscle strength measured as maximal expiratory pressure using standardized respiratory pressure measurement techniques.
|
Baseline and after 10 weeks
|
|
Forced Vital Capacity (FVC)
Time Frame: Baseline and after 10 weeks
|
Pulmonary function assessed as forced vital capacity measured by spirometry according to standard guidelines.
|
Baseline and after 10 weeks
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and after 10 weeks
|
Pulmonary function assessed as forced expiratory volume in one second measured by spirometry according to standard guidelines.
|
Baseline and after 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serpil Çolak, PT, PhD, Bandırma Onyedi Eylül University
- Study Director: Candan Z Algun, PT, PhD, Medipol University
- Study Chair: Gürkan Yurteri, MD, Rentek Diyaliz Merkezi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Breathing Exercises
Other Study ID Numbers
- HD-REHAB-2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodialysis
-
National Taiwan University HospitalCompletedHemodialysis Complication | Hemodialysis-Induced SymptomTaiwan
-
University Hospital, GhentEnrolling by invitationPediatric | Efficiency | Hemodialysis Treatment | Hemodialysis PatientBelgium
-
Khon Kaen UniversityCompletedHemodialysis | Hemodialysis Treatment | Dialysis AdequacyThailand
-
Vantive Health LLCBaxter Healthcare Corporation; Gambro Renal Products, Inc.Completed
-
Osaka UniversityCompleted
-
Chinese PLA General HospitalWithdrawn
-
University of HyogoCompleted
-
DVX, LLCNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Renal...Completed
-
Dong-A UniversityCompletedHemodialysisKorea, Republic of
Clinical Trials on Dynamic Lumbar Stabilization Exercises
-
Dow University of Health SciencesCompleted
-
Al-Azhar UniversityNot yet recruiting
-
Stefan KostadinovićCompletedChronic Low Back PainSerbia
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloUnknownLumbar Spine Disc HerniationBrazil
-
Hend HamdyNot yet recruiting
-
Yeditepe UniversityNot yet recruitingHealthy Older Adults | Age-Related Balance ImpairmentTurkey (Türkiye)
-
Esra BECENINot yet recruiting
-
National Institute of Rehabilitation, MexicoCompletedChronic Low Back Pain | Degenerative SpondylolisthesisMexico
-
Riphah International UniversityNot yet recruitingDiabetes Mellitus Type 2Pakistan
-
Cairo UniversityNot yet recruiting