- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07390656
Intradialytic Resistance and Flexibility Exercise in Hemodialysis Patients
Effects of Intradialytic Resistance and Flexibility Exercises on Clinical Outcomes in Hemodialysis Patients: A Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Muğla
-
Muğla, Muğla, Turkey (Türkiye), 48000
- Muğla Sıtkı Koçman University Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Exercise
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.
|
A structured resistance exercise program performed during routine hemodialysis sessions under supervision.
|
|
Experimental: Flexibility Exercise
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.
|
A structured flexibility and stretching exercise program performed during routine hemodialysis sessions under supervision.
|
|
No Intervention: Usual Care (Control)
Participants received usual hemodialysis care without any structured exercise program during dialysis sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From baseline to 12 weeks
|
|
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
|
From baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Short Form-36 (SF-36) Health-Related Quality of Life score
Time Frame: From baseline to 12 weeks
|
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. |
From baseline to 12 weeks
|
|
Change in Beck Depression Inventory score
Time Frame: From baseline to 12 weeks
|
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.
|
From baseline to 12 weeks
|
|
Change in body mass index (BMI)
Time Frame: From baseline to 12 weeks
|
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.
|
From baseline to 12 weeks
|
|
Change in fat tissue index (FTI)
Time Frame: From baseline to 12 weeks
|
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).
|
From baseline to 12 weeks
|
|
Change in lean tissue index (LTI)
Time Frame: From baseline to 12 weeks
|
Change in lean tissue index (LTI) assessed by bioelectrical impedance analysis (BIA), calculated from lean tissue mass normalized to height squared (kg/m^2).
|
From baseline to 12 weeks
|
|
Change in physical function assessed by the 6-minute walk test (6MWT)
Time Frame: From baseline to 12 weeks
|
Change in physical function assessed using the 6-minute walk test (6MWT), measured as the total distance walked in meters.
|
From baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilek Gibyeli Genek, MD, Muğla Sıtkı Koçman University, Faculty of Medicine
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
Other Study ID Numbers
- HD-EX-2020
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.
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