- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410416
The Effect of Joint Range of Motion and Benson Relaxation Exercises on Dialysis Adequacy, Treatment Adherence, and Quality of Life in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this randomized controlled trial is to determine the effects of range of motion and Benson relaxation exercises on dialysis adequacy, treatment adherence, and quality of life in patients undergoing hemodialysis. The patients in the study will be divided into three groups. One group will perform range of motion exercises, another group will perform Benson relaxation exercises, and the third group will receive no intervention and will be assigned as the control group. The study will be conducted three times a week for eight weeks. A pre-test will be administered before the start of the study. Further tests will be conducted at the end of weeks 4 and 8. The final test results will be collected at the end of week 10.
Research hypotheses:
H1: Range of motion exercises performed on hemodialysis patients during dialysis affect their dialysis parameters.
H2: Range of motion exercises performed on hemodialysis patients during dialysis affect their dialysis adequacy.
H3: Range of motion exercises performed on hemodialysis patients during dialysis affect their quality of life.
H4: Benson relaxation exercises performed on hemodialysis patients during dialysis affect their dialysis parameters.
H5: Benson relaxation exercises performed on hemodialysis patients during dialysis affect their dialysis adequacy.
H6: Benson relaxation exercises performed on hemodialysis patients during dialysis affect their quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Volkan Kına, Lecturer
- Phone Number: +90 5452728948
- Email: vlknkna07@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older
- Receiving HD treatment for at least 1 year
- Receiving HD treatment 3 days a week for 4 hours
- Being able to speak Turkish
- Volunteering to participate in the study
Exclusion Criteria:
- Patients with chronic diseases affecting breathing (advanced COPD, cancer)
- Patients with hearing or speech problems
- Patients with a diagnosed psychiatric condition
- Patients with conditions that impede movement, such as burns, open wounds, edema, thrombophlebitis, limited mobility, fistulas, or previous surgical operations in the extremities
Exclusion Criteria from the Study:
- Patients whose HD center changed during the study
- Patients who did not wish to continue with the study
- Patients who received a diagnosis of neurological or psychiatric illness during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Range of Motion Intervention (ROMI)
The study will be followed for 8 weeks for each patient.
Since patients receive hemodialysis treatment 3 times a week, each patient will receive 24 sessions.
The most frequent time interval for acute complications during hemodialysis is generally the first 1-2 hours of dialysis.
Therefore, patients in the intervention group will start Range of Motion Exercises in the second hour of dialysis.
|
Procedure Steps:
|
|
Active Comparator: Benson Relaxation Exercise Intervention (BREI)
The study will be implemented and each patient will be monitored for 8 weeks.
Since patients receive hemodialysis treatment 3 times a week, each patient will receive 24 sessions.
The most frequent time interval for acute complications during hemodialysis is generally the first 1-2 hours of dialysis.
Therefore, Benson Relaxation Exercises will be started in the second hour of dialysis for patients included in the intervention group.
|
Procedure Steps:
|
|
No Intervention: Control Group (CG)
The control group will not receive any intervention.
Patients will continue their routine hemodialysis treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SEVEN-POINT SUBJECTIVE GLOBAL ASSESSMENT (SGD-7P)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
It can be used to determine dialysis adequacy.
The SGD-7P scale will be used to assess the nutritional status of patients.
The SGD-7P was developed by Detsky et al. in 1984.
The Turkish validity and reliability study was conducted by Eminsoy et al. in 2019.
The scale has five evaluation criteria for medical history and three evaluation criteria for physical characteristics.
For each evaluation criterion, an option is selected on a scale of 1-7 points.
As a result of the average of the obtained scores, it is classified as 6-7 points (well-nourished), 3-5 points (mild-moderate malnutrition), and 1-2 points (severe malnutrition).
|
From enrollment to the end of treatment at 8 weeks
|
|
END-STAGE RENAL FAILURE - COMPLIANCE SCALE
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The scale was developed by Kim and Evangelista (2010).
The Turkish adaptation, validity, and reliability of the scale were carried out by Ok and Kutlu (2017).
The SDBYUÖ consists of 4 subscales: hemodialysis participation, medication adherence, fluid adherence, and diet adherence.
Hemodialysis participation is the sum of the scores of items 1, 3, and 5; medication adherence is the score of item 6; fluid adherence is the score of item 8; and diet adherence is the score of item 9.
The total score of the scale ranges from 0 to 1200.
A higher score indicates higher treatment adherence.
|
From enrollment to the end of treatment at 8 weeks
|
|
Kidney Disease Patients Quality of Life Scale (KDQOL-36)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The Turkish validity and reliability study of the scale, developed by Hayy et al. in 1994, was conducted by Yıldırım et al. in 2007.
The scale consists of two scales: the SF-12 form, comprising a summary of the physical component and a summary of the mental component.
It comprises a total of 4 sections and 36 items covering the burden of kidney disease, symptoms of kidney disease, and effects of kidney disease.
There is no total score; each dimension is scored between 0 and 100.
A score closer to 100 indicates a high quality of life, while a score closer to 0 indicates a low quality of life.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zümrüt Akgün Şahin, Associate Professor Dr., Kafkas Üniversity
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AU-PMYO-VK-01
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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