Hemodialysis PatientsNCT07410416
The Effect of Joint Range of Motion and Benson Relaxation Exercises on Dialysis Adequacy, Treatment Adherence, and Quality of Life in Hemodialysis Patients
A study testing Range of Motion Intervention (ROMI) and Benson Relaxation Exercise Intervention (BREI) in people with Hemodialysis Patients, run by Ardahan University.
Trial summary
The aim of this study is to determine the effects of range of motion and Benson relaxation exercises applied to patients undergoing hemodialysis treatment on dialysis adequacy, treatment adherence, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Range of Motion Intervention (ROMI) and Benson Relaxation Exercise Intervention (BREI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 16 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to determine the effects of range of motion and Benson relaxation exercises applied to patients undergoing hemodialysis treatment on dialysis adequacy, treatment adherence, and quality of life.
Read the 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.
- Conditions
- Hemodialysis Patients
- Being tested
- Range of Motion Intervention (ROMI), Benson Relaxation Exercise Intervention (BREI)
- Keywords
- Hemodialysis, range of motion, Benson relaxation exercises, quality of life, dialysis adequacy, treatment adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Range of Motion Intervention (ROMI)Other
Procedure Steps:
- The patient is evaluated for factors that may affect the procedure (restricted movement, presence of fistula, history of surgery, etc.). • The patient is placed in the supine position. • Movements are performed from head to toe. • Each movement is repeated 3-5 times. • With the patient's head and chin supported, the following movements are performed sequentially: flexion, extension, hyperextension, right lateral flexion, left lateral flexion, right rotation, and left rotation of the head.
- The patient's shoulder is supported. Without bending the elbow, the following movements are performed sequentially: flexion, extension, adduction, abduction, internal and external rotation. The same movements are performed sequentially for the forearm, wrist, and fingers.
- All movements are performed sequentially for the other arm, hip, and both legs.
Benson Relaxation Exercise Intervention (BREI)Other
Procedure Steps:
- The patient is asked to choose a word that is important to them and that they can focus their attention on (health, well-being, love, affection, God, etc.), a prayer, or a short sentence.
- They are asked to close their eyes in a calm environment and in a comfortable position.
- They are asked to slowly relax their muscles from foot to head (foot, calf, thigh, abdomen, chest, shoulder, neck, and head). • They are asked to breathe in through their nose and repeat the chosen word as they exhale.
- They are asked to continue the procedure for 10-20 minutes. They are informed that they can open their eyes occasionally to monitor the time, but they should not set an alarm. • After the procedure is complete, they are asked to wait a few minutes with their eyes closed. Then, they are asked to wait a few minutes with their eyes open. • The patient is informed that they should not worry about whether they performed the procedure correctly.
| Study group | Role | What they receive |
|---|---|---|
| Range of Motion Intervention (ROMI) | Active comparator | 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. Receives: Other: Range of Motion Intervention (ROMI) |
| Benson Relaxation Exercise Intervention (BREI) | Active comparator | 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. Receives: Other: Benson Relaxation Exercise Intervention (BREI) |
| Control Group (CG) | No intervention | The control group will not receive any intervention. Patients will continue their routine hemodialysis treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEVEN-POINT SUBJECTIVE GLOBAL ASSESSMENT (SGD-7P)
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).
Measured: From enrollment to the end of treatment at 8 weeks
END-STAGE RENAL FAILURE - COMPLIANCE SCALE
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.
Measured: From enrollment to the end of treatment at 8 weeks
Kidney Disease Patients Quality of Life Scale (KDQOL-36)
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves three different groups. Two of these groups are experimental, and one is a control group. One experimental group will perform range of motion exercises, and the other will perform Benson relaxation exercises. The control group will receive no intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Kina, Ardahan University
- Investigators
- Zümrüt Akgün Şahin, Associate Professor Dr., Study director, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410416
- Sponsor's protocol ID
- AU-PMYO-VK-01
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I plan to share the findings of this research in the form of a research paper.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Joint Range of Motion and Benson Relaxation Exercises on Dialysis Adequacy, Treatment Adherence, and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07410416
- Acronym / sponsor ID
- AU-PMYO-VK-01
- Conditions
- Hemodialysis Patients
- Keywords
- Hemodialysis, range of motion, Benson relaxation exercises, quality of life, dialysis adequacy, treatment adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 13 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.
The aim of this study is to determine the effects of range of motion and Benson relaxation exercises applied to patients undergoing hemodialysis treatment on dialysis adequacy, treatment adherence, and quality of life.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study involves three different groups. Two of these groups are experimental, and one is a control group. One experimental group will perform range of motion exercises, and the other will perform Benson relaxation exercises. The control group will receive no intervention.
| Arm | Type | Receives |
|---|---|---|
| Range of Motion Intervention (ROMI) | Active comparator | Other: 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. |
| Benson Relaxation Exercise Intervention (BREI) | Active comparator | Other: 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. |
| Control Group (CG) | No intervention | –The control group will not receive any intervention. Patients will continue their routine hemodialysis treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Patients whose HD center changed during the study
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 |
|---|---|---|
| Range of Motion Intervention (ROMI)Procedure Steps: * The patient is evaluated for factors that may affect the procedure (restricted movement, presence of fistula, history of surgery, etc.). • The patient is placed in the supine position. • Movements are performed from head to toe. • Each movement is repeated 3-5 times. • With the patient's head and chin supported, the following movements are performed sequentially: flexion, extension, hyperextension, right lateral flexion, left lateral flexion, right rotation, and left rotation of the head. * The patient's shoulder is supported. Without bending the elbow, the following movements are performed sequentially: flexion, extension, adduction, abduction, internal and external rotation. The same movements are performed sequentially for the forearm, wrist, and fingers. * All movements are performed sequentially for the other arm, hip, and both legs. | Other | Range of Motion Intervention (ROMI) |
| Benson Relaxation Exercise Intervention (BREI)Procedure Steps: * The patient is asked to choose a word that is important to them and that they can focus their attention on (health, well-being, love, affection, God, etc.), a prayer, or a short sentence. * They are asked to close their eyes in a calm environment and in a comfortable position. * They are asked to slowly relax their muscles from foot to head (foot, calf, thigh, abdomen, chest, shoulder, neck, and head). • They are asked to breathe in through their nose and repeat the chosen word as they exhale. * They are asked to continue the procedure for 10-20 minutes. They are informed that they can open their eyes occasionally to monitor the time, but they should not set an alarm. • After the procedure is complete, they are asked to wait a few minutes with their eyes closed. Then, they are asked to wait a few minutes with their eyes open. • The patient is informed that they should not worry about whether they performed the procedure correctly. | Other | Benson Relaxation Exercise Intervention (BREI) |
Primary outcome
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- PupmedLink provided by the sponsor.
- Individual participant dataSharing planned: No. I plan to share the findings of this research in the form of a research paper.
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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.
Zümrüt Akgün Şahin, Associate Professor Dr. study director
Kafkas University
Questions about this trial
What is this clinical trial studying?
A study testing Range of Motion Intervention (ROMI) and Benson Relaxation Exercise Intervention (BREI) in people with Hemodialysis Patients, run by Ardahan 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volkan Kına, Lecturer (+90 5452728948, vlknkna07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEVEN-POINT SUBJECTIVE GLOBAL ASSESSMENT (SGD-7P) (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. 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 13 Feb 2026.