The Effect of Joint Range of Motion and Benson Relaxation Exercises on Dialysis Adequacy, Treatment Adherence, and Quality of Life in Hemodialysis Patients

NCT07410416 | Not Yet Recruiting DMC

• 1 other identifier: AU-PMYO-VK-01
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemodialysis Patients

Keywords

Hemodialysis; range of motion; Benson relaxation exercises; quality of life; dialysis adequacy; treatment adherence

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

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.

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.

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.

Interventions

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.

Benson Relaxation Exercise Intervention (BREI)

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.

Range of Motion Intervention (ROMI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardahan University: lead

Related Links

• Pupmed

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Zümrüt Akgün Şahin, Associate Professor Dr.

  Kafkas University

  STUDY DIRECTOR

Central Study Contacts

Volkan Kına, Lecturer

CONTACT

+90 5452728948; vlknkna07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To determine randomization in sample selection, numbers from 1 to 72 were distributed into 3 groups using a simple random randomization method without repetition via https://www.random.org/. 72 patients were divided into three groups: Range of Motion Intervention, Benson Relaxation Exercise Intervention, and Control Group. Cards containing assignment information for intervention and control conditions were placed in pre-prepared, light-proof envelopes, and each envelope was numbered consecutively from 1 to 72. Each participant meeting the inclusion criteria was asked to randomly select one of these envelopes. The number inside the envelope chosen by the participant would be assigned to the relevant research group according to the pre-determined assignment list.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share