The Effect of Joint Range of Motion and… | Clinical Trial

Key information

Conditions

Hemodialysis Patients Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Volkan Kına, Lecturer

CONTACT

[email protected]

+90 5452728948

Sponsors and collaborators

Lead sponsor

Ardahan University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 13, 2026
Registry last updated: Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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