Clinical trial NCT05882994: The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis
Official title: The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure
Keywords: Renal Failure
Exercises
Fatigue
Sleep quality
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After obtaining the consent of 44 patients who met the inclusion criteria of the study, the selection of the patients to form the sample will be made at random according to the patient list in which the patient names in the institution are determined in alphabetical order and numbers. Two groups will be formed with at least one patient in each group, using a simple randomization method created on a computer (www.randomizer.org) by an independent researcher who was not involved in the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Range of motion exercises is a simple nursing action that has many benefits and is easy to perform independently . Hemodialysis patients are less active and have low intrinsic motivation for physical activity compared to sedentary healthy individuals. The aim of this study is to determine the effect of joint range of motion exercises on fatigue and sleep quality in patients receiving hemodialysis treatment. As a result of the literature review; The lack of a study on this subject and the inclusion of nurses, who play an important role in symptom management, in care interventions that are easy to learn and without complications, increase the quality of care.

Detailed description: In the advanced stage of chronic kidney disease, hemodialysis treatment is required to maintain the well-being of patients and improve their quality of life.It has been reported in the literature that the prevalence of fatigue varies between 60-97% in patients undergoing hemodialysis . Fatigue is a subjective feeling of weakness, loss of energy, tiredness and weakness. As a result of fatigue, patients experience limited participation in life and feel dependent. They often experience failure to be understood by others and meet expectations. This affects patients' self-esteem and causes problems with changing roles and relationships, identity, and meaning in life.

One of the most common complaints due to various reasons in patients receiving hemodialysis treatment is deterioration in sleep quality. In different studies conducted in patients receiving hemodialysis treatment, it has been reported that the deterioration in sleep quality varies between 53.3% and 87% . Deterioration in sleep quality, on the other hand, causes a decrease in patients' daily life activities, energy levels, self-care power and quality of life .

The quality of life has improved significantly, especially in the symptoms and effects of kidney disease. Range of another method of reducing the level of fatigue, is an activity or physical exercise to keep the body healthy, improve health, and maintain physical health. Range of motion is good for increasing cardiac output, alveolar ventilation, basal metabolic rate and joint mobilization. It is also a good option for reducing weakness and increasing stress tolerance.

Nurses have responsibilities in the symptom management of HD treatment, which reduces the quality of life of the patients, increases the stress level and negatively affects the physical and psychosocial aspects, supports the patients better, increases their quality of life, and provides evidence. Hemodialysis patients are inactive for an average of 12 hours per week during hemodialysis. By adding more functionality to the time spent on hemodialysis, it can improve patients' quality of life and increase compliance with treatment. The aim of this study is to determine the effect of range of motion exercises on the fatigue and sleep quality experienced by patients receiving hemodialysis treatment. As a result of the literature review, it was necessary to carry out this study in order not to carry out a study on this subject and to include nurses who play an important role in symptom management in their care interventions, which are easy to learn and do not have any complications, and to improve the quality of care with their applications. The aim of the study is to determine the effect of range of motion exercises applied to hemodialysis patients on fatigue and sleep quality.

METHOD: It was designed as a parallel group randomized controlled study. Reporting of the study will adhere to the CONSORT scheme for parallel group randomized trials.

Management:In the current hemodialysis unit, patients receive hemodialysis treatment in bed. In the study, ROM application will be applied on the same day of hemodialysis treatment. In the literature, it is recommended to apply exercise for 15 minutes in the first 2 hours of the hemodialysis session. Since patients experience fluid accumulation in the body before hemodialysis begins, such excess fluids should be removed within 4-5 hours. This rapid release of fluids from the body can sometimes lead to hemodynamic changes and symptoms such as hypotension or cramping. Because Based on the literature review recommendations of specialist physicians and nurses, the best time for intervention will be considered 30 minutes after the start of dialysis and during the first 2 hours of dialysis .

In this study, considering the existing literature, it was planned to apply range of motion exercises to patients twice a week, for 12 weeks and for 15 minutes. Range of motion exercises include wrist rotation (clockwise and counterclockwise), wrist flexion and extension. elbow joint full flexion and extension; rotating ankles (clockwise and counterclockwise); and full flexion and extension of the ankles will be performed. Each movement will be made 20 rounds per minute. The co-investigator will have the intervention group undergo ROM and supervise them during hemodialysis. The investigator will pay attention to the comfort of the patients and whether they experience problems such as shortness of breath, fatigue or nausea during the intervention .

Before ROM exercises, the patients in the intervention group will be checked for blood pressure and pulse.

Control group patients will be given routine treatment and care. After the research is completed, ROM exercises will be performed on the control group.

Application:

When the implementation phase of the research begins, the purpose of the research will be explained and written/verbal consent will be obtained.

Eligibility criteria: Inclusion Criteria:

* over 18 years,

  * literate,
  * Receiving hemodialysis treatment for at least 6 months,
  * Hemodialysis patients who volunteered to participate in the study will be included in the study.

Exclusion Criteria:

* Having an additional disease that triggers fatigue (advanced COPD, heart failure, asthma, cancer, etc.),

  * Hearing and communication problems,
  * Having a psychiatric diagnosis (major depression etc.),
  * History of myocardial infarction or unstable angina in the last 12 months
  * Severe uncontrolled diabetes
  * Uncontrolled hypertension with systolic blood pressure \>200 mmHg and/or diastolic blood pressure \>120 mmHg,
  * Those with tendon, ligament or muscle tear, Unhealed fracture,
  * Patients with deep vein thrombosis will not be included in the study.

Primary outcomes:
measure: Piper Fatigue Scale
timeFrame: 6 weeks after the first assessment
measure: Pittsburgh Sleep Quality Index (PUKI)
timeFrame: 6 weeks after the first assessment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Selda Arslan, Phd Study Director Necmettin Erbakan University Faculty of Nursing
name: Selda Arslan
role: STUDY_DIRECTOR
affiliation: Study Principal İnvestigator
name: ilknur örs
role: PRINCIPAL_INVESTIGATOR
References: