The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis
1 other identifier
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedMay 31, 2023
May 1, 2023
4 months
May 8, 2023
May 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Piper Fatigue Scale
The behavioral sub-dimension consists of six items, the affective sub-dimension consists of five items, the sensory sub-dimension consists of five items, and the cognitive sub-dimension consists of six items. Sub-dimension scores and total fatigue score are calculated over a total of 22 items. In the calculation of the total fatigue score, all scores of 22 items are added and divided by the number of items. 0 points obtained as a result of the average score; you have no fatigue, 1-3 points are "light tiredness", 4-6 points are "moderate tiredness", 7-10.
6 weeks after the first assessment
Pittsburgh Sleep Quality Index (PUKI)
PUKI is an index that evaluates sleep quality in the last month and consists of 19 questions and 7 components. The total score has a value between 0-21, a high total score indicates poor sleep quality. A total PSQI score of ≤5 means "good sleep" and \>5 means "bad sleep".
6 weeks after the first assessment
Study Arms (2)
rom exercise
EXPERIMENTALIn this study, ROM exercises will be applied by the researcher 2 days a week for 12 weeks to the intervention group separated by simple randomization method.In this study, considering the existing literature, it was planned to apply the exercise to the patients twice a week, for 12 weeks, with 5 minutes of warm-up, 15 minutes of rom exercises , and 5 minutes of cooling down . 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 researcher will have the patients perform rom exercises and supervise them during the exercise .
control group
NO INTERVENTIONPatients in the control group will receive routine care during hemodialysis.At the beginning of the study, participants will be asked to fill out data collection tools consisting of Personal Information Form, Piper Fatigue Scale, Pittsburgh Sleep Quality Index. Data will be collected with data collection tools in the 6th and 12th weeks.
Interventions
At the beginning of the study, participants will be asked to fill out data collection tools consisting of Personal Information Form, Piper Fatigue Scale, Pittsburgh Sleep Quality Index. Data will be collected with data collection tools in the 6th and 12th weeks. Evaluation will be done. At the end of the study, rom exercises will be applied to the patients in the control group.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Selda Arslan
Selda Arslan, Phd Study Director Necmettin Erbakan University Faculty of Nursing
- PRINCIPAL INVESTIGATOR
ilknur örs
Study Principal İnvestigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- single
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 31, 2023
Study Start
June 15, 2023
Primary Completion
October 15, 2023
Study Completion
June 15, 2024
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share