Renal FailureNCT05882994
The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis
A study testing rom exercise in people with Renal Failure, run by Necmettin Erbakan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- rom exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis Patients: Randomized Controlled Study
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.
Read the 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.
- Conditions
- Renal Failure
- Being tested
- rom exercise
- Keywords
- Renal Failure, Exercises, Fatigue, Sleep quality
- Medical subject headings
- Renal Insufficiency, Motor Activity, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rom exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rom exercise | Experimental | In 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 . Receives: Behavioral: rom exercise |
| control group | No intervention | Patients 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 6 weeks after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İLKNUR ÖRS, Necmettin Erbakan University
- Investigators
- Selda Arslan, Study director, Selda Arslan, Phd Study Director Necmettin Erbakan University Faculty of Nursingilknur örs, Principal investigator, Study Principal İnvestigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882994
- Sponsor's protocol ID
- Necmettin Erbakan Üniversty
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Range of Motion Exercises on Fatigue and Sleep Quality in Hemodialysis Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05882994
- Acronym / sponsor ID
- Necmettin Erbakan Üniversty
- Conditions
- Renal Failure
- Keywords
- Renal Failure, Exercises, Fatigue, Sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 31 May 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| rom exercise | Experimental | Behavioral: rom exerciseIn 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 intervention | –Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years,
Key exclusion criteria (8 listed)
- Having an additional disease that triggers fatigue (advanced COPD, heart failure, asthma, cancer, etc.),
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 |
|---|---|---|
| rom exerciseAt 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. | Behavioural | rom exercise |
Primary outcome
Piper Fatigue Scale
Time frame: 6 weeks after the first assessment
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.
Pittsburgh Sleep Quality Index (PUKI)
Time frame: 6 weeks after the first assessment
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- The Effect of Intradialytic Range of Motion Exercise on Dialysis Adequacy and Fatigue in Hemodialysis PatientsLink provided by the sponsor.
- The effect of intradialytic aerobic exercise on dialysis efficacy in hemodialysis patients: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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. This study is not recruiting at the moment.
Selda Arslan study director
Selda Arslan, Phd Study Director Necmettin Erbakan University Faculty of Nursing
ilknur örs principal investigator
Study Principal İnvestigator
Questions about this trial
What is this clinical trial studying?
A study testing rom exercise in people with Renal Failure, run by Necmettin Erbakan 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilknur Örs (05072815282, ilknurozkanors@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piper Fatigue Scale (time frame: 6 weeks after the first assessment). The study lists 2 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 31 May 2023.