NCT05882994

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Status
unknown

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

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 8, 2023

Last Update Submit

May 27, 2023

Conditions

Keywords

Renal FailureExercisesFatigueSleep quality

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

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 .

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.

Interventions

rom exerciseBEHAVIORAL

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.

rom exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Renal InsufficiencyMotor ActivityFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Selda Arslan

    Selda Arslan, Phd Study Director Necmettin Erbakan University Faculty of Nursing

    STUDY DIRECTOR
  • ilknur örs

    Study Principal İnvestigator

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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