The Effect of Lower Extremity ROM Exercises on Hypotension, Fatigue, and Hemodialysis Comfort in Individuals

NCT06344273 | Completed

• 1 other identifier: Burcu01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Range of motion (ROM) is a term used to describe the amount of motion in each joint in our body. Every joint in the body has a normal range of motion. Maintaining the normal opening of the joints is achieved through movement. ROM exercises reduce contractures and are very important in terms of helping to preserve muscle movements. ROM exercises are an inexpensive method that can be applied in any environment, either as a group or individually, covering all muscle-joint groups. Individuals with disabilities can perform ROM exercises individually or receive support from healthcare professionals. It provides support to venous return by increasing muscle strength in patients who are immobilized for a long time. Based on this information, the aim of our study is to investigate the effect of lower extremity ROM exercises during hemodialysis on hypotension, fatigue and hemodialysis comfort. The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session.

Conditions

Hemodialysis

Keywords

fatique; hypotansion; hemodialysis comfort

Outcome Measures

Primary Outcomes (3)

• follow-up form

  the form is based on literature and created by researcher to follow patient' blood pressure. The data will enroll manually by researher on the form.

  2 weeks

• Piper Fatigue Scale

  the scale consists of a total of 22 items and evaluates the patient's subjective perception of fatigue with four subscales. These are: the behavior/severity subscale assessing the impact and severity of fatigue on daily life activities (6 items; 2-7); the affective subscale covering the emotional significance attributed to fatigue (5 items; 8-12); the sensory subscale reflecting the physical, emotional, and sensory symptoms of fatigue (5 items; 13-17); and the cognitive/mental subscale reflecting the level of impact of fatigue on cognitive functions and mental state (6 items; 18-23). Scoring of the Scale: Subscale scores are obtained by summing the scores of all items in that subscale and dividing by the number of items. Responses for each item are evaluated on a scale of 0-10 points. The total fatigue score is obtained by summing the scores of the 22 items and dividing by the number of items. Higher scores obtained from the scale indicate a higher perceived level of fatigue.

  2 weeks

• comfort condition

  we considered patients who are in both group with Hemodialysis Comfort Scale. the questionnaire is included 9 questions.

  2 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Lower Extremity ROM exercise will be performed for 20 minutes each at the beginning of the hour until the end of each eye session, examination and session in the case visits. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale", which are part of data collection, will be applied again at the end of the 1st and 2nd week after the sessions begin. The individual's life segments will be tracked and recorded at each session.

Behavioral: ROM exercises

Control Group

NO INTERVENTION

During the implementation period of the study, routine nursing care service will be provided to the patients in the control group and no additional nursing intervention will be applied. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale", which are part of data collection, will be applied again at the end of the 1st and 2nd week after the sessions begin. The individual's life segments will be tracked and recorded at each session.

Interventions

ROM exercises BEHAVIORAL

Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Agreeing to participate in the study and receiving written consent
• Without any cognitive, sensory and mental disorders
• Able to speak and communicate in Turkish
• Place, time and person orientation
• Those who do not have sensory and motor loss in their lower extremities (plegia, parasite, etc.)
• Individuals who do not have conditions such as mass, loss of sensation, fracture, wound, lesion in the lower extremities

You may not qualify if:

• Refused to participate in the study
• Patients with problems such as skin infections, thrombosis, phlebitis, fractures, circulatory disorders
• Patients who have undergone pharmacological or non-pharmacological interventions that will affect their vital signs
• Patients who want to withdraw from the research will not be included in the research process.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, 81000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: You are completely free to participate in the research or not. Not participating in this research will certainly not affect the service you receive. You have the right to withdraw from the study at any time by giving notice; you may also be excluded from the study by the investigator, if deemed necessary, provided that no harm is done to your medical condition. If you participate in the research, you will not be charged or paid any fees for the expenses to be made in the study. In addition, at the end of the research, your information will only serve scientific purposes without revealing your identity.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: April 3, 2024
• Study Start: July 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)