Effect of Progressive Exercise on Renal Transplant Patients

Study Overview
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Brief Summary
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The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.

Detailed Description
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Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation. In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.

Official Title
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The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant

Conditions
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Renal Transplant, Fatigue, Vital Signs, Progressive Relaxation Exercise, Nursing

Intervention / Treatment
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* Behavioral: Progressive relaxation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients underwent renal transplant within one year from the beginning of the study Patients having no communication problems Patients having a smart phone either own or o family member Exclusion Criteria: Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single blind, randomized controlled study. The intervention group will receive an audio record explaining progressive relaxation exercise. Then participants will undergo training about the exercises. After training, the intervention group will perform the exercises at home by their own. The exercises will be performed everyday for 4 weeks about 25-30 minutes. Principal investigator will check the participants weekly about implementation of exercises.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>Participants will receive a training about progressive relaxation exercises on the first day, then given an audio-record containing instructions about exercises. They will perform exercises at home for 4 week and revisited by the principal investigator at the 2nd and 4th week. | Behavioral: Progressive relaxation exercise<br>* Progressive relaxation exercises will take 25-30 minutes of patients daily.<br>|
| No Intervention: Control<br>Participants will receive routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure | Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg) | Change fron baseline at 4th week | 
| fatigue level | Fatigue Severity Scale is a valid and 7-point Likert type scale. Possible scores range from 9-63. Higher scores indicate high level of fatigue. A score of 36 points or over indicates severe fatigue (Change= Lower score from the scale at the end of intervention compared to baseline). | Change from baseline at 4th week | 
| Heart rate | Maintaining or normalizing heart rate within normal range (60 to 100 bpm) | Change from baseline at 4th week | 
| Respiratory rate | Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute) | Change from baseline at 4th week | 
| Body temperature | Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement) | Change from baseline at 4th week | 
| Oxygen saturation | Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry) | Change from baseline at 4th week |