Effect of Progressive Exercise on Renal Transplant Patients

Overview

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.

Full Title of Study: “The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: May 15, 2023

Detailed Description

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.

Interventions

  • Behavioral: Progressive relaxation exercise
    • Progressive relaxation exercises will take 25-30 minutes of patients daily.

Arms, Groups and Cohorts

  • Experimental: exercise
    • 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.
  • No Intervention: Control
    • Participants will receive routine care.

Clinical Trial Outcome Measures

Primary Measures

  • Systolic and diastolic blood pressure
    • Time Frame: Change fron baseline at 4th week
    • Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)
  • fatigue level
    • Time Frame: Change from baseline at 4th week
    • 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).
  • Heart rate
    • Time Frame: Change from baseline at 4th week
    • Maintaining or normalizing heart rate within normal range (60 to 100 bpm)
  • Respiratory rate
    • Time Frame: Change from baseline at 4th week
    • Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)
  • Body temperature
    • Time Frame: Change from baseline at 4th week
    • Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
  • Oxygen saturation
    • Time Frame: Change from baseline at 4th week
    • Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baskent University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Seyda Uzun Yagız, Registered nurse – Baskent University
  • Overall Contact(s)
    • Şeyda Uzun Yağız, RN, +905392791581, seydauzun97@gmail.com

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