Effect of Progressive Exercise on Renal Transplant Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Renal Transplant; Vital Signs; Nursing; Progressive Relaxation Exercise
• Intervention / Treatment: Behavioral: Progressive relaxation exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Şeyda Uzun Yağız, RN; Phone Number: +905392791581; Email: seydauzun97@gmail.com
• Study Contact Backup: Name: Sevcan Avcı Işık, PhD, RN; Phone Number: +905433177016; Email: sevcanavci@baskent.edu.tr

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06490
      • Recruiting
      • Baskent University Hospital
      • Contact: Şeyda Uzun Yağız, RN; Phone Number: +905392791581; Email: seydauzun97@gmail.com
      • Contact: Sevcan Avcı Işık, PhD, RN; Phone Number: +905433177016; Email: sevcanavci@baskent.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will receive routine care.
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.	Behavioral: Progressive relaxation exercise; Progressive relaxation exercises will take 25-30 minutes of patients daily.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): May 15, 2023
• Study Completion (Estimated): June 15, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: KA22/239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available. The researchers will decide later.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No