Effect of Progressive Exercise on Renal Transplant Patients

Sponsor

Baskent University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05876507

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Fatigue Vital Signs Progressive Relaxation Exercise Nursing	Behavioral: Progressive relaxation exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 13, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control Participants will receive routine care.

Arm

Intervention/Treatment

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.

No Intervention: Control

Participants will receive routine care.

Outcome Measures

Primary Outcome Measures

Systolic and diastolic blood pressure [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 [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 [Change from baseline at 4th week]
Maintaining or normalizing heart rate within normal range (60 to 100 bpm)
Respiratory rate [Change from baseline at 4th week]
Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)
Body temperature [Change from baseline at 4th week]
Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
Oxygen saturation [Change from baseline at 4th week]
Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University Hospital	Ankara	Çankaya	Turkey	06490

Sponsors and Collaborators

Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seyda Uzun Yagız, Registered nurse, Baskent University

ClinicalTrials.gov Identifier:

NCT05876507

Other Study ID Numbers:

KA22/239

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of May 25, 2023