Effect of Progressive Exercise on Renal Transplant Patients

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Progressive relaxation exercise

About this trial

This is an interventional supportive care trial for Renal Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Baskent University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise

Control

Arm Description

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.

Participants will receive routine care.

Outcomes

Primary Outcome Measures

Systolic and diastolic blood pressure

Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)

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).

Heart rate

Maintaining or normalizing heart rate within normal range (60 to 100 bpm)

Respiratory rate

Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)

Body temperature

Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)

Oxygen saturation

Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

Secondary Outcome Measures

Full Information

NCT ID

NCT05876507

First Posted

March 9, 2023

Last Updated

May 24, 2023

Sponsor

Baskent University

1. Study Identification

Unique Protocol Identification Number

NCT05876507

Brief Title

Effect of Progressive Exercise on Renal Transplant Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2023 (Actual)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

Double (Participant, Outcomes Assessor)

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

exercise

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants will receive routine care.

Intervention Type

Behavioral

Intervention Name(s)

Progressive relaxation exercise

Intervention Description

Progressive relaxation exercises will take 25-30 minutes of patients daily.

Primary Outcome Measure Information:

Title

Systolic and diastolic blood pressure

Description

Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)

Time Frame

Change fron baseline at 4th week

Title

fatigue level

Description

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).

Time Frame