NCT05876507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

March 9, 2023

Last Update Submit

May 24, 2023

Conditions

Renal TransplantFatigueVital SignsProgressive Relaxation ExerciseNursing

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will receive routine care.

Interventions

Progressive relaxation exerciseBEHAVIORAL

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

exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Hospital

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Şeyda Uzun Yağız, RN

CONTACT

+905392791581seydauzun97@gmail.com

Sevcan Avcı Işık, PhD, RN

CONTACT

+905433177016sevcanavci@baskent.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered nurse

Study Record Dates

First Submitted

March 9, 2023

First Posted

May 25, 2023

Study Start

February 13, 2023

Primary Completion

May 15, 2023

Study Completion

June 15, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

It is not yet known if there will be a plan to make IPD available. The researchers will decide later.

Locations

TU(1)