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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05876507
Other study ID # KA22/239
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date June 15, 2023

Study information

Verified date May 2023
Source Baskent University
Contact Seyda Uzun Yagiz, RN
Phone +905392791581
Email seydauzun97@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date June 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Baskent University Hospital Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Heart rate Maintaining or normalizing heart rate within normal range (60 to 100 bpm) Change from baseline at 4th week
Primary Respiratory rate Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute) Change from baseline at 4th week
Primary Body temperature Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement) Change from baseline at 4th week
Primary Oxygen saturation Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry) Change from baseline at 4th week
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