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Clinical Trials/NCT05425498
NCT05425498
Completed
N/A

The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Dokuz Eylul University1 site in 1 country28 target enrollmentJune 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Kidney Transplant Recipients
Sponsor
Dokuz Eylul University
Enrollment
28
Locations
1
Primary Endpoint
HeartScore system
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in kidney transplant recipients.

Detailed Description

The Transtheoretical Model evaluates readiness for behavior change. The Transtheoretical Model has been frequently used to determine how individuals adopt and maintain physical activity. In kidney transplant recipients (KTRs), increased physical activity level is associated with better graft function, and decreased physical activity is associated with increased cardiovascular and all-cause mortality. Therefore, it is important to evaluate the level of physical activity and to gain physical activity habits in KTRs. The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in KTRs. 28 KTRs who meet the inclusion criteria will be assigned to the physical activity program or control group by non-randomization method. In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks. In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.

Registry
clinicaltrials.gov
Start Date
June 30, 2022
End Date
June 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hatice Nihan BOZKURT

Research Assistant

Dokuz Eylul University

Eligibility Criteria

Inclusion Criteria

  • to be at least 18 years old
  • to have had a kidney transplantation at least 6 months ago

Exclusion Criteria

  • Pregnancy
  • Multiple organ transplantation
  • Severe cognitive impairment (Mini Mental Test score less than 24)
  • Uncorrected visual impairment
  • Certain neurological pathology (parkinson, stroke, epilepsy)
  • Orthopedic surgery or injury to the lower extremity that will affect individuals' participation in daily life
  • Inability to walk independently

Outcomes

Primary Outcomes

HeartScore system

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

Assess cardiovascular risk.

Blood pressure

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

mmHg

Heart rate

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

beats per minute

Hemoglobin

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

g/dL

Body Mass Index

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

Body Mass Index is weight in kilograms divided by height in meters squared. Formula: weight (kg) / \[height (m)\]2

Lipid profile

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

total cholesterol level, LDL and HDL cholesterol, triglyceride (mg/dL)

Waist circumference

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

centimeter

C-reactive protein

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

mg/L

Glomerular filtration rate

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

ml/dk/1.73m2

Blood Glucose

Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

mg/dL

Secondary Outcomes

  • Physical activity monitor (SenseWear Armband)(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)
  • Exercise Stages of Change Questionnaire(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)
  • G-Walk sensor system(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)

Study Sites (1)

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