The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

NCT05425498 | Completed

• 1 other identifier: 6039-GOA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (10)

• HeartScore system

  Assess cardiovascular risk.

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Blood pressure

  mmHg

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Heart rate

  beats per minute

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Hemoglobin

  g/dL

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Body Mass Index

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

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Lipid profile

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

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Waist circumference

  centimeter

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• C-reactive protein

  mg/L

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Glomerular filtration rate

  ml/dk/1.73m2

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

• Blood Glucose

  mg/dL

  Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks

Secondary Outcomes (3)

• 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 Arms (2)

Physical Activity Program Group

EXPERIMENTAL

In the physical activity group, 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.

Other: Physical activity program

Control group

NO INTERVENTION

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.

Interventions

Physical activity program OTHER

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.

Physical Activity Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 21, 2022
• Study Start: June 30, 2022
• Primary Completion: April 29, 2024
• Study Completion: June 1, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

TU (1)