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Completed

NCT Number: NCT05425498

The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Blood pressure

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

    mmHg

  3. 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

  4. Hemoglobin

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

    g/dL

  5. 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

  6. 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)

  7. Waist circumference

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

    centimeter

  8. 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

  9. 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

  10. 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

  1. Physical activity monitor (SenseWear Armband)

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

    Assess physical activity. Number of steps, total energy expenditure (calories), day and night average sleep time (minutes), day and night average lying time (minutes), average metabolic equivalent (MET), energy expenditure consumed during moderate-intensity (3 MET) physical activity (calories), physical activity time (minutes, 3 METs) results are obtained.

  2. Exercise Stages of Change Questionnaire

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

    Determines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance.

  3. G-Walk sensor system

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

    Assess gait parameters. Gait parameters include gait speed (meters per second) and cadence (steps per minute).

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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