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The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05425498
Enrollment
28
Registered
2022-06-21
Start date
2022-06-30
Completion date
2024-06-01
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

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.

Interventions

OTHERPhysical activity program

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.

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood GlucoseChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksmg/dL
Waist circumferenceChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weekscentimeter
C-reactive proteinChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksmg/L
Glomerular filtration rateChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksml/dk/1.73m2
HeartScore systemChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksAssess cardiovascular risk.
Blood pressureChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksmmHg
Heart rateChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksbeats per minute
HemoglobinChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksg/dL
Body Mass IndexChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksBody Mass Index is weight in kilograms divided by height in meters squared. Formula: weight (kg) / \[height (m)\]2
Lipid profileChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weekstotal cholesterol level, LDL and HDL cholesterol, triglyceride (mg/dL)

Secondary

MeasureTime frameDescription
Exercise Stages of Change QuestionnaireChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksDetermines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance.
G-Walk sensor systemChange from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksAssess gait parameters. Gait parameters include gait speed (meters per second) and cadence (steps per minute).
Physical activity monitor (SenseWear Armband)Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeksAssess 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026