Clinical trial NCT05425498: The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
Official title: The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Recipients
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HeartScore system
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Blood pressure
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Heart rate
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Hemoglobin
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Body Mass Index
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Lipid profile
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Waist circumference
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: C-reactive protein
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Glomerular filtration rate
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Blood Glucose
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary outcomes:
measure: Physical activity monitor (SenseWear Armband)
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: Exercise Stages of Change Questionnaire
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
measure: G-Walk sensor system
timeFrame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
References: