The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Kidney Transplant Recipients Clinical Trial

Official title:

The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05425498
• Other study ID #: 6039-GOA
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, physical activity barriers and gait parameters in kidney transplant recipients.

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, physical activity barriers and gait parameters in KTRs.

30 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Other:
• Physical 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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HeartScore system	Assess cardiovascular risk.	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	Blood pressure	mmHg	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	Heart rate	beats per minute	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	Hemoglobin	g/dL	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	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
Primary	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
Primary	Waist circumference	centimeter	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	C-reactive protein	mg/L	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	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
Primary	Proteinuria	mg/dL	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Primary	Blood Glucose	mg/dL	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary	Physical activity monitor (SenseWear Armband)	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.	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary	International Physical Activity Questionnaire - Long form	Assess physical activity level. Category 1 Low: <600 MET-min/week. Category 2 Moderate: 600-3000 MET-min/week, Category 3 High: >3000 MET- min/week.	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary	Exercise Stages of Change Questionnaire	Determines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance.	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary	Exercise Benefits/Obstacles Scale	Assess Physical activity barriers. The total score ranges from 43 to 172. The higher the total scale score, the more the individual understands the benefits of exercise.	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Secondary	G-Walk sensor system	Assess gait parameters. Gait parameters include gait speed (meters per second), cadence (steps per minute), stride length (meters), stride time (seconds), stance time (percent of gait cycle), swing time (percent of gait cycle), double support (percent of gait cycle), single support (percent of gait cycle) and pelvic angles during walking (degrees)	Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks