Kidney Transplant RecipientsNCT05425498
The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
A study testing Physical activity program in people with Kidney Transplant Recipients, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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, and gait parameters in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be at least 18 years old
- to have had a kidney transplantation at least 6 months ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Physical activity program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HeartScore system
Assess cardiovascular risk.
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Blood pressure
mmHg
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Heart rate
beats per minute
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Hemoglobin
g/dL
Measured: 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
Measured: 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)
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Waist circumference
centimeter
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
C-reactive protein
mg/L
Measured: 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
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Blood Glucose
mg/dL
Measured: 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)
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.
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
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.
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
G-Walk sensor system
Assess gait parameters. Gait parameters include gait speed (meters per second) and cadence (steps per minute).
Measured: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start30 Jun 2022
- Primary completion29 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Nihan BOZKURT, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425498
- Sponsor's protocol ID
- 6039-GOA
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05425498
- Acronym / sponsor ID
- 6039-GOA
- Conditions
- Kidney Transplant Recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Program Group | Experimental | Other: Physical activity programIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to be at least 18 years old
- to have had a kidney transplantation at least 6 months ago
Key exclusion criteria (7 listed)
- Pregnancy
- Multiple organ transplantation
- Severe cognitive impairment (Mini Mental Test score less than 24)
- Uncorrected visual impairment
- Certain neurological pathology (parkinson, stroke, epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity program12-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. | Other | Physical Activity Program Group |
Primary outcome
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.
Blood pressure
Time frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mmHg
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
Hemoglobin
Time frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
g/dL
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
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)
Waist circumference
Time frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
centimeter
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
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Kidney Transplant Recipients, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HeartScore system (time frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.