The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

NCT ID: NCT05425498

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-06-01

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.

Conditions

Kidney Transplant Recipients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Activity Program Group

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.

Group Type: EXPERIMENTAL

Physical activity program

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Nihan BOZKURT

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylül University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

6039-GOA

Identifier Type: -

Identifier Source: org_study_id