- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07493642
Multimedia Health Education on Physical Fitness and Physical Activity for Patients With Chronic Kidney Disease
This clinical trial aims to determine whether a multimedia educational intervention can effectively improve physical fitness and physical activity levels in patients with chronic kidney disease (CKD), while also evaluating its overall outcomes.
The study primarily seeks to answer the following questions:
- Can multimedia education enhance CKD patients' cardiorespiratory endurance, muscle strength, flexibility, and physical activity levels?
- Do patients receiving multimedia education demonstrate greater improvements in health behavior and fitness compared to those receiving standard education alone?
Researchers will compare a multimedia educational video program with conventional patient education to assess whether the multimedia approach helps patients maintain regular exercise and improve physical performance.
Participants will:
- Be randomly assigned to either the multimedia education group or the standard education group.
- Take part in a 12-week intervention and assessment period.
- Undergo pre- and post-intervention evaluations, including:
- Six-minute walk test, grip strength and chair-stand test, flexibility test, and body composition analysis (BMI, waist-to-hip ratio, InBody).
- Completion of a physical activity questionnaire (IPAQ-C). The findings will be used to evaluate the clinical value of multimedia education in CKD management and to support the development of effective patient exercise education programs.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HUEI SHIN WEN
- Phone Number: +886963012591
- Email: cvicky851122@gmail.com
Study Locations
-
-
Taishan District
-
New Taipei City, Taishan District, Taiwan, 243
- Recruiting
- Fu Jen Catholic University Hospital
-
Contact:
- HUEI SHIN WEN
- Phone Number: +886963012591
- Email: cvicky851122@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Conscious adults aged 20 years or older who are literate and able to communicate in Mandarin or Taiwanese.
- Diagnosed with chronic kidney disease (CKD) stage 1 to 3b according to the CKD-EPI formula and confirmed by a nephrologist.
- Able to operate a mobile device (such as a smartphone, tablet, or computer) and have access to equipment capable of playing multimedia videos; family members or caregivers may assist if necessary.
- Able to view and understand multimedia educational video content.
Exclusion Criteria:
- Individuals with cognitive or psychiatric disorders that prevent understanding or adherence to the exercise program.
- Individuals with gait instability or limb amputation who are unable to perform the exercise protocol.
- Individuals with poorly controlled cardiovascular disease, such as heart failure, myocardial infarction, angina, arrhythmia, or those who have experienced chest pain during activity or rest within the past three months.
- Individuals deemed unsuitable for exercise by their attending physician.
- Individuals with poorly controlled diabetes (HbA1C > 9%) accompanied by retinopathy or foot ulcers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multimedia Health Education
|
Participants in this group will receive a multimedia exercise education program designed for patients with chronic kidney disease (CKD).
The program includes instructional videos demonstrating proper exercise techniques, safety guidelines, and motivational content to encourage regular physical activity.
The intervention aims to enhance participants' exercise knowledge, physical fitness, and activity levels over a 12-week period.
|
|
Active Comparator: Standard Education Group
Standard CKD Education
|
Standard CKD Education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in 6-minute walk test distance from baseline to 12 weeks, measured in meters.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level (IPAQ-C)
Time Frame: Baseline and 12 weeks after intervention
|
Change in physical activity level measured by the International Physical Activity Questionnaire - Chinese version (IPAQ-C) from baseline to 12 weeks.
Total physical activity will be expressed in metabolic equivalent task minutes per week (MET-min/week), with higher scores indicating higher levels of physical activity.
|
Baseline and 12 weeks after intervention
|
|
Change in handgrip strength from baseline to 12 weeks, measured in kilograms.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
|
|
Change in chair stand test performance from baseline to 12 weeks, measured by number of repetitions completed in 30 seconds.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
|
|
Change in sit-and-reach test score from baseline to 12 weeks, measured in centimeters.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
|
|
Change in waist-to-hip ratio from baseline to 12 weeks.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
|
|
Change in body mass index from baseline to 12 weeks, measured in kg/m².
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
|
|
Change in body composition from baseline to 12 weeks, including body fat percentage and skeletal muscle mass.
Time Frame: Baseline and 12 weeks after intervention
|
Baseline and 12 weeks after intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- FJUH114494
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Disease (CKD)
-
Adia Med of Winter Park LLCRecruitingChronic Kidney Disease | CKD | Kidney Disease, Chronic | Kidney Disease | Chronic Kidney Disease (CKD)United States
-
Fan Fan HouUnknown
-
Menoufia UniversityTanta UniversityNot yet recruitingCKD - Chronic Kidney Disease
-
Seoul National University HospitalSamsung Medical Center; Pusan National University Hospital; Asan Medical Center; Yonsei University and other collaboratorsUnknownChronic Kidney Disease(CKD)Korea, Republic of
-
PT. Daewoong InfionEquilab InternationalCompletedChronic Kidney Disease (CKD)Indonesia
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
PfizerHospira, now a wholly owned subsidiary of PfizerCompletedChronic Kidney Disease (CKD)United States, Puerto Rico
-
University of British ColumbiaPfizer; The Kidney Foundation of CanadaCompleted
-
International Centre for Diarrhoeal Disease Research...Child Health Research Foundation, Bangladesh; Hiroshima UniversityUnknownCommunity-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health EducationChronic Kidney Disease (CKD)Bangladesh
-
University of MagdeburgMedical Laboratory Schenk-Ansorge Magdeburg Germany.CompletedChronic Kidney Disease (CKD)Germany
Clinical Trials on Multimedia Health Education
-
Changzhou No.2 People's HospitalRecruitingAnxiety | Vitreous FloatersChina
-
Chang Gung Memorial HospitalNational Taipei University of Nursing and Health SciencesRecruitingAnxiety | CataractTaiwan
-
Hepatopancreatobiliary Surgery Institute of Gansu...CompletedHealth EducationChina
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedType 2 Diabetes Mellitus | Insulin | Education
-
National Taiwan University HospitalNot yet recruiting
-
Chang Gung Memorial HospitalCompletedQuality of Life | Enterostomy | Self-care | Multimedia Learning EducationTaiwan
-
Akdeniz UniversityCompleted
-
National Cheng-Kung University HospitalEnrolling by invitationChemotherapy | ICU | Nurse | Self-Efficacy | eLearningTaiwan
-
Royal College of Surgeons, IrelandEIDO HealthcareCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedAnxiety | Abnormal Uterine BleedingTurkey