- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05957861
Exploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body Fat
Exploring the Effectiveness and Trajectory of Adherence to Web-based Exercise Among Community-dwelling Adults With High Body Fat
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Web-based exercise is effective alternative training for community residents on health improvement; however, adherence to their performance is challenging.
Purpose: This study aimed to (1) compare the effectiveness of 16-week exercise on improving blood samples, body composition, and anthropometric parameters between web-based exercise and supervised exercise; and (2) examine the trajectory of exercise adherence of web-based exercise for attendance and intensity over time for community-dwelling adults with high body fat.
Design: A two-arm randomized control trial. Method: Participants who received 16-week supervised exercise for aerobic exercise training on 2020 in our previous project was served as one of control groups (n = 34). In present project, purposive sampling will be used to enroll a target of 66 community-dwelling residents aged 40-64 years with inactive habits and body fat percentage ≧ of 25% for males and ≧ 30% for females in study. Eligible participants will be stratified by sex and then block randomly divided into web-based exercise or a control group (without any exercise intervention). The web-based exercise will prescribe a 30-minute of aerobic exercise at least moderate intensity prescription for three times per week. Heart rate reserve and self-perceived exertion will be self-recorded on the web by participants. Generalized estimating equations will be used to explore the effectiveness of web-based exercise.
Implications: The study findings can derive an effective exercise type either web-based or supervise exercise as well as build a series of exercise video that can promote self-exercise at home for health promotion for community residents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged from 40 to 64 years.
- have a body fat percentage of ≧25% if a man or ≧30% if a woman.
- can use the internet for watching the exercise video online.
- with inactive habit (≤ 3 days of physical activity per week and ≤ 30 min per session).
Exclusion Criteria:
- blind.
- currently under diet control.
- with any unsafety concern for their condition, such as pregnancy, myocardial infarction, stroke, or body fat percentage of ≧40%.
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: web-based exercise
Participants will receive web-based aerobic exercise (AE) training three times per week for 16 weeks.
|
Our designed AE program involved core muscle training through movements including marching, step touches, lunges, v-steps, box steps, twists, knee-ups, scoops, and scissors.
|
|
No Intervention: control group
control group without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of cholesterol
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is mg/dl
|
two times (from baseline to the end of 16-week)
|
|
The change of fasting sugar from blood sample
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is mg/dl
|
two times (from baseline to the end of 16-week)
|
|
The change of insulin from blood sample
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is μIU/mL
|
two times (from baseline to the end of 16-week)
|
|
The change of weight
Time Frame: two times (from baseline to the end of 16-week)
|
weight in kilograms, will be measured using body composition analyzer
|
two times (from baseline to the end of 16-week)
|
|
The change of waist circumference
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is centimeters
|
two times (from baseline to the end of 16-week)
|
|
The change of body fat percentage
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is %, will be measured using body composition analyzer
|
two times (from baseline to the end of 16-week)
|
|
The change of visceral fat
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is square centimeters, will be measured using body composition analyzer
|
two times (from baseline to the end of 16-week)
|
|
The change of hip circumference
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is centimeters.
|
two times (from baseline to the end of 16-week)
|
|
The change of High-density lipoprotein [HDL]
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is mg/dl
|
two times (from baseline to the end of 16-week)
|
|
The change of low-density lipoprotein [LDH]
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is mg/dl
|
two times (from baseline to the end of 16-week)
|
|
The change of triglycerides [TG]
Time Frame: two times (from baseline to the end of 16-week)
|
the unit is mg/dl
|
two times (from baseline to the end of 16-week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence measurement
Time Frame: Each exercise session
|
Number of sessions attended/ Number of total sessions prescribed
|
Each exercise session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yu-Hsuan Chang, phD, National Tainan Junior College of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- National Tainan Junior College
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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