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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05957861
Other study ID # National Tainan Junior College
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date March 31, 2024

Study information

Verified date July 2023
Source National Tainan Junior College of Nursing
Contact Yu-Hsuan Chang, phD
Phone 01188662110600
Email fiona5252@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
web-based aerobic exercise
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Tainan Junior College of Nursing

Outcome

Type Measure Description Time frame Safety issue
Primary The change of cholesterol the unit is mg/dl two times (from baseline to the end of 16-week)
Primary The change of fasting sugar from blood sample the unit is mg/dl two times (from baseline to the end of 16-week)
Primary The change of insulin from blood sample the unit is µIU/mL two times (from baseline to the end of 16-week)
Primary The change of weight weight in kilograms, will be measured using body composition analyzer two times (from baseline to the end of 16-week)
Primary The change of waist circumference the unit is centimeters two times (from baseline to the end of 16-week)
Primary The change of body fat percentage the unit is %, will be measured using body composition analyzer two times (from baseline to the end of 16-week)
Primary The change of visceral fat the unit is square centimeters, will be measured using body composition analyzer two times (from baseline to the end of 16-week)
Primary The change of hip circumference the unit is centimeters. two times (from baseline to the end of 16-week)
Primary The change of High-density lipoprotein [HDL] the unit is mg/dl two times (from baseline to the end of 16-week)
Primary The change of low-density lipoprotein [LDH] the unit is mg/dl two times (from baseline to the end of 16-week)
Primary The change of triglycerides [TG] the unit is mg/dl two times (from baseline to the end of 16-week)
Secondary Adherence measurement Number of sessions attended/ Number of total sessions prescribed Each exercise session
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