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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04696614
Other study ID # 108466
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2020
Est. completion date July 31, 2021

Study information

Verified date April 2022
Source National Taiwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents. Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan. The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents. In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week. Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage. Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks. Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT. The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date July 31, 2021
Est. primary completion date January 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 64 Years
Eligibility Inclusion Criteria: - Community residents (a) who are 40-65 years old without diet control, (b) body fat ? 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included. Exclusion Criteria: - This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise
intervention groups provided different sequential modality of exercise

Locations

Country Name City State
Taiwan Community Center Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary visceral adipose tissue measured using body composition analyzer three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
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