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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215275
Other study ID # 109-516
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2022
Est. completion date November 30, 2023

Study information

Verified date March 2024
Source National Tainan Junior College of Nursing
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of this project are to compare the effects between 8-week moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) on improving HRV.


Description:

Background: Both heart rate variability (HRV) and visceral adipose tissue (VAT) are crucial factors predicting cardiovascular diseases, and both can be improved by exercise training. HRV can provide information regarding sympathetic and parasympathetic activity. Studies have demonstrated that HRV and VAT are correlated. VAT accumulation may dysregulate the balance of the sympathetic and parasympathetic nervous system. However, the correlation between sympathetic activation and VAT is controversial and limited by a paucity of studies, and the optimal exercise modality for improving HRV remains debatable. Therefore, the aims of this 1-year project are to compare the effects between 8-week moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) on improving HRV. Methods: Purposive sampling will be used to enroll at least 72 community residents aged 40-64 years with VAT over 100 cm2. A two-phase crossover design will be used to understand the change patterns of HRV and VAT in the 8-week different exercise phase and with 8-week washout period insertion. Participants will initially be randomized into either the MICT or HIIT group for 8 weeks, and the groups will then be exchanged for the later 8 weeks. HRV parameters and VAT will be measured at four time points at baseline (T0), the end of the first phase (8-week later, T1), the initial of second phase (16-week later, T2), and the end of the second phase (24-week later, T2). Linear mixed models (LMMs) with random effects will be used to compare the effects of 8-week different exercise modalities on HRV and explore the effect of VAT changes on HRV over the 24-week intervention. Relevance to clinical practice: The results of this study can reveal the optimal exercise modality for improving HRV among community residents with higher VAT and clarify HRV and VAT change patterns in exercise and rest phase and the correlation between HRV and VAT. These findings would provide evidence that clinical health professionals can use to promote health benefits through exercise intervention.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 64 Years
Eligibility Inclusion Criteria: - Community residents (a) who are 40-64 years old, (b) with a VAT of ? 100 cm2 measured using a body composition analyzer, and (c) who can communicate in Mandarin or Taiwanese will be included. Exclusion Criteria: - This study will exclude (a) residents with recent unstable conditions (stroke, cardiovascular and respiratory diseases, handicap, pregnancy, mental disorders, systolic blood pressure > 200 mmHg, or diastolic blood pressure > 110 mmHg), (b) residents with contraindications to body composition analyzer measurement (e.g., people with pacemakers, artificial metal joints, and amputated hands or feet) and residents who cannot stand during testing, and (c) residents with habits or lifestyles that may affect HRV (e.g., smoking or alcohol abuse and shift work).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise
the exercise consists of two different modalities: moderate-intensity continuous training (MICT): the main MICT program will be designed to last 30 minutes. The MICT will be designed to involve core muscle training (e.g., march, step touch, lunge, V-step, box step, twist, knee up, scoop, and scissors). high-intensity interval training (HIIT): The HIIT motions will be a mix of spiderman mountain climbers, standing oblique crunches, squats, froggers, jumping jacks, foot fire, jump squats, and mountain climbers. A total of four sets will be performed with 1-minute rests between sets. Each set comprises eight motions, with each motion lasting 30 seconds and a rest interval of 10 seconds between motions. Participants in the HIIT group will perform the most repetitions possible within 30 seconds.

Locations

Country Name City State
Taiwan National Tainan Junior College of Nursing Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Tainan Junior College of Nursing

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary visceral adipose tissue explore which modality of exercise can reduce the greatest area of visceral adipose tissue under body compostion analyzer measurement four times (baseline, 8-week, 16-week, 24-week)
Secondary heart rate variability explore the trajectory of heart rate variability among two groups of exercise four times (baseline, 8-week, 16-week, 24-week)
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