- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05215275
Comparison of Different Exercise Trainings on Heart Rate Variability
Comparison of Different Exercise Trainings on Heart Rate Variability in Community Residents With Higher Visceral Adipose Tissue
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan, 700
- National Tainan Junior College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MICT to HIIT
participants will receive moderate-intensity continuous training lasting 8 weeks, and then exchange to high-intensity interval training lasting 8 weeks, with 8 weeks rest insert to two different modalities of exercise.
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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. |
|
Experimental: HIIT to MICT
participants will receive high-intensity interval training lasting 8 weeks, and then exchange to moderate-intensity continuous training lasting 8 weeks, with 8 weeks rest insert to two different modalities of 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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visceral adipose tissue
Time Frame: four times (baseline, 8-week, 16-week, 24-week)
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explore which modality of exercise can reduce the greatest area of visceral adipose tissue under body compostion analyzer measurement
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four times (baseline, 8-week, 16-week, 24-week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart rate variability
Time Frame: four times (baseline, 8-week, 16-week, 24-week)
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explore the trajectory of heart rate variability among two groups of exercise
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four times (baseline, 8-week, 16-week, 24-week)
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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
Other Study ID Numbers
- 109-516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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