Fat BurnNCT05215275
Comparison of Different Exercise Trainings on Heart Rate Variability
A study testing exercise in people with Fat Burn and Exercise, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Exercise Trainings on Heart Rate Variability in Community Residents With Higher Visceral Adipose Tissue
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.
Read the 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.
- Being tested
- exercise
- Keywords
- heart rate variability, visceral adipose tissue, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MICT to HIIT | Experimental | 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. Receives: Behavioral: exercise |
| HIIT to MICT | Experimental | 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. Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral adipose tissue
explore which modality of exercise can reduce the greatest area of visceral adipose tissue under body compostion analyzer measurement
Measured: four times (baseline, 8-week, 16-week, 24-week)
Secondary outcomes (1)
heart rate variability
explore the trajectory of heart rate variability among two groups of exercise
Measured: four times (baseline, 8-week, 16-week, 24-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start21 Jan 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsuan Chang, National Tainan Junior College of Nursing
- Investigators
- Yu-Hsuan Chang, phD, Principal investigator, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215275
- Sponsor's protocol ID
- 109-516
- Status last verified
- May 2025
- First submitted
- 19 Jan 2022
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Exercise Trainings on Heart Rate Variability in Community Residents With Higher Visceral Adipose Tissue
- ClinicalTrials.gov ID
- NCT05215275
- Acronym / sponsor ID
- 109-516
- Keywords
- heart rate variability, visceral adipose tissue, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICT to HIIT | Experimental | Behavioral: exerciseparticipants 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. |
| HIIT to MICT | Experimental | Behavioral: exerciseparticipants 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisethe 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. | Behavioural | HIIT to MICT, MICT to HIIT |
Primary outcome
visceral adipose tissue
Time frame: four times (baseline, 8-week, 16-week, 24-week)
explore which modality of exercise can reduce the greatest area of visceral adipose tissue under body compostion analyzer measurement
1 secondary outcome
heart rate variability
Time frame: four times (baseline, 8-week, 16-week, 24-week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsuan Chang, phD principal investigator
National Tainan Junior College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Fat Burn and Exercise, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visceral adipose tissue (time frame: four times (baseline, 8-week, 16-week, 24-week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.