Metabolic Syndrome XNCT06379204
A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
A study testing the maximum physiological value standardized group and the ventilatory threshold individualized group in people with Metabolic Syndrome X, run by Taiyuan Central Hospital of Shanxi Medical University at 1 site in China.
Trial summary
Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- the maximum physiological value standardized group and the ventilatory threshold individualized group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2022to 19 Sep 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included who met the Chinese Diabetic Society diagnostic criteria for MS-i.e., three or more of the following five items: (i) abdominal obesity (i.e., central obesity) with waist circumference ≥ 90 cm in males and ≥ 85 cm in females; (ii) hyperglycemia defined as fasting blood glucose ≥ 6.1 mmol/L or blood glucose ≥ 7.8 mmol/L two hours after glucose loading, or diagnosis of diabetes mellitus; (iii) hypertension defined as blood pressure ≥ 130/85 mmHg or diagnosed with hypertension; (iv) fasting triglycerides (TG) ≥ 1.70 mmol/L; and (v) fasting high-density lipoprotein cholesterol (HDL-C) \< 1.04 mmol/L.
- Patients were aged 25 to 65 years, with no restrictions on number of males or females.
- Patients exhibited a long-term sedentary lifestyle and did not carry out moderate-intensity physical activity for at least three d/week of 30 min/d duration within three months of the study.
- Patients were willing to participate and sign the informed consent form.
Who cannot join
- Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;
- Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;
- Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and
- Patients with drug modifications during the intervention that could affect the outcome markers.
Trial locations and contacts
1 site in 1 country.
About this study
Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients.
- Conditions
- Metabolic Syndrome X
- Being tested
- the maximum physiological value standardized group, the ventilatory threshold individualized group
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the maximum physiological value standardized groupBehavioural
10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and HRR heart rate reserve method, gradually increasing.
the ventilatory threshold individualized groupBehavioural
10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and three zone threshold model, gradually increasing.
| Study group | Role | What they receive |
|---|---|---|
| the maximum physiological value standardized group | Experimental | Not described Receives: Behavioral: the maximum physiological value standardized group |
| the ventilatory threshold individualized group | Active comparator | Not described Receives: Behavioral: the ventilatory threshold individualized group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Measured: From enrollment to the end of 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start4 Nov 2022
- Primary completion30 Aug 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiyuan Central Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Ruojiang, Taiyuan Central Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379204
- Sponsor's protocol ID
- No.2022026
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
- ClinicalTrials.gov ID
- NCT06379204
- Acronym / sponsor ID
- No.2022026
- Conditions
- Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taiyuan Central Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 23 Apr 2024 (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.
Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the maximum physiological value standardized group | Experimental | Behavioral: the maximum physiological value standardized group |
| the ventilatory threshold individualized group | Active comparator | Behavioral: the ventilatory threshold individualized group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients were included who met the Chinese Diabetic Society diagnostic criteria for MS-i.e., three or more of the following five items: (i) abdominal obesity (i.e., central obesity) with waist circumference ≥ 90 cm in males and ≥ 85 cm in females; (ii) hyperglycemia defined as fasting blood glucose ≥ 6.1 mmol/L or blood glucose ≥ 7.8 mmol/L two hours after glucose loading, or diagnosis of diabetes mellitus; (iii) hypertension defined as blood pressure ≥ 130/85 mmHg or diagnosed with hypertension; (iv) fasting triglycerides (TG) ≥ 1.70 mmol/L; and (v) fasting high-density lipoprotein cholesterol (HDL-C) \< 1.04 mmol/L.
- Patients were aged 25 to 65 years, with no restrictions on number of males or females.
- Patients exhibited a long-term sedentary lifestyle and did not carry out moderate-intensity physical activity for at least three d/week of 30 min/d duration within three months of the study.
- Patients were willing to participate and sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;
- Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;
- Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and
- Patients with drug modifications during the intervention that could affect the outcome markers.
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 |
|---|---|---|
| the maximum physiological value standardized group10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and HRR heart rate reserve method, gradually increasing. | Behavioural | the maximum physiological value standardized group |
| the ventilatory threshold individualized group10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and three zone threshold model, gradually increasing. | Behavioural | the ventilatory threshold individualized group |
Primary outcome
Peak oxygen uptake
Time frame: From enrollment to the end of 12 weeks of treatment
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 26 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the maximum physiological value standardized group and the ventilatory threshold individualized group in people with Metabolic Syndrome X, run by Taiyuan Central Hospital of Shanxi Medical University at 1 site in China.
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 4 inclusion and 4 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 26 Apr 2024. 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 China. 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?
Peak oxygen uptake (time frame: From enrollment to the end of 12 weeks of treatment). 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 26 Apr 2024.