UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057053 |
|---|---|
| Receipt number | R000065207 |
| Scientific Title | Effect and Mechanism of Different Training Intensities on Metabolic Control in Individuals with Diverse Metabolic Abnormalities |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/03/24 22:52:02 |
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Basic information
Public title
Effect and Mechanism of Different Training Intensities on Metabolic Control in Individuals with Diverse Metabolic Abnormalities
Acronym
EMDTI-Metab
Scientific Title
Effect and Mechanism of Different Training Intensities on Metabolic Control in Individuals with Diverse Metabolic Abnormalities
Scientific Title:Acronym
EMDTI-Metab
Region
| Asia(except Japan) |
Condition
Condition
Open public recruiting
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to explore the effectiveness and mechanisms of different exercise prescriptions for metabolic syndrome in the elderly, providing experimental research evidence for the development and clinical application of safe, efficient, personalized, and quantified exercise prescriptions tailored to the elderly population with metabolic syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures of this study include waist circumference, blood pressure, blood sugar, triglyceride, high-density lipoprotein cholesterol.
Key secondary outcomes
Blood indicators, Timed Up and Go Test (TUGT), Short Physical Performance Battery (SPPB), muscle mass, muscle strength, 4-meter walking speed, 6-minute walk distance, dietary nutrition and sleep status, physical activity levels, and changes in maximal oxygen uptake.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High-intensity interval training will be done three times a week on a cycle ergometer under supervision at the research facility for 12 weeks. Each high-intensity interval training exercise session consisted of two 8-minute training sessions, totaling 16 minutes, including 16 repetitions of 30 s high-intensity intervals at 80-100% peak power output interspersed with 30 s active recovery intervals at 25% peak power output. Passive recovery of 4 minutes is given between sessions. A 2-minute warm-up at 50% peak power output is set before the high-intensity interval training session and concludes with a 2-minute cooldown at 25%peak power output
Interventions/Control_2
Each moderate-intensity continuous training is conducted 3 times per week for 12 weeks under supervision. The moderate-intensity continuous training intervention consisted of 2 repetitions of 18-minute continuous aerobic training phases at an intensity of 40-70% heart rate reserve. 4-minute passive recovery intervals between sessions. There is a 2-minute warm-up before exercise at an intensity less than 40% heart rate reserve and a 2-minute cooldown after exercise at an intensity less than 60% heart rate reserve.
Interventions/Control_3
The control group does not receive exercise intervention and keeps their usual physical activity and eating habits.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who meet the diagnostic criteria for metabolic abnormality, including one of hypertension, diabetes, hyperlipidemia, obesity, and hyperuricemia.
Sedentary behavior, at least 3 days per week, 30 minutes per day, with moderate-intensity physical activity for 3 months.
Subjects are willing to participate and can sign an informed consent form.
Key exclusion criteria
Patients who are unable to cooperate in completing exercise intervention, such as those with motor dysfunction caused by neurological diseases, musculoskeletal system diseases, severe organ diseases, and other exercise contraindications;
Patients with weight and glucose abnormality caused by any major chronic diseases, such as chronic kidney disease, systemic lupus erythematosus, chronic hepatitis, hypothyroidism and so on;
Patients with unstable conditions, such as those with resting systolic blood pressure more than 200 mmHg or diastolic blood pressure more than 110 mmHg or recent frequent hypoglycemic events (not more than 4 mmol/L);
Participants who decline participation in the program management or who have not signed the informed consent;
Participants who are currently participating in other trials that may affect the results of this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Qi |
| Middle name | |
| Last name | Guo |
Organization
Shanghai University of Medicine and Health Sciences
Division name
China
Zip code
201318
Address
279 Zhouzhu highway , Pudong New District, Shanghai
TEL
15620467578
guoqijp@gmail.com
Public contact
Name of contact person
| 1st name | Pingping |
| Middle name | |
| Last name | Cai |
Organization
Shanghai University of Medicine and Health Sciences
Division name
China
Zip code
201318
Address
279 Zhouzhu highway , Pudong New District, Shanghai
TEL
18759983881
Homepage URL
caipping9@163.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shanghai University of Medicine and Health Sciences
Address
279 Zhouzhu highway , Pudong New District, Shanghai
Tel
15620467578
guoqijp@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Shanghai University of Medicine and Health Sciences
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065207
