UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054193 |
|---|---|
| Receipt number | R000061879 |
| Scientific Title | Effects and mechanism of mTOR-mediated autophagy induced by different exercise prescriptions in sarcopenia |
| Date of disclosure of the study information | 2024/04/18 |
| Last modified on | 2024/10/21 13:09:35 |
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Basic information
Public title
Effects and mechanism of mTOR-mediated autophagy induced by different exercise prescriptions in sarcopenia
Acronym
EMMA-SARC
Scientific Title
Effects and mechanism of mTOR-mediated autophagy induced by different exercise prescriptions in sarcopenia
Scientific Title:Acronym
EMMA-SARC
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 sarcopenia 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 sarcopenia.
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 muscle mass, muscle strength, 4-meter walking speed, and the longitudinal changes in mTOR and autophagy assessed at four time points.
Key secondary outcomes
Blood indicators, Timed Up and Go Test (TUGT), Short Physical Performance Battery (SPPB), 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
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Low-intensity aerobic exercise group: Starting with a power bicycle, and subsequently allowing subjects to choose aerobic exercise training equipment according to their personal preferences, such as a treadmill, elliptical trainer, or a four-limb linkage trainer, with each session aiming to burn 150 kcal. The low-intensity aerobic exercise group engages in activities at 50-55% of their peak oxygen uptake rate.
Interventions/Control_2
High-intensity aerobic exercise group: Starting with a power bicycle, and then allowing subjects to choose from a treadmill, elliptical machine, or a four-limb linkage trainer based on their personal preferences for aerobic exercise training equipment, with each session designed to expend 150 kcal. The high-intensity aerobic exercise group performs at 70-75% of their peak oxygen uptake.
Interventions/Control_3
Resistance exercise group: Six types of weightlifting exercises for both upper and lower body parts, where subjects can choose two types of equipment for the upper body and two for the lower body based on their preference for strength training. The resistance is set at 60-70% of the subject's one-repetition maximum for each exercise movement. Each set consists of 8 repetitions, followed by 2 sets per movement. After completing one set, there is a rest period of 2-3 minutes before proceeding to the next exercise.
Interventions/Control_4
Control group: no exercise intervention
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Conforming to the diagnostic criteria for sarcopenia in the elderly as established by the Asian Working Group for Sarcopenia (AWGS), having signed an informed consent form, and being in a stable state of chronic disease.
Key exclusion criteria
Patients with conditions affecting muscles and bones, such as renal failure, cancer, stroke, severe liver disease, diabetes, thyroid or parathyroid disorders; on medications like glucocorticoids, sex hormones, thyroid hormones; with severe heart conditions, cognitive or psychiatric impairments, cancer, joint contractures, metal implants, or severe disabilities; had recent major surgeries or refuse to consent to the study management are excluded.
Target sample size
210
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 | Kai |
| Middle name | |
| Last name | Zheng |
Organization
Shanghai University of Medicine and Health Sciences
Division name
China
Zip code
201318
Address
279 Zhouzhu highway , Pudong New District, Shanghai
TEL
18059820478
Homepage URL
zhengkai0003@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
| 2024 | Year | 04 | Month | 18 | 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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061879
