NCT06609785

Brief Summary

Aims/hypothesis: Both continuous aerobic training (CAT) and high intensity interval training (HIIT) are recommended to promote health and prevent diseases. Exercise-induced circulating extracellular vesicles (EX-EVs) have been suggested to play essential roles in mediating organ crosstalk, but corresponding molecular mechanisms remain largely unexplored. We aimed to assess and compare the systemic effects of CAT and HIIT via multi-omics integration analysis of EX-EVs. Methods: Five healthy male volunteers were assigned to HIIT (20 minutes of cycling with periods of 2 minutes at 80-95% HRmax separated by 2 minutes of active recovery) and CAT (20 minutes of cycling at 60-80% of HRmax), with a 7-day interval between sessions. Plasma EVs were collected at rest or immediately after each training section, prior to proteomics and miRNA profile analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

September 19, 2024

Last Update Submit

September 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • miRNA and proteins in human plasma-derived extracellular vesicles

    Measuring miRNA and proteins in human plasma-derived extracellular vesicles through high-throughput sequencing

    From enrollment to the end of intervention at 2 weeks

Study Arms (1)

exercise training group

EXPERIMENTAL

All volunteers had a standardized breakfast, and all tests started at 9:00 a.m. The volunteers successively completed both high intensity interval training (HIIT) and continuous aerobic training (CAT) under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group. A real-time heart rate monitoring system was continuously used during each training session.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

The volunteers successively completed both high intensity interval training (HIIT)and continuous aerobic training (CAT) under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group.

exercise training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age Body mass index (BMI) values between 18-28 kg/m2 More than 3 h of physical activity per week Acknowledgment of informed consent.

You may not qualify if:

  • Smokers Body weight change \>5 kg in 6 months Unsuitable for physical training (heart disease, respiratory disorders or any conditions that could be aggravated by exercise) Currently taking medication or having a history of medication such as steroids, beta-blockers or anticoagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Metabolism, Research Center for Islet Transplantation, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Diabetes MellitusMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Per-Olof Berggren

    Department of Molecular Medicine and Surgery, Karolinska Institutet, SE-17177 Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 24, 2024

Study Start

June 1, 2022

Primary Completion

July 15, 2022

Study Completion

September 1, 2022

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

all collected IPD, all IPD that underlie results in a publication

Time Frame
Beginning 1 year and ending 3 years after publication
Access Criteria
Any researchers who has undergone an approval process will be able to access the IPD and supporting information, Applicants are required to submit a data use application via the following email( yrou2001@163.com ),including the research plan and other relevant documents. Once approved , the applicant will receive the data via a secure file transfer method.

Locations