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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04830059
Other study ID # THU2021
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date July 10, 2021

Study information

Verified date April 2021
Source Tsinghua University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double-blind randomized controlled trial design is used in this study. A mixed design of 2 (pollution reduction group vs. no pollution reduction group) × 3 (high intensity intermittent exercise [HIIT], moderate intensity of aerobic exercise [MICT] and control group [CONT]) is used. 93 subjects recruited by advertising will be randomly divided into 6 groups: high intensity exercise group (pollution reduction vs no pollution reduction), moderate intensity aerobic exercise group (pollution reduction vs no pollution reduction) and Stretching group (Control) (pollution reduction vs no pollution reduction).


Description:

Environmental intervention program In the pollution reduction groups, the air purification system is used 2 hours before the subjects entered the room to minimize the indoor PM2.5 and PM10. Exercise intervention program including HIIT, MICT and Stretching (Control) group : The VO2max of all subjects are measured one week before the experiment. HIIT program: 20 minutes exercise of HIIT (1min of 100% VO2max and 1min of 50% VO2max alternately) and 10 minutes of warm-up and relaxation. MICT program: 20 minutes exercise of 70-75% VO2max and 10 minutes of warm-up and relaxation. Stretching control group: 30 minutes of stretching, posture adjustment and rehabilitation courses taught by professional therapists.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 93
Est. completion date July 10, 2021
Est. primary completion date June 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - No regular exercise in the past six months; - Healthy people without history of disease; - Aged between 20 and 30 years old. Exclusion Criteria: - Professional athletes; - Regular exercise in the past six months; - People who are injured or have a history of disease in the past six months; - People who have a history of taking medicine in the past six months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Two types of exercise intervention and control group
Air purification
Air purification in order to reduce the PM2.5 and PM10

Locations

Country Name City State
China Tsinghua University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of cognitive function Cognitive function measured by computer-based tasks including executive function Before and after acute exercise (about 30 minutes).
Primary Change of biomarkers The cognitive-related biomarkers including brain derived neurotrophic factor Before and after acute exercise (about 30 minutes).
Primary Change of oxyhemoglobin Mearsurement of oxyhemoglobin using fNIRS Before and after acute exercise (about 30 minutes).
Primary Change of transcriptions The molecular response of exercise and environment through the measurement of peripheral blood Before and after acute exercise (about 30 minutes).
Primary Change of metabonomics The molecular response of exercise and environment through the measurement of peripheral blood Before and after acute exercise (about 30 minutes).
Primary Change of cerebral blood flow The blood flow of middle cerebral artery measured by ultrasonic doppler Before and after acute exercise (about 30 minutes).
Secondary Change of cognitive function Cognitive function measured by computer-based tasks including executive function Three months (from baseline to the third month)
Secondary Change of aerobic capacity The aerobic capacity measured by the gas metabolism analyzer Three months (from baseline to the third month)
Secondary Change of cerebral blood flow The blood flow of middle cerebral artery measured by ultrasonic doppler Three months (from baseline to the third month)
Secondary Change of biomarkers The cognitive-related biomarkers including brain derived neurotrophic factor Three months (from baseline to the third month)
Secondary Change of oxyhemoglobin Mearsurement of oxyhemoglobin using functional near infrared spectroscopy Three months (from baseline to the third month)
Secondary Change of metabonomics The molecular response of exercise through the measurement of peripheral blood Three months (from baseline to the third month)
Secondary Change of transcriptions The molecular response of exercise through the measurement of peripheral blood Three months (from baseline to the third month)
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