The Joint Effect of Air Pollution and Exercise on Cognitive Function

Sponsor

Tsinghua University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04830059

Collaborator

(none)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Exercise Air Pollution Cognition Health Promotion	Behavioral: Exercise Behavioral: Air purification	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind randomized controlled trialDouble blind randomized controlled trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants and investigators are blinded, and part of the outcome assessors are blinded.

Primary Purpose:

Treatment

Official Title:

The Joint Effect of Air Pollution and Exercise on Cognitive Function

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Jun 10, 2021

Anticipated Study Completion Date :

Jul 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High intensity intermittent training HIIT exercise program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes.	Behavioral: Exercise Two types of exercise intervention and control group
Experimental: HIIT with pollution reduction HIIT program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.	Behavioral: Exercise Two types of exercise intervention and control group Behavioral: Air purification Air purification in order to reduce the PM2.5 and PM10
Experimental: Moderate intensity continuous training MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise.	Behavioral: Exercise Two types of exercise intervention and control group
Experimental: MICT with pollution reduction MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.	Behavioral: Exercise Two types of exercise intervention and control group Behavioral: Air purification Air purification in order to reduce the PM2.5 and PM10
Experimental: Stretch control group Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist.	Behavioral: Exercise Two types of exercise intervention and control group
Experimental: Control with pollution reduction Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist. Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.	Behavioral: Exercise Two types of exercise intervention and control group Behavioral: Air purification Air purification in order to reduce the PM2.5 and PM10

Outcome Measures

Primary Outcome Measures

Change of cognitive function [Before and after acute exercise (about 30 minutes).]
Cognitive function measured by computer-based tasks including executive function
Change of biomarkers [Before and after acute exercise (about 30 minutes).]
The cognitive-related biomarkers including brain derived neurotrophic factor
Change of oxyhemoglobin [Before and after acute exercise (about 30 minutes).]
Mearsurement of oxyhemoglobin using fNIRS
Change of transcriptions [Before and after acute exercise (about 30 minutes).]
The molecular response of exercise and environment through the measurement of peripheral blood
Change of metabonomics [Before and after acute exercise (about 30 minutes).]
The molecular response of exercise and environment through the measurement of peripheral blood
Change of cerebral blood flow [Before and after acute exercise (about 30 minutes).]
The blood flow of middle cerebral artery measured by ultrasonic doppler

Secondary Outcome Measures

Change of cognitive function [Three months (from baseline to the third month)]
Cognitive function measured by computer-based tasks including executive function
Change of aerobic capacity [Three months (from baseline to the third month)]
The aerobic capacity measured by the gas metabolism analyzer
Change of cerebral blood flow [Three months (from baseline to the third month)]
The blood flow of middle cerebral artery measured by ultrasonic doppler
Change of biomarkers [Three months (from baseline to the third month)]
The cognitive-related biomarkers including brain derived neurotrophic factor
Change of oxyhemoglobin [Three months (from baseline to the third month)]
Mearsurement of oxyhemoglobin using functional near infrared spectroscopy
Change of metabonomics [Three months (from baseline to the third month)]
The molecular response of exercise through the measurement of peripheral blood
Change of transcriptions [Three months (from baseline to the third month)]
The molecular response of exercise through the measurement of peripheral blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tsinghua University	Beijing	Beijing	China	100084

Sponsors and Collaborators

Tsinghua University

Investigators

Study Director: Qian Di, Sc.D., Wanke School of public health, Tsinghua University
Study Chair: Xindong Ma, PhD, Department of physical education, Tsinghua University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianxiu Liu, Research staff, Tsinghua University

ClinicalTrials.gov Identifier:

NCT04830059

Other Study ID Numbers:

THU2021

First Posted:

Apr 2, 2021

Last Update Posted:

Apr 2, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 2, 2021