NCT04830059

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) Ă— 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 15, 2025

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

March 29, 2021

Last Update Submit

December 6, 2025

Conditions

ExerciseAir PollutionCognitionHealth Promotion

Outcome Measures

Primary Outcomes (6)

  • Change of cognitive function

    Cognitive function measured by computer-based tasks including executive function

    Before and after acute exercise (about 30 minutes).

  • Change of biomarkers

    The cognitive-related biomarkers including brain derived neurotrophic factor

    Before and after acute exercise (about 30 minutes).

  • Change of oxyhemoglobin

    Mearsurement of oxyhemoglobin using fNIRS

    Before and after acute exercise (about 30 minutes).

  • Change of transcriptions

    The molecular response of exercise and environment through the measurement of peripheral blood

    Before and after acute exercise (about 30 minutes).

  • Change of metabonomics

    The molecular response of exercise and environment through the measurement of peripheral blood

    Before and after acute exercise (about 30 minutes).

  • 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 Outcomes (7)

  • Change of cognitive function

    Three months (from baseline to the third month)

  • Change of aerobic capacity

    Three months (from baseline to the third month)

  • Change of cerebral blood flow

    Three months (from baseline to the third month)

  • Change of biomarkers

    Three months (from baseline to the third month)

  • Change of oxyhemoglobin

    Three months (from baseline to the third month)

  • +2 more secondary outcomes

Study Arms (6)

High intensity intermittent training

EXPERIMENTAL

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

HIIT with pollution reduction

EXPERIMENTAL

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: ExerciseBehavioral: Air purification

Moderate intensity continuous training

EXPERIMENTAL

MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise.

Behavioral: Exercise

MICT with pollution reduction

EXPERIMENTAL

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: ExerciseBehavioral: Air purification

Stretch control group

EXPERIMENTAL

Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist.

Behavioral: Exercise

Control with pollution reduction

EXPERIMENTAL

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: ExerciseBehavioral: Air purification

Interventions

ExerciseBEHAVIORAL

Two types of exercise intervention and control group

Control with pollution reductionHIIT with pollution reductionHigh intensity intermittent trainingMICT with pollution reductionModerate intensity continuous trainingStretch control group
Air purificationBEHAVIORAL

Air purification in order to reduce the PM2.5 and PM10

Control with pollution reductionHIIT with pollution reductionMICT with pollution reduction

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No regular exercise in the past six months;
  • Healthy people without history of disease;
  • Aged between 20 and 30 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsinghua University

Beijing, Beijing Municipality, 100084, China

Location

Related Publications (2)

  • Liu J, Min L, Liu R, Zhang X, Wu M, Di Q, Ma X. The effect of exercise on cerebral blood flow and executive function among young adults: a double-blinded randomized controlled trial. Sci Rep. 2023 May 22;13(1):8269. doi: 10.1038/s41598-023-33063-9.

    PMID: 37217511DERIVED

  • Liu J, Zhang Y, Li X, Wang D, Shi B, You Y, Min L, Luo B, Li Y, Di Q, Ma X. Exercise improves mental health status of young adults via attenuating inflammation factors but modalities matter. Front Psychiatry. 2022 Dec 14;13:1067890. doi: 10.3389/fpsyt.2022.1067890. eCollection 2022.

    PMID: 36590621DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Qian Di, Sc.D.

    Wanke School of public health, Tsinghua University

    STUDY DIRECTOR

  • Xindong Ma, PhD

    Department of physical education, Tsinghua University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and investigators are blinded, and part of the outcome assessors are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research staff

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 2, 2021

Study Start

November 1, 2020

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

December 15, 2025

Record last verified: 2021-04

Locations

CN(1)