Effect of Physical Activity Pattern on Cardiometabolic Health (PACE)

The goal of this study is to understand the interaction between the circadian system and physical activity.

Participants will:

• complete 2 inpatient stays
• perform moderate exercise
• be provided with identical meals
• have frequent blood draws
• provide urine and saliva samples

Study Overview

• Status: Recruiting
• Conditions: Life Style
• Intervention / Treatment: Behavioral: Exercise intervention

Detailed Description

The endogenous circadian system (i.e., an internal biological rhythm) plays an important role in regulating blood glucose, blood pressure, and energy expenditure. Physical activity improves health and reduces the risk for cardiovascular diseases and type 2 diabetes. The goal of this study is to understand the interaction between the circadian system and physical activity. We aim to test whether such relationship between the circadian system and physical activity can be used to enhance the health benefits of physical activity.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyi Qian, PhD; Phone Number: 6175257423; Email: jqian@bwh.harvard.edu
• Study Contact Backup: Name: Vy Nguyen, B.S.; Phone Number: 617-525-0662; Email: vnguyen42@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jingyi Qian, PhD; Phone Number: 6175257423; Email: jqian@bwh.harvard.edu
      • Sub-Investigator: Frank Scheer, PhD
      • Principal Investigator: Jingyi Qian, PhD
      • Contact: Vy Nguyen, B.S.; Phone Number: 617-525-0662; Email: vnguyen42@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-45 yr old
• Body mass index (BMI) 18.5 - 34.9 kg/m2
• No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
• Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

• Currently smoking/vaping or 5 or more years of smoking/vaping
• Currently pregnant or breastfeeding
• History of drug or alcohol dependency
• History of psychiatric illness or disorder
• Any hospitalization due to COVID-19
• Inability to exercise for any reason
• Any known contraindication to exercise testing based on current ACSM guidelines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise A-B Intervention; The Exercise A first, then the Exercise B intervention.	Behavioral: Exercise intervention; Research participants will be assigned to two exercise conditions.
Experimental: Exercise B-A Intervention; The Exercise B first, then the Exercise A intervention.	Behavioral: Exercise intervention; Research participants will be assigned to two exercise conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose level	mean glucose level after exercise session	24-hour test period after exercise
mean arterial pressure	mean arterial pressure after exercise session	24-hour test period after exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin sensitivity index	Oral Minimal Model method estimates mean insulin sensitivity based on blood glucose and insulin levels from two mixed meal tests after exercise session	about 12 and 24 hours after exercise
beta-cell function index	Oral Minimal Model method estimates mean beta-cell function based on blood glucose, insulin and c-peptide levels from two mixed meal tests after exercise session	about 12 and 24 hours after exercise
total peripheral resistance	total peripheral resistance derived from BP waveform measured by finger plethysmography	24-hour test period after exercise
autonomic nervous system activity	derived by time-domain heart rate variability analysis	24-hour test period after exercise

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
resting energy expenditure	energy expenditure will be measured at 1-2 hours interval by indirect calorimetry	24-hour test period after exercise
respiratory exchange ratio	respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry	24-hour test period after exercise

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jingyi Qian, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; exercise; blood pressure; glucose tolerance; circadian system
• Other Study ID Numbers: 2023P001025; R00HL148500 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No