Effect of Physical Activity Pattern on Cardiometabolic Health
PACE
2 other identifiers
interventional
26
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
June 13, 2025
June 1, 2025
1.9 years
April 7, 2023
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
insulin sensitivity index
about 12 and 24 hours after exercise
beta-cell function index
about 12 and 24 hours after exercise
total peripheral resistance
24-hour test period after exercise
autonomic nervous system activity
24-hour test period after exercise
Other Outcomes (2)
resting energy expenditure
24-hour test period after exercise
respiratory exchange ratio
24-hour test period after exercise
Study Arms (2)
Exercise A-B Intervention
EXPERIMENTALThe Exercise A first, then the Exercise B intervention.
Exercise B-A Intervention
EXPERIMENTALThe Exercise B first, then the Exercise A intervention.
Interventions
Research participants will be assigned to two exercise conditions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingyi Qian, PhD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
April 7, 2023
First Posted
May 1, 2023
Study Start
October 11, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share