Life StylePACENCT05838508
Effect of Physical Activity Pattern on Cardiometabolic Health
A study testing Exercise intervention in people with Life Style, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Style
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jingyi Qian, PhD, 6175257423, jqian@bwh.harvard.edu
Vy Nguyen, B.S., 617-525-0662, vnguyen42@bwh.harvard.edu
About this study
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
Read the 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.
- Conditions
- Life Style
- Being tested
- Exercise intervention
- Keywords
- exercise, circadian system, physical activity, glucose tolerance, blood pressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Research participants will be assigned to two exercise conditions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise A-B Intervention | Experimental | The Exercise A first, then the Exercise B intervention. Receives: Behavioral: Exercise intervention |
| Exercise B-A Intervention | Experimental | The Exercise B first, then the Exercise A intervention. Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose level
mean glucose level after exercise session
Measured: 24-hour test period after exercise
mean arterial pressure
mean arterial pressure after exercise session
Measured: 24-hour test period after exercise
Secondary outcomes (4)
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
Measured: 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
Measured: about 12 and 24 hours after exercise
total peripheral resistance
total peripheral resistance derived from BP waveform measured by finger plethysmography
Measured: 24-hour test period after exercise
autonomic nervous system activity
derived by time-domain heart rate variability analysis
Measured: 24-hour test period after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start11 Oct 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life StyleStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jingyi Qian, Brigham and Women's Hospital
- Investigators
- Jingyi Qian, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838508
- Sponsor's protocol ID
- 2023P001025
- Other IDs
- R00HL148500
- Acronym
- PACE
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity Pattern on Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT05838508
- Acronym / sponsor ID
- PACE / 2023P001025
- Conditions
- Life Style
- Keywords
- exercise, circadian system, physical activity, glucose tolerance, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise A-B Intervention | Experimental | Behavioral: Exercise interventionThe Exercise A first, then the Exercise B intervention. |
| Exercise B-A Intervention | Experimental | Behavioral: Exercise interventionThe Exercise B first, then the Exercise A intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionResearch participants will be assigned to two exercise conditions. | Behavioural | Exercise A-B Intervention, Exercise B-A Intervention |
Primary outcome
glucose level
Time frame: 24-hour test period after exercise
mean glucose level after exercise session
mean arterial pressure
Time frame: 24-hour test period after exercise
mean arterial pressure after exercise session
4 secondary outcomes
insulin sensitivity index
Time frame: about 12 and 24 hours after exercise
beta-cell function index
Time frame: about 12 and 24 hours after exercise
total peripheral resistance
Time frame: 24-hour test period after exercise
autonomic nervous system activity
Time frame: 24-hour test period after exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Life Style
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
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Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
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Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingyi Qian, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Life Style, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Qian, PhD (6175257423, jqian@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose level (time frame: 24-hour test period after exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.