- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06301243
Molecular Signature of Inactivity Induced Exercise Responsiveness
March 6, 2024 updated by: Kevin Gries, Concordia University Wisconsin
Fitness is one of the best predictors for heart and brain disease.
To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard.
These exercise guides are pretty effective, however not everyone will get the same results.
What individuals do outside of the exercise bout can influence the effectiveness of exercise.
One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking".
Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day).
This is important in that exercise may not be able to fully offset these times of inactivity.
However, these studies were only looking at different fats in the blood.
As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise.
This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise?
and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise?
The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps).
Subjects will then come in the next day to bike somewhat hard for 1 hour.
The investigators will take blood samples before, during, and after exercise to measure energy sources.
The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise.
This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin J Gries, PhD
- Phone Number: 262-243-4293
- Email: kevin.gries@cuw.edu
Study Locations
-
-
Wisconsin
-
Mequon, Wisconsin, United States, 53092
- Recruiting
- Kevin J Gries
-
Contact:
- Kevin J Gries, PhD
- Phone Number: 262-243-4293
- Email: kevin.gries@cuw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- free from acute or chronic illness (cardiac, pulmonary, liver, or kidney abnormalities, cancer, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other known metabolic disorders)
- free from orthopedic limitations (including any artificial joints) no known lidocaine allergy
- do not currently smoke or participate in other forms of tobacco use.
- not currently in a structured exercise program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inactive
Subjects will be asked to be sedentary prior to an acute exercise bout (<5,000 steps as measured by a physical activity monitor).
|
Low physical activity level prior to the exercise intervention.
Other Names:
|
Placebo Comparator: Normal activity
Subjects will be asked to have normal activity prior to an acute exercise bout (>8,500 steps as measured by a physical activity monitor).
|
Low physical activity level prior to the exercise intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating lipid and carbohydrate metabolism
Time Frame: Baseline; 20 and 40, and 60 minutes into exercise; and every 30 minutes after exercise up to 4 hours
|
Investigate the role of sex and inactivity on lipid and carbohydrate metabolism following a bout of aerobic exercise.
|
Baseline; 20 and 40, and 60 minutes into exercise; and every 30 minutes after exercise up to 4 hours
|
Basal and post-exercise gene expression with inactivity
Time Frame: Baseline; 4 hours after exercise
|
Study the role of inactivity on basal and exercise-induced gene expression in skeletal muscle.
|
Baseline; 4 hours after exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 29, 2024
First Submitted That Met QC Criteria
March 6, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FY24-62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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