Developing a Physiological Understanding of High Duration Activity
Adaptive Effects of Very Light Physical Activity on Metabolism
2 other identifiers
interventional
60
1 country
1
Brief Summary
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging. From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day). Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time. This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement. There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Longer than P75 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
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 19, 2023
May 1, 2023
9.3 years
April 16, 2019
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Oxygen cost of isolated muscle contractions
The energetics of isolated muscle contractions will be described relative to the distinct biomechanics of different types of muscular movement
Acute contractile activity (at least 3 minutes)
Fatigue time during muscle group specific contractile activity
Determinants of muscular endurance as a function of recruitment intensity
Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
Change in postprandial glucose regulation
Glucose concentration response during the postprandial period after an oral glucose tolerance test
The change through the completion of the postprandial period, an average of 180 minutes
Change in very low density lipoprotein (VLDL) - Triglyceride
The concentration of triglyceride in the plasma VLDL lipoprotein
The change through the completion of an acute fasting period, approximately 8-12 hours
The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Throughout the waking day (~16 hours).
Angiopoietin-like protein 4
One of the molecular determinants of lipoprotein lipase regulation
The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
Secondary Outcomes (12)
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
During acute contractile activity of at least 3 minutes
Electrical activity of muscle, Electromyography (EMG)
At least 3 minute recording periods
Local rate of oxygen consumption of working muscle
Steady-state measurements taken for ~6 continuous minutes of contractile activity
The ratio of carbohydrate vs. fat oxidation
Acute responses within less than 24 hours.
Plasma insulin change
The change through the completion of the postprandial period, an average of 180 minutes
- +7 more secondary outcomes
Study Arms (1)
Muscular Exercise
EXPERIMENTALIncreased level of low effort muscular activity
Interventions
Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
Eligibility Criteria
You may qualify if:
- Age must be 18 years or older
- Able to fast overnight
- Can maintain diet, medications, and sleep habits between each of the testing visits.
- Lifestyle is consistent with participation in a study evaluating reductions of inactivity (defined by sitting at a low metabolic rate because of minimal muscular activity)
- Willing and able to wear small wearable activity monitors under their clothes as instructed.
- No plans to start a new diet or exercise program if enrolled in the present study.
You may not qualify if:
- Practical barriers to completing the study, such as plans to move, or work, or family commitments.
- Plans to change lifestyle during the present study.
- Have physical, vocational, or reasons that prohibit ordinary sitting behaviors present in the modern world.
- Currently dieting to change body weight, or have eating disorder.
- Are pregnant or plan to become pregnant.
- Taking medications that affect bleeding (ie anticoagulants).
- Allergy to lidocaine excludes biopsy component of study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Houstonlead
- American Diabetes Associationcollaborator
Study Sites (1)
University of Houston
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc T Hamilton, Ph.D.
University of Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 16, 2019
First Posted
November 26, 2021
Study Start
August 1, 2016
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share