NCT05135234

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

9.3 years

First QC Date

April 16, 2019

Last Update Submit

May 18, 2023

Conditions

Keywords

sedentaryphysical activitymuscle contractile activity

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

EXPERIMENTAL

Increased level of low effort muscular activity

Behavioral: Muscular Exercise

Interventions

Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity

Muscular Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorHyperinsulinismGlucose IntoleranceLipid Metabolism DisordersGlucose Metabolism DisordersMotor Activity

Condition Hierarchy (Ancestors)

BehaviorMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemia

Study Officials

  • Marc T Hamilton, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

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

Locations