Developing a Physiological Understanding of High Duration Activity

NCT ID: NCT05135234

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

Physical activity/inactivity will be carefully measured with objective devices. Wearable devices most commonly include accelerometers capable of capturing various types of movement and body posture. The intensity of muscle activation (the soleus and other leg muscles) will be measured in some participants in the developmental studies with EMG, with the limb motion quantified with goniometry. Skeletal muscle and whole body metabolism will be evaluated, especially after isolated local contractile activity focusing on the slow oxidative soleus muscle. Blood chemistry will also be investigated in this comprehensive series of studies to understand how replacing sedentary time with low effort muscular activity can be enhanced. Glycemia will be evaluated in the postprandial period in the morning after an overnight fast when there can be standardized control of carbohydrate ingestion. This includes a standardized oral glucose tolerance test with careful experimental assessment of posture and muscular recruitment during the testing periods. One phase of this study is particularly interested in assessing the acute responses that occur immediately as a result of contractile activity, while also evaluating in another phase how this may be impacted by a change in the sedentary lifestyle. This includes assessing new approaches for improving metabolism throughout the day by reducing the amount of time sitting inactive (i.e. sedentary time). Importantly, because the potential immediate benefits of muscle contractile activity are directly dependent on the duration of activity, the investigators aim to develop in a series of experiments how much muscular activity time can be performed comfortably and safely by anybody instead of sitting inactive with low muscle metabolism regardless of age, fitness, body type, and other conditions commonly limiting effectiveness of traditional exercise prescriptions.

Conditions

Sedentary Lifestyle; Hyperinsulinemia; Glucose Tolerance Impaired; Low-density-lipoprotein-type; Aging Problems; Lipid Metabolism Disorders; Inactivity, Physical; Metabolic Disorder, Glucose

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Muscular Exercise

Increased level of low effort muscular activity

Group Type: EXPERIMENTAL

Muscular Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Muscular Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Marc Hamilton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc T Hamilton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

University of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

University of Houston

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15463-01

Identifier Type: -

Identifier Source: org_study_id