Reduced Physical Activity for Sedentary Lifestyle

Overseen By Paul Reidy, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Miami University

Must not be taking: Acetaminophen, Aspirin

Disqualifiers: Injury, Cancer, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a short period of reduced physical activity affects blood sugar control and blood vessel function. Researchers aim to understand how individuals with varying fitness levels and body types recover their blood sugar control after a week of reduced activity. Participants will first maintain their usual activity, then reduce their physical activity by at least 2,000 steps, and finally return to their normal activity levels. The study seeks men and women aged 18-40 who are generally active, have maintained a stable weight for at least a year, and can safely ride an electric scooter. As an unphased trial, it offers participants the opportunity to contribute to valuable research on lifestyle impacts on health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take more than 500mg of vitamins daily or use acetaminophen or aspirin during the study.

What prior data suggests that this protocol is safe?

Research has shown that insufficient physical activity can lead to several health problems. People who are less active have a 20% to 30% higher risk of early death compared to those who remain active. Excessive sitting and insufficient movement can also increase the risk of heart disease, type 2 diabetes, and obesity, which can make life more difficult and shorter.

In this trial, participants will experience a week of reduced activity, moving less than usual and using electric scooters instead of walking. This change is temporary. The researchers aim to observe how this affects the body's ability to control blood sugar and how quickly participants recover when they return to normal activity levels.

This trial does not involve any new drugs or medical treatments; it only involves altering the amount of movement. Since the focus is on normal activities rather than new treatments, there is no evidence of direct harm from the trial itself. However, prolonged inactivity is generally not beneficial for health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an unconventional approach to understanding the impact of reduced physical activity on health, particularly glucose levels. Unlike standard interventions that emphasize increasing physical activity to combat sedentary lifestyles, this trial temporarily reduces activity using seated electric scooters to replace walking. This unique method could reveal new insights into how decreased movement affects metabolic health, potentially leading to innovative strategies for managing sedentary behaviors.

What evidence suggests that reduced physical activity impacts glucose control and vascular function?

Research has shown that insufficient physical activity can harm health by increasing the risk of diseases like heart disease and diabetes. Studies have found that people who don't exercise regularly face a 20% to 30% higher risk of dying compared to those who do. Excessive sitting can impair the body's ability to control sugar levels, affecting blood flow and heart health. The current trial aims to understand how fitness levels and body fat influence recovery after inactivity. Early findings suggest that individuals who are less fit or have more body fat may struggle more to normalize sugar levels after a period of inactivity. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women with varying levels of fitness and body fat. It's designed to see how these factors affect blood sugar control after a period of reduced physical activity (like sitting too much). Participants should be generally healthy but may have different exercise habits or weights.

Inclusion Criteria

Active (>7000 steps per day, walking > 1 mile a day outside)

Stable body weight for at least 1 year

Aerobic fitness level, CRF is < 9 and >14 METS

Exclusion Criteria

Any injury preventing them from exercising regularly at the time of the screening

My cancer is currently active.

Implantable defibrillator or pacemaker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Normal Physical Activity

Participants maintain their normal level of physical activity

1 week

Continuous monitoring

Reduced Physical Activity

Participants reduce their physical activity by at least 2000 steps per day using strategies such as seated electric scooters

1 week

Continuous monitoring

Resumption of Normal Physical Activity

Participants resume their normal physical activity levels

1 week

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Reduced Physical Activity

Trial Overview

The study looks at how a week of normal activity, followed by a week of less movement, and then another week back to normal affects blood sugar and blood vessel health. Researchers will use continuous glucose monitoring and tests that measure the body's response to sugar intake.

How Is the Trial Designed?

Group I: Reduced physical activity Experimental Treatment 1 Intervention

We will recruit, screen, and enroll eligible participants (18-40y) across the following four groups: high CRF/low adiposity, high CRF/high adiposity; low CRF/low adiposity; low CRF/high adiposity. Each participant will undergo a three-week study. For the first week, participants will be instructed to maintain their normal level of physical activity. For the second week, participants' schedules will be examined, and strategies designed to reduce steps (by at least 2000 steps) and physical activity. To assist in reducing walking and increased sitting, participants will be given seated electric scooters to use whenever they normally walk. The scooters will be returned on the third week, and participants will be instructed to resume their normal physical activity. During the entire three weeks, participants will wear a continuous glucose monitor and a physical activity monitor.

Who Is Running the Clinical Trial?

Miami University

Lead Sponsor

Trials

16

Recruited

3,000+

Published Research Related to This Trial

The individualized motivational counseling intervention led to a decrease in sitting time by an average of 0.27 hours per day among participants, although this change was not statistically significant compared to the control group.

Participants in the intervention group showed significant improvements in cardiometabolic health markers, including a reduction in fasting serum insulin, insulin resistance, and waist circumference, suggesting potential health benefits despite the lack of a significant reduction in sitting time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational counseling to reduce sitting time: a community-based randomized controlled trial in adults. Aadahl, M., Linneberg, A., Møller, TC., et al.[2018]

In a study of 808 participants at high risk for type 2 diabetes, reallocating 30 minutes from sedentary behavior to light-intensity physical activity (LPA) led to significant reductions in waist circumference and glucose levels, indicating improved cardiometabolic health.

The most substantial benefits were observed when reallocating 30 minutes from sedentary behavior to moderate-to-vigorous intensity physical activity (MVPA), which resulted in greater reductions in waist circumference and glucose levels, highlighting the importance of higher intensity activities for health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospectively Reallocating Sedentary Time: Associations with Cardiometabolic Health. Yates, T., Edwardson, CL., Henson, J., et al.[2021]

Excessive sedentary behavior, which accounts for 50-70% of waking hours, is an independent risk factor for various health issues, including obesity, diabetes, and cardiovascular problems.

Taking short breaks to walk during prolonged sitting can help mitigate the negative health effects of sedentary behavior, making it important to reduce overall sitting time or incorporate 'activity snacks' throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A PARADIGM SHIFT IN THE PERCEPTION OF HEALTH MAINTENANCE FROM INCREASING PHYSICAL ACTIVITY TO DECREASING PHYSICAL INACTIVITY]. Rotman, D., Constantini, N.[2018]

Sedentary behavior and physical inactivity are major risk factors for cardiovascular disease and overall mortality, highlighting the urgent need for increased physical activity across all demographics.

Improving cardiorespiratory fitness through exercise training is essential for preventing chronic diseases, particularly cardiovascular issues, and should be prioritized in healthcare strategies globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary Behavior, Exercise, and Cardiovascular Health. Lavie, CJ., Ozemek, C., Carbone, S., et al.[2019]

A review of 26 studies found that interventions aimed at reducing sedentary behavior in adults were categorized as very promising (39%), quite promising (21%), and non-promising (39%), with worksite-based interventions being the most common.

The most effective strategies included environmental restructuring and self-monitoring techniques, suggesting that future interventions should focus on modifying environments and enhancing self-regulatory skills to reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Gardner, B., Smith, L., Lorencatto, F., et al.[2023]

Sitting for long periods has harmful effects on cardiovascular and metabolic health, even for those who meet physical activity guidelines, highlighting the need to address sedentary behavior as a serious health risk.

Emerging evidence suggests that the physiological effects of inactivity are distinct from those of regular exercise, indicating that reducing sitting time and increasing breaks from sitting should be considered in health recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. Hamilton, MT., Healy, GN., Dunstan, DW., et al.[2022]

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