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

48 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Reduced Physical Activity for a sedentary lifestyle?

Research shows that interventions targeting sedentary behavior, such as reducing sitting time, can lead to health improvements. Promising strategies include environmental changes and self-monitoring, which have been effective in reducing sedentary behavior and improving health outcomes. ^{1 2 3 4 5}

Is reduced physical activity safe for humans?

Research suggests that spending too much time sitting or being inactive is linked to higher risks of cancer and early death, but not necessarily heart disease. It's important to balance sitting with some movement to reduce these risks. ^{2 6 7 8 9}

How does the treatment 'Reduced Physical Activity' differ from other treatments for a sedentary lifestyle?

The treatment 'Reduced Physical Activity' is unique because it focuses on decreasing the amount of time spent sitting or being inactive, rather than increasing exercise levels. This approach is based on emerging evidence that excessive sitting is a health risk on its own, and reducing sedentary time can improve health even if physical activity levels remain the same. ^{10 11 12 13 14}

What is the purpose of this trial?

The far-reaching negative health effects of the reduced physical activity (RPA) epidemic are often overlooked by the general population and health professionals. Short-term RPA induces cardiometabolic dysfunction, including impaired glucose control and vascular function, that may precede disease development. The impact of existing health status on RPA-induced cardiometabolic dysfunction and recovery of impaired glucose control following RPA is unexplored. Thus, the investigators' objectives are 1) to investigate the effect of existing health status (cardiorespiratory fitness and adiposity) on the recovery of impaired glucose control following a period of RPA and 2) to determine the role of vascular function as a mechanism of impaired glucose control. The investigators' final objective is to 3) expose undergraduate students to meritorious biomedical clinical research methods. The investigators have piloted the clinical research methods and analysis with undergraduate researcher associates and are well-prepared to complete this proposal. Preliminary data show that low cardiorespiratory fitness and/or high adiposity impair the recovery of glucose control following short-term RPA. Thus, the investigators aim to examine the interactive role of health status (cardiorespiratory fitness and adiposity) on the ability to recover impaired glucose control following short-term RPA. The investigators also seek to examine changes in vascular function as a mechanism of recovery of impaired glucose control following a return to normal PA. The investigators will recruit men and women with divergent health status (cardiorespiratory fitness and adiposity) to examine glucose control and vascular function during 7-d of normal PA, 7-d of RPA, and 7-d of resumption of normal RA. Continuous glucose monitoring and oral glucose tolerance tests will be performed to assess glucose control. Increases in vascular shear stress induced by passive leg movement and central arterial stiffness will be measured to assess vascular function.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prospectively Reallocating Sedentary Time: Associations with Cardiometabolic Health. [2021]

2. England pubmed.ncbi.nlm.nih.gov

What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sedentary Behavior, Exercise, and Cardiovascular Health. [2019]

4. England pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of interventions to reduce sedentary behavior among older adults. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Associations between multiple indicators of objectively-measured and self-reported sedentary behaviour and cardiometabolic risk in older adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Association of Accelerometer-Measured Sedentary Accumulation Patterns With Incident Cardiovascular Disease, Cancer, and All-Cause Mortality. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Sedentary behaviour and health]. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Associations of Objectively Measured Physical Activity and Sedentary Time with the Risk of Stroke, Myocardial Infarction or All-Cause Mortality in 70-Year-Old Men and Women: A Prospective Cohort Study. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Motivational counseling to reduce sitting time: a community-based randomized controlled trial in adults. [2018]

11. England pubmed.ncbi.nlm.nih.gov

"Keeping Moving": factors associated with sedentary behaviour among older people recruited to an exercise promotion trial in general practice. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. [2022]

13. Israel pubmed.ncbi.nlm.nih.gov

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

14. New Zealand pubmed.ncbi.nlm.nih.gov

The Effectiveness of Sedentary Behaviour Reduction Workplace Interventions on Cardiometabolic Risk Markers: A Systematic Review. [2022]