Physical Activity for Sedentary Lifestyle

Overseen By Kathryn Schmitz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Heart failure, Hypertension, Pregnancy, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to encourage physical activity among people in rural Pennsylvania who are not very active. The study includes two groups: one group will receive coaching calls and track their physical activity, while the other will only track activity to observe lifestyle changes over time. It suits those living in rural Pennsylvania who are less active than desired and have a BMI over 25 or diabetes. As an unphased trial, this study allows participants to contribute to innovative strategies that could enhance physical activity in rural communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity, so it's best to ask the trial organizers for more details.

What prior data suggests that this physical activity intervention is safe?

Research shows that being active is generally safe and manageable. The World Health Organization states that the benefits of physical activity outweigh the potential risks. Studies indicate that active individuals have a lower risk of mortality compared to inactive ones. Although every activity carries some risk, the likelihood of injury from regular physical activity is low. Therefore, considering participation in a trial to increase activity appears to be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on the power of physical activity as a treatment for a sedentary lifestyle, which is a fresh approach compared to traditional options like medication or nutritional counseling. Unlike these standard methods, this trial uses personalized coaching calls combined with objective tracking through accelerometers to motivate and monitor participants' progress over time. This innovative method not only promotes sustained physical activity but also provides concrete data on its impact, potentially leading to more effective lifestyle interventions.

What evidence suggests that physical activity is effective for addressing sedentary lifestyles?

This trial will compare a Physical Activity intervention with a Delayed intervention. Studies have shown that regular physical activity provides many health benefits. For instance, it can lower the risk of early death by 20% to 30% compared to inactivity. Research also indicates that increased activity can reduce the risk of dying from heart disease by 22% to 31%. Thus, moving more often benefits heart health and longevity. Physical activity also combats the negative effects of excessive sitting, which can alter body shape and reduce physical ability. Overall, these findings strongly support the idea that increased activity can enhance health and well-being. ^{1 2 5 6 7}

Who Is on the Research Team?

Kathryn Schmitz, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in rural Pennsylvania who are overweight, obese, or have Type 2 diabetes and do less than 90 minutes of exercise a week. They must be able to walk, speak English, understand the study details, and not be pregnant or have severe health issues that could interfere with their participation.

Inclusion Criteria

You live in a rural area in Pennsylvania with certain codes that identify it as rural.

You answered "no" to all the questions on the Physical Activity Readiness Questionnaire (PAR-Q).

Primary care patient of one of the participating providers

Exclusion Criteria

I do not have serious heart conditions or recent major heart or lung issues.

Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)

Your medical record shows that you have a condition that makes physical activity unsafe for you.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive five physical activity coaching calls with MoveLine and engage in weekly physical activity

24 months

5 coaching calls (telephone)

Follow-up

Participants are monitored for changes in physical activity levels using accelerometry and questionnaires

24 months

3 assessments (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• Delayed intervention
• Physical Activity

Trial Overview

The PA Moves Trial aims to increase physical activity among physically inactive rural residents. Participants will start a physical activity program at different times to compare how starting at various points affects their health outcomes.

How Is the Trial Designed?

Group I: Physical Activity intervention Active Control 1 Intervention

Five physical activity coaching calls with MoveLine and weekly physical activity. Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Group II: Delayed intervention Placebo Group 1 Intervention

Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

The study involves 239 Veterans with chronic obstructive pulmonary disease (COPD) participating in a randomized controlled trial to test the effectiveness of an Internet-mediated walking program called Taking Healthy Steps, which aims to increase physical activity and improve health outcomes.

Participants in the intervention group receive personalized feedback and support through a pedometer and online community, while the control group waits a year for their intervention, highlighting the potential for remote programs to engage older Veterans with significant health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. Martinez, CH., Moy, ML., Nguyen, HQ., et al.[2022]

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]

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]

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 is recognized as a significant risk factor for health issues, particularly in obese individuals, highlighting the need for targeted interventions to reduce sitting time.

Effective strategies to combat sedentary behavior include breaking up long periods of sitting with light activity and using new technologies to both measure and promote these changes in daily routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary behavior: target for change, challenge to assess. Rosenberger, M.[2021]

A physically active lifestyle significantly reduces the risk of chronic diseases, but sedentary individuals must be assessed for their risk of traumatic events before starting exercise programs.

Risk stratification helps tailor exercise prescriptions based on individual health status, ensuring safe and effective physical activity that can improve cardiovascular fitness, body composition, and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing and prescription. Practical recommendations for the sedentary. King, CN., Senn, MD.[2018]

Sedentary and unfit lifestyles significantly increase the risk of chronic diseases and functional limitations as people age, highlighting the importance of physical activity for overall health.

Even moderate amounts of physical activity can lead to improved health outcomes and reduced risks of morbidity and mortality, suggesting that encouraging the most sedentary 20-25% of the population to engage in at least moderate activity can provide substantial public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much physical activity should we do? The case for moderate amounts and intensities of physical activity. Blair, SN., Connelly, JC.[2007]

Citations

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Physical activity

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Massive study uncovers how much exercise is needed to ...

Meeting the minimum for moderate and vigorous activity can reduce cardiovascular disease mortality by 22% to 31%. A separate study published in JAMA Oncology ...

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pmc.ncbi.nlm.nih.gov

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bjsm.bmj.com

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World Health Organization 2020 guidelines on physical ...

The GDG concluded that the benefits of doing physical activity and limiting sedentary behaviour outweighed the potential harms. Any potential harms may be ...