Prescribed vs Self-Paced Exercise for Sedentary Lifestyle

(WTW Trial)

Overseen By Lauren C Bohlen, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Brown University

Must not be taking: Insulin, Anticonvulsants, Beta blockers, others

Disqualifiers: Heart disease, Seizures, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different exercise approaches can help people with a sedentary lifestyle become more active. Participants will either follow a set exercise plan (Prescribed Moderate Intensity Physical Activity) or choose their own pace (Self-Paced Intensity Physical Activity) to determine which method more effectively improves physical activity. The trial seeks adults aged 50-64 with a BMI between 25 and 40 who currently engage in less than 60 minutes of structured exercise per week. Participants need a smartphone with regular internet access.

As a Phase 2 trial, this research focuses on measuring the effectiveness of the exercise methods in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications to join the trial?

Yes, if you are currently taking medications that affect heart rate, such as beta blockers, calcium channel blockers, or digoxin, you will not be eligible to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both planned moderate exercise and self-paced exercise are safe and well-tolerated for most people. Studies suggest that adults should aim for 150 to 300 minutes of moderate exercise each week to improve health and lower the risk of major diseases.

For planned exercise, guidelines from the World Health Organization and the American Heart Association recommend this amount of moderate activity, indicating it is generally safe for adults. No major negative effects have been reported at these levels of activity.

Research also supports exercise at one's own pace, where individuals choose their workout intensity. This approach can boost fitness and health, especially for those who are not very active initially. Experts recommend starting with lighter activities and gradually increasing intensity to avoid discomfort or strain.

Overall, both methods are well-supported by evidence and considered safe for most people, offering clear health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of different exercise approaches for people with sedentary lifestyles. Unlike traditional exercise programs that often prescribe a fixed routine, this trial compares prescribed moderate-intensity exercise with self-paced exercise, where participants control their own intensity. This approach could empower individuals to engage in physical activity that better suits their personal preferences and capabilities, potentially leading to higher adherence and better long-term results. The trial aims to find out if giving people more control over their exercise intensity can improve their lifestyle and health more effectively than a one-size-fits-all prescription.

What evidence suggests that this trial's treatments could be effective for a sedentary lifestyle?

Research shows that regular moderate exercise, like the kind studied in this trial, benefits health. Participants may be assigned to the Prescribed Moderate Intensity Physical Activity arm, which involves at least 150 minutes of moderate exercise each week. This regimen is known to lower the risk of death, improve heart health, reduce blood pressure, and enhance mental well-being.

Alternatively, participants may join the Self-Paced Intensity Physical Activity arm, allowing individuals to choose their workout intensity. This approach might make exercise more enjoyable and easier to maintain. Some research suggests that self-paced exercise can help those who usually don't exercise to be more consistent. By setting their own pace, participants might feel more motivated to continue their exercise routine.

Both methods in this trial aim to reduce inactivity and improve overall health. Prescribed exercise follows specific guidelines, while self-paced exercise offers more flexibility. ^{1 2 4 6 7}

Who Is on the Research Team?

David M Williams, Ph.D.

Principal Investigator

Brown University School of Public Health

Are You a Good Fit for This Trial?

This trial is for sedentary or low-active adults aged 50-64 with a BMI of 25-40. They must have a smartphone compatible with the study app and be able to walk without assistance. Exclusions include recent hospitalizations, heart disease treatments, major surgeries, certain medical conditions that limit exercise ability, psychiatric hospitalization, non-Rhode Island residents or those not fluent in English.

Inclusion Criteria

BMI 25-40

Sedentary or low-active, defined as participating in less than 60 min/week of structured exercise

I am between 50 and 64 years old.

Exclusion Criteria

- Household member is participating in this study

- Currently pregnant or planning to become pregnant in the next year

My asthma stops me from walking fast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (telephone)

Baseline Assessment

Orientation session, informed consent, baseline assessment including bodyweight, fitness test, dietary intake, and questionnaires

1 week

1 visit (in-person)

Randomization and Intervention

Participants are randomized to self-paced or prescribed intensity conditions and receive PA promotion intervention

52 weeks

Ongoing monitoring with accelerometers and heart rate monitors

Follow-up

Participants are monitored for changes in physical activity and body weight at 3-month intervals

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Prescribed Moderate Intensity Physical Activity
• Self-Paced Intensity Physical Activity

Trial Overview The study compares two physical activity programs: one where participants choose their own pace (SELF-PACED) and another with a prescribed moderate intensity (PRESCRIBED). Participants will wear accelerometers and use heart rate monitors to track activity levels over a year, with follow-ups at months 3, 6, 9, and 12.

How Is the Trial Designed?

Group I: Self-Paced Intensity Physical Activity Experimental Treatment 1 Intervention

Group II: Prescribed Moderate Intensity Physical Activity Active Control 1 Intervention

Prescribed Moderate Intensity Physical Activity is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Physical Activity Guidelines for:

• General Health and Fitness
• Cardiovascular Health
• Weight Management

Approved in European Union as Physical Activity Recommendations for:

• General Health and Fitness
• Cardiovascular Health
• Weight Management

Approved in Canada as Physical Activity Guidelines for Adults for:

• General Health and Fitness
• Cardiovascular Health
• Weight Management

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Self-directed exercise programs are effective in improving health-related outcomes, such as metabolic health, physical characteristics, cardiorespiratory fitness, and functional measures in sedentary middle-aged adults.

The review analyzed 21 randomized controlled trials, highlighting the importance of tailored exercise prescriptions that promote adherence and can be performed independently to support healthy aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed exercise programmes in sedentary middle-aged individuals in good overall health; a systematic review. Byrne, H., Caulfield, B., De Vito, G.[2019]

The Women's Health Study (WHS) is collecting accelerometer data on physical activity and sedentary behavior from approximately 18,000 women aged 62 and older to better understand the health effects of light-intensity activities and sedentary behavior.

As of August 2013, over 11,590 women have contributed data, highlighting the feasibility of using movement sensors in large-scale studies to provide objective measures that could clarify the relationship between physical activity levels and chronic disease risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using accelerometers to measure physical activity in large-scale epidemiological studies: issues and challenges. Lee, IM., Shiroma, EJ.[2022]

In a study of 59 overweight adults, those who were recommended to engage in self-paced exercise walked significantly more each week compared to those who were advised to exercise at a moderate intensity.

The self-paced group averaged about 26 additional minutes of walking per week, suggesting that allowing individuals to choose their own pace can enhance adherence to exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Williams, DM., Dunsiger, S., Miranda, R., et al.[2023]

The study involved 23 previously sedentary middle-aged women and found that their preferences for exercise intensity significantly predicted the intensity they chose during a treadmill session.

After accounting for factors like age and body mass index, the preference scale was shown to explain a notable amount of variance in the oxygen uptake during self-selected exercise, highlighting the importance of individual preferences in exercise prescription.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can self-reported preference for exercise intensity predict physiologically defined self-selected exercise intensity? Ekkekakis, P., Lind, E., Joens-Matre, RR.[2022]

In a study of 379 sedentary adults, those assigned to walk 30 minutes per day at a higher frequency (5-7 days per week) completed significantly more exercise compared to those walking 3-4 days per week.

Participants who exercised at a moderate intensity (45%-55% of maximum heart rate reserve) showed better adherence to the exercise regimen, while higher intensity (65%-75%) led to lower adherence and less overall exercise completed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to exercise prescriptions: effects of prescribing moderate versus higher levels of intensity and frequency. Perri, MG., Anton, SD., Durning, PE., et al.[2022]

In a study involving 16 sedentary adults, participants found both self-selected interval and continuous treadmill exercises equally enjoyable, indicating that the type of exercise may not impact enjoyment when individuals choose their own intensity.

There were no significant differences in self-efficacy or perceived enjoyment between the two exercise types, suggesting that sedentary individuals can effectively self-select moderate-intensity workloads regardless of the exercise format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Self-Selected Exercise Workloads on Perceived Enjoyment and Self-Efficacy in Sedentary Adults. Waaso, P., Gofton, N., Zuhl, M.[2022]

Project Active is a 2-year randomized trial involving 235 initially sedentary adults, comparing a personalized Lifestyle physical activity intervention to a traditional Structured exercise prescription.

The study aims to determine if the Lifestyle approach, which tailors physical activity to individual preferences, leads to greater improvements in energy expenditure and cardiorespiratory fitness compared to the Structured method over 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of physical activity interventions: design and baseline data from project active. Kohl, HW., Dunn, AL., Marcus, BH., et al.[2019]

In a 12-week study involving 44 previously sedentary adults, participants who self-selected their cardiovascular exercise routines showed significant improvements in cardiorespiratory fitness (VO2 max) and reductions in depression and tension scores.

The study found that while exercise led to positive mood changes and fitness improvements, there was no correlation between changes in mood and cardiorespiratory fitness, suggesting that the benefits of exercise on mental health may occur independently of physical fitness gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in relations of cardiorespiratory and mood changes associated with self-selected amounts of cardiovascular exercise. Annesi, JJ.[2015]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7719906/

World Health Organization 2020 guidelines on physical ... Many of the benefits of physical activity are observed within average weekly volumes of 150–300 min of moderate intensity or 75–150 min of vigorous intensity, ...

2. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active. Regular physical ...

3. acsm.org acsm.org/education-resources/trending-topics-resources/physical-activity-guidelines/

Physical Activity Guidelines ACSM provides recommendations and guidelines for physical activity and exercise based on the latest science and insights from health professionals.

4. health.gov health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf

Physical Activity Guidelines for Americans, 2nd edition For substantial health benefits, adults should do at least 150 minutes (2 hours and 30 minutes) to 300 minutes (5 hours) a week of moderate-intensity, or 75 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6536904/

An Overview of Current Physical Activity ... Current recommendations for physical activity in adults are as follows: at least 150–300 minutes per week of moderate-intensity, 75–150 minutes per week of ...

6. heart.org heart.org/en/healthy-living/fitness/fitness-basics/aha-recs-for-physical-activity-in-adults

AHA Physical Activity Recommendations ... Get at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK566046/

RECOMMENDATIONS - WHO Guidelines on Physical Activity ... Adults should do at least 150–300 minutes of moderate-intensity aerobic physical activity; or at least 75–150 minutes of vigorous-intensity aerobic physical ...