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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight \[25 \< BMI \< 30\]) or obese (30 \< BMI \<40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

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.

What data supports the effectiveness of the treatment Prescribed Moderate Intensity Physical Activity, Moderate Intensity Exercise, Regular Physical Activity, Self-Paced Intensity Physical Activity, Self-Selected Intensity Physical Activity, Moderate Intensity Physical Activity for sedentary lifestyle?

Research shows that moderate intensity exercise leads to better adherence and more exercise completion compared to higher intensity exercise. Additionally, self-directed exercise programs improve health outcomes like cardiorespiratory fitness and metabolic health in sedentary individuals. ^{1 2 3 4 5}

Is exercise, whether prescribed or self-paced, generally safe for sedentary individuals?

Exercise, whether prescribed or self-paced, is generally safe for sedentary individuals. Studies show that moderate-intensity exercise is well-tolerated and can improve health outcomes without significant safety concerns. ^{1 3 6 7 8}

How does the treatment of prescribed vs self-paced exercise differ from other treatments for a sedentary lifestyle?

This treatment is unique because it compares prescribed moderate-intensity exercise with self-paced exercise, allowing individuals to choose their own intensity. This approach may improve adherence and enjoyment, making it more effective for maintaining regular physical activity compared to more rigid exercise prescriptions. ^{1 3 6 7 9}

Research Team

David M Williams, Ph.D.

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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 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]

References

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

Adherence to exercise prescriptions: effects of prescribing moderate versus higher levels of intensity and frequency. [2022]

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

A randomized trial of physical activity interventions: design and baseline data from project active. [2019]

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

Self-directed exercise programmes in sedentary middle-aged individuals in good overall health; a systematic review. [2019]

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

Exercise testing and prescription. Practical recommendations for the sedentary. [2018]

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

Can self-reported preference for exercise intensity predict physiologically defined self-selected exercise intensity? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Self-Selected Exercise Workloads on Perceived Enjoyment and Self-Efficacy in Sedentary Adults. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

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

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