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Prescribed vs Self-Paced Exercise for Sedentary Lifestyle (WTW Trial)

Phase 2

Recruiting

Led By David M Williams, Ph.D.

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 50-64

Be between 18 and 65 years old

Must not have

- Exercise-induced asthma that prevents brisk walking

- Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, and months 3, 6, 9, and 12.

Awards & highlights

Summary

This trial will examine whether a self-selected or prescribed moderate intensity physical activity intervention leads to better outcomes in adults aged 50-64.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from participating in this physical activity program may include general discomforts like muscle soreness or fatigue due to increased activity levels. However specific side effects are not detailed as it largely depends on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma stops me from walking fast.

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I have had leg pain while walking fast due to a blood vessel condition in the past 6 months.

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I was hospitalized overnight for a lung problem in the last 6 months.

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I have experienced dizziness or fainting in the last 6 months.

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I have had a seizure in the last 6 months.

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I have not been hospitalized overnight in the past 3 months.

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I have been unable to walk without help for the past 3 months due to a stroke, TIA, or a nerve/spine injury.

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I have been diagnosed with cystic fibrosis.

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I cannot walk for 30 minutes due to bone or joint issues.

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I can walk by myself for 30 minutes without stopping.

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I have experienced chest pain or discomfort in the past 6 months.

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I have had heart treatment, like surgery or a stent, in the last 3 months.

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I take insulin or medication that influences insulin production.

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I take medication for seizures.

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I have not been hospitalized overnight for psychiatric reasons in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, and months 3, 6, 9, and 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, and months 3, 6, 9, and 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, and months 3, 6, 9, and 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in total volume of structured PA

Minutes per week of PA

Secondary outcome measures

Changes in Body Weight

Other outcome measures

12 Item Short Form (SF-12) Health Survey

Activity Tracker Use Questionnaire

Attitude towards Physical Activity - Affective Attitude Questionnaire

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Paced Intensity Physical ActivityExperimental Treatment1 Intervention

Group II: Prescribed Moderate Intensity Physical ActivityActive Control1 Intervention

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

459 Previous Clinical Trials

559,117 Total Patients Enrolled

1 Trials studying Sedentary Lifestyle

232 Patients Enrolled for Sedentary Lifestyle

National Institute on Aging (NIA)NIH

1,704 Previous Clinical Trials

28,033,017 Total Patients Enrolled

19 Trials studying Sedentary Lifestyle

4,202 Patients Enrolled for Sedentary Lifestyle

David M Williams, Ph.D.Principal InvestigatorBrown University School of Public Health

2 Previous Clinical Trials

389 Total Patients Enrolled

Media Library

Prescribed Moderate Intensity Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT05285748 — Phase 2

Sedentary Lifestyle Research Study Groups: Prescribed Moderate Intensity Physical Activity, Self-Paced Intensity Physical Activity

Sedentary Lifestyle Clinical Trial 2023: Prescribed Moderate Intensity Physical Activity Highlights & Side Effects. Trial Name: NCT05285748 — Phase 2

Prescribed Moderate Intensity Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285748 — Phase 2

~103 spots leftby May 2026

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