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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, and months 3, 6, 9, and 12.
Awards & highlights
WTW Trial 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.
WTW Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 64 years old.
WTW Trial 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.
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 moreWTW 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
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Who is running the clinical trial?
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,114 Total Patients Enrolled
1 Trials studying Sedentary Lifestyle
232 Patients Enrolled for Sedentary Lifestyle
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,823 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My asthma stops me from walking fast.I have had leg pain while walking fast due to a blood vessel condition in the past 6 months.I am between 50 and 64 years old.I was hospitalized overnight for a lung problem in the last 6 months.I have experienced dizziness or fainting in the last 6 months.I have had a seizure in the last 6 months.I have not been hospitalized overnight in the past 3 months.I haven't had major surgeries in the last year and don't plan any soon.I have been unable to walk without help for the past 3 months due to a stroke, TIA, or a nerve/spine injury.I have been diagnosed with cystic fibrosis.I cannot walk for 30 minutes due to bone or joint issues.My doctor says I need a hip or knee replacement soon.I can walk by myself for 30 minutes without stopping.I have experienced chest pain or discomfort in the past 6 months.I have had heart treatment, like surgery or a stent, in the last 3 months.I take insulin or medication that influences insulin production.I take medication for seizures.I have not been hospitalized overnight for psychiatric reasons in the past year.I am taking or will take heart rate affecting meds like beta blockers.You don't engage in regular physical activity and exercise less than one hour per week.
Research Study Groups:
This trial has the following groups:- Group 1: Prescribed Moderate Intensity Physical Activity
- Group 2: Self-Paced Intensity Physical Activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project require that participants be over the age of 65?
"This specific clinical trial is only for patients aged 50 to 64. However, there are 9 other trials for patients under 18 and 48 trials for patients over 65 years old."
Answered by AI
How many volunteers are needed for this clinical research project?
"That is correct. The listing on clinicaltrials.gov says that the trial is currently looking for subjects. This experiment was originally posted on March 15th, 2022 and updated July 18th, 2022. They are seeking a total of 240 individuals from 1 location."
Answered by AI
Which type of patient does this research require?
"To be eligible for this trial, patients must meet the following requirements: they must fall between the ages of 50-64, have a BMI of 25-40, be considered sedentary or low active (defined as participating in less than 60 minutes per week of structured exercise), own a smartphone that can connect to the internet at least once every few days, and have a phone that is compatible with the smartphone app."
Answered by AI
Has the FDA looked into self-paced intensity physical activity as a form of exercise?
"Self-Paced Intensity Physical Activity has only been studied in Phase 2 trials, so there is some data indicating it is safe but no efficacy data. Our team at Power estimates the safety to be a 2."
Answered by AI
Are participants still being sought for this experiment?
"Yes, as indicated by the clinicaltrials.gov listing, this trial is still recruiting participants. The study was originally posted on March 15th, 2022 and updated on July 18th, 2022. They are looking for a total of 240 patients at 1 medical site."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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