Status:
ACTIVE_NOT_RECRUITING
The Sedentary to Active Rising to Thrive (START) Trial
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Sedentary Time
Frailty
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail. The main question this pr...
Detailed Description
Initiating and maintaining habitual physical activity is difficult for sedentary older adults, particularly those encumbered by health challenges. The 2018 US Physical Activity Guidelines recommends t...
Eligibility Criteria
Inclusion
- Adults aged ≥65 years
- Pre-frail defined as having 1-2 of the following criteria:
- Self-reported unintentional weight loss
- Self-reported fatigue
- Self-reported low activity
- Slowness measured during a 4-m walking test
- Weakness measured with grip strength
- Self-reported regular physical activity \<20 minutes/day
- Self-reported willingness to work up to walking for 30 minutes/day
- Self-reported ability to find a place to walk for up to 30 minutes/day
- Agree to all study procedures and assessments
- Ability to provide informed consent
Exclusion
- Self-reported diabetes
- Self-reported problems related to alcohol or drugs
- Self-reported inability to walk across a room
- Self-reported use of a walker
- Self-reported requirement of medical supervision when engaging in physical activity
- Fallen \>2 times in the past month
- Participation in another clinical trial
- Plan to move out of the area within 6 months
- Inability to provide self-transportation to study assessment visits
- Inability to complete a usual-paced 400m walking test within 15 minutes without sitting or the help of another
- Uncontrolled resting hypertension (\>160/90 mmHg)
- Cognitive impairment determined using the Montreal Cognitive Assessment Test
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06023680
Start Date
November 28 2023
End Date
June 1 2027
Last Update
September 9 2025
Active Locations (2)
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1
Johns Hopkins ProHealth
Baltimore, Maryland, United States, 21207
2
Bayview Medical Center
Baltimore, Maryland, United States, 21224