A program to help older adults become more active and less sedentary

The Sedentary to Active Rising to Thrive (START) Trial: A Proof-of-Concept Sedentary Behavior Reduction Program

This study is testing two different ways to help older adults move more and sit less to see which method works better for improving their health and well-being.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Johns Hopkins Bloomberg School of Public Health (other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT06023680 on ClinicalTrials.gov

What this trial studies

This behavioral clinical trial aims to compare two different methods for reducing sedentary behavior in older adults at risk of frailty. Participants will be randomized into one of two interventions designed to gradually replace 30 minutes of sedentary time with light walking over a 60-day period. The study will assess whether one continuous walking session or three shorter walking sessions are more effective, as well as the impact on participants' overall well-being, stress levels, and metabolic health. The interventions will utilize remote monitoring to track progress and outcomes in real-world settings.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 65 and above who are pre-frail and willing to engage in a walking program.

Not a fit: Patients who are unable to walk across a room or require medical supervision for physical activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the physical activity levels and overall health of older adults, reducing their risk of frailty.

How similar studies have performed: Other studies have shown success in using similar approaches to reduce sedentary behavior among older adults, making this intervention both relevant and promising.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Baltimore, Maryland and 1 other locations

• Johns Hopkins ProHealth — Baltimore, Maryland, United States (RECRUITING)
• Bayview Medical Center — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Amal Wanigatunga, PhD — Johns Hopkins Blomberg School of Public Health
• Study coordinator: Amal Wanigatunga, PhD, MPH

Conditions: Sedentary Time, Frailty, Physical Activity, Walking, Older Adults