The Sedentary to Active Rising to Thrive (START) Trial

Running, not enrolling · Not applicable

Conditions studied: Sedentary Time, Frailty

In brief

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 project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days. There are other questions this project aims to answer that include: 1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts 2. whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active 3. whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.

Key facts

Study ID

NCT06023680

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

61

Starts

2023-11-28

Expected to finish

2027-06-01

Last updated by the study team

2026-01-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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