The Sedentary to Active Rising to Thrive (START) Trial (NCT06023680) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Sedentary to Active Rising to Thrive (START) Trial
United States61 participantsStarted 2023-11-28
Plain-language 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 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sedentary Time
Timeframe: Baseline, 2 months
2
Intervention Difference in the Change in Sedentary Time
Timeframe: Baseline, 2 months
Trial details
NCT IDNCT06023680
SponsorJohns Hopkins Bloomberg School of Public Health