ACTIVE_NOT_RECRUITING

The Sedentary to Active Rising to Thrive (START) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-28
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06023680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged ≥65 years
  2. * Pre-frail defined as having 1-2 of the following criteria:
  3. * Self-reported unintentional weight loss
  4. * Self-reported fatigue
  5. * Self-reported low activity
  6. * Slowness measured during a 4-m walking test
  7. * Weakness measured with grip strength
  8. * Self-reported regular physical activity \<20 minutes/day
  9. * Self-reported willingness to work up to walking for 30 minutes/day
  10. * Self-reported ability to find a place to walk for up to 30 minutes/day
  11. * Agree to all study procedures and assessments
  12. * Ability to provide informed consent
  1. * Self-reported diabetes
  2. * Self-reported problems related to alcohol or drugs
  3. * Self-reported inability to walk across a room
  4. * Self-reported use of a walker
  5. * Self-reported requirement of medical supervision when engaging in physical activity
  6. * Fallen \>2 times in the past month
  7. * Participation in another clinical trial
  8. * Plan to move out of the area within 6 months
  9. * Inability to provide self-transportation to study assessment visits
  10. * Inability to complete a usual-paced 400m walking test within 15 minutes without sitting or the help of another
  11. * Uncontrolled resting hypertension (\>160/90 mmHg)
  12. * Cognitive impairment determined using the Montreal Cognitive Assessment Test

Contacts and Locations

Principal Investigator

Amal Wanigatunga, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Blomberg School of Public Health

Study Locations (Sites)

Johns Hopkins ProHealth
Baltimore, Maryland, 21207
United States
Bayview Medical Center
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Amal Wanigatunga, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Blomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Physical Activity
  • Walking
  • Older Adults

Additional Relevant MeSH Terms

  • Sedentary Time
  • Frailty