The Sedentary to Active Rising to Thrive (START) Trial

NCT06023680 | Active Not Recruiting

• 2 other identifiers: IRB00023391K01AG076967
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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 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. 1.whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts
2. 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. 3.whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism

Conditions

Sedentary Time; Frailty

Keywords

Physical Activity; Walking; Older Adults

Outcome Measures

Primary Outcomes (2)

• Change in Sedentary Time

  Sedentary time measured with a wrist worn monitor containing an accelerometer sensor This measurement is collected under a 7-day/24-hour wear protocol at baseline and again 2 months afterwards to determine the change in sedentary time before and after either intervention.

  Baseline, 2 months

• Intervention Difference in the Change in Sedentary Time

  Comparing the 2-month change in sedentary time between the two interventions

  Baseline, 2 months

Secondary Outcomes (23)

• Change in Physical Activity Accumulation

  Baseline, 2 months

• Change in Walking Ability

  Baseline, 2 months

• Change in Walking Speed

  Baseline, 2 months

• Change in Fatigue

  Baseline, 2 months

• Change in Fatigability

  Baseline, 2 months

Study Arms (2)

Continuous sedentary reduction intervention

ACTIVE COMPARATOR

Structured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout

Behavioral: Continuous sedentary reduction intervention

Bouted sedentary reduction intervention

ACTIVE COMPARATOR

Structured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts

Behavioral: Bouted sedentary reduction intervention

Interventions

Continuous sedentary reduction intervention BEHAVIORAL

During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days.

Continuous sedentary reduction intervention

Bouted sedentary reduction intervention BEHAVIORAL

During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days.

Bouted sedentary reduction intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Location

Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amal Wanigatunga, PhD

  Johns Hopkins Blomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: November 28, 2023
• Primary Completion: November 4, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)