United4Stroke (U4S) - El Paso Network Stroke Community Program

NCT06970210 | Enrolling By Invitation

• 1 other identifier: IRB#2153765
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

What is United4Stroke (U4S)? United4Stroke is a research program at the University of Texas at El Paso (UTEP) that aims to help stroke survivors become more active and reduce sedentary time through education, movement, and personalized coaching. Where Does It Happen? All sessions take place at: UTEP's Rehabilitation Sciences Complex located at 3333 North Mesa Street, El Paso, TX 79902 What is Involved? The program includes 12 total visits over several months:

• 8 group sessions (held every two weeks)
• 4 individual evaluation visits (before, during, and after the program) Who Can Participate?
• Individuals 18 years of age or older who have had a stroke at least 6 months prior to joining the study.
• Family caregivers may also join What Happens During the Visits? First Visit:
• Learn about the study and give consent
• Answer questions about memory, movement, general health, and daily activity
• Do walking and mobility tests
• Get fitted with a small movement sensor (ActivPAL) and a Fitbit Group Sessions (Visits 2-8):
• Topics: physical activity, sitting less, balance and falls, and activities of daily living
• Led by UTEP physical therapy faculty
• Includes group discussions and hands-on activities
• Some participants will also get one-on-one coaching to help with physical activity engagement, daily step count, and reducing sedentary behavior. Follow-Up Visits (Visits 9 and 11):
• Repeat earlier tests to check progress
• Share feedback about the program Final Visit (Visit 10):
• Celebrate progress!
• Social gathering, certificates, and a presentation of results Goal: To support stroke survivors in becoming more active and living healthier, more independent lives-step by step.

Conditions

Stroke

Keywords

Stroke; Quality of Life; Sedentary Behaviors; Sedentary Lifestyle; Physical Inactivity; Community Health Education

Outcome Measures

Primary Outcomes (1)

• Daily Step Count

  Daily step count data will be collected.

  Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).

Secondary Outcomes (7)

• Sedentary Behavior (Objective)

  Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).

• Sedentary Behavior (Subjective)

  Baseline, week 13 (post-intervention), and week 19 (follow-up).

• Quality of Life (QoL)

  Baseline, week 13 (post-intervention), and week 19 (follow-up).

• Quality of Life (QoL)

  Baseline, week 13 (post-intervention), and week 19 (follow-up).

• Mobility Performance

  Baseline, week 13 (post-intervention), and week 19 (follow-up).

Other Outcomes (3)

• Feasibility (adherence)

  Weeks 1-14 (intervention period)

• Feasibility (attendance frequency)

  Weeks 1-14 (intervention period)

• Feasibility (satisfaction)

  Week 13 (post-intervention)

Study Arms (2)

Group-Based Education Only

ACTIVE COMPARATOR

Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will not receive individualized coaching aimed at increasing daily step count, but will receive a Fitbit to be worn during the program.

Behavioral: Group-Based Education

Group-Based Education plus Individualized Coaching

EXPERIMENTAL

Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will receive individualized coaching aimed at increasing daily step count, reducing sedentary behavior, and engaging in physical activities. They will also receive a Fitbit to be worn during the program.

Behavioral: Group-Based Education; Behavioral: Individualized Coaching

Interventions

Group-Based Education BEHAVIORAL

The group-based education will consist of group sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. Social interactions amongst group members will be facilitated through group activities and discussions regarding the topics being discussed.

Group-Based Education Only; Group-Based Education plus Individualized Coaching

Individualized Coaching BEHAVIORAL

Individualized coaching aims to increase the participants daily step count. Participants will be encouraged to achieve step count increases of 2%, 5%, or 10% per week or visit, depending on their readiness and willingness to progress. SMART goal-setting strategies will be employed to assist with the goal setting. Participants may also receive coaching related to reducing sedentary behavior and engaging in physical activities.

Group-Based Education plus Individualized Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Texas, El Paso: lead

Study Sites (1)

The University of Texas at El Paso: Rehabilitation Sciences Complex

El Paso, Texas, 79902, United States

Location

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MeSH Terms

Conditions

Stroke; Sedentary Behavior; Health Education

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Camila Torriani-Pasin, PhD, PT

  The University of Texas at El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 14, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)