Recruiting

Observational Study

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT06561100

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Sub-symptomatic Adaptable Exercise Treatment (SAET)

Stretching Control Group (SCG)

Study Details

Brief summary:

Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty.

The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.

Conditions

Mild Traumatic Brain Injury

Study ID

NCT06561100

Start date

Sep 27, 2023

Status verified date

Aug, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Active duty, male or female, ages 18 to 55
  • History of at least one mTBI sustained more than 1 month ago
  • Service members (SMs) with ongoing symptoms

Exclusion Criteria:

  • SMs who sustained a TBI of any severity within 1 month of enrollment
  • History of moderate, severe, or penetrating TBI
  • Current substance use disorder
  • History of a neurological disease (e.g., multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder)
  • An acute orthopedic injury that limits the capacity to complete study procedures

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-symptomatic Adaptable Exercise Treatment (SAET)

Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. Participants will complete a combination of aerobic and resistance training exercises prescribed and adapted to the participant's personal needs based on evaluations by the Physical Therapist and Exercise Physiologist. Exercise will be adjusted to maintain sub-symptomatic levels, meaning that if a participant's neurobehavioral symptoms increase with activity, the intensity and/or exercise will be modified. Furthermore, participants will be asked to fill out an Exercise Habits Questionnaire (EHQ) in order to capture the exercises they are currently doing.

active comparator: Stretching Control Group (SCG)

Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. The stretching exercises are designed not to increase heart rate or have excessive head motion consist of static stretching and yoga based movements.

Interventions

Sub-symptomatic Adaptable Exercise Treatment (SAET)

Each workout will be structured in a similar format. The first 5 minutes will be devoted to stretching and warm up exercises. Then the next 20 minute segment devoted to light to moderate aerobic exercise. The second 20 minutes of each exercise session will be composed of a series of 5 predetermined exercises that rotate every day. Each workout will have one or two alternatives that the patient can complete either for modification to accommodate a physical limitation or to optimize preference. Resistance training each day will include multi-joint functional movements along with stability work. The last five minutes of the session will include more mobility work, and/or cooling down.

Stretching Control Group (SCG)

Each workout will be 50-60 minutes long and participants are instructed to not do any other type of exercise that may elevate their heart rate. Modifications will be available for stretches that may be too advanced for the individual.

Primary outcome measure

  • Neurobehavioral Symptom Change [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Jason M Bailie, PhD

(760) 719-4202jason.m.bailie.ctr@health.mil

Juan J Lopez, BA

(760) 719-4229juan.j.lopez120.ctr@health.mil

Locations

Intrepid Spirit Center

Recruiting

Camp Pendleton, California, United States, 92055

Contacts

Jeffrey D Bullock, DPT

760-763-9384jeffrey.d.bullock5.mil@health.mil

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Keywords

  • Progressive Return to Activity
  • Warfighter Readiness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2024-08-19.