Treatment Optimization of Brain-injured Warfighters: A Prescribed Sub-symptomatic Exercise Treatment

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Intrepid Spirit Center
RECRUITING
Camp Pendleton
Contact Information
Primary
Jason M Bailie, PhD
jason.m.bailie.ctr@health.mil
(760) 719-4202
Backup
Juan J Lopez, BA
juan.j.lopez120.ctr@health.mil
(760) 719-4229
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2026-09
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: United States Naval Medical Center, San Diego

This content was sourced from clinicaltrials.gov