Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury
Condition: Exercise; Fatigue; Physical Fitness; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      - Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low
      physical fitness causes severe fatigue that reduces the ability to perform routine daily
      activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise,
      such as treadmill walking or running, improves physical fitness in most people and may also
      decrease fatigue and improve mood. However, more information is needed to determine if
      exercise improves these conditions in people who have TBI.

      Objectives:

      - To examine the effect of an aerobic treadmill walking exercise program on physical fitness,
      fatigue, and mood in people with TBI.

      Eligibility:

      - Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury
      at least 6 months before participating; able to understand oral and written English language,
      give informed consent and sign a consent form; are physically inactive (including activities
      related to both job and recreation); and are able to stand and walk on a treadmill safely
      without help.

      Design:

        -  This study requires 4 testing visits and 36 exercise visits over 14 weeks.

        -  The first and third testing visits will last about 4 hours and the second and final
           testing visits will take about 2 hours.

        -  Testing visits will consist of a medical history and physical examination, completion of
           questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall
           quality of life), tests of thinking and a treadmill exercise test.

        -  Participants will have treadmill exercise training 3 days per week for 12 weeks. Each
           session includes a check-in, warm-up, treadmill walking at the training heart rate, and
           cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the
           sessions will include questionnaires to fill out and will last about one-and-a-half
           hours.

        -  After completing the exercise training program, participants will have a final testing
           visit to complete the questionnaires (about fatigue, daily physical activity, sleep
           quality, mood, and overall quality of life), tests of thinking and a treadmill exercise
           test.
    

Detailed description: 
      Objective

      The broad objective of this exploratory project is to inform clinical studies and trials on
      the use of aerobic exercise training (AET) as an intervention for improving cardiorespiratory
      fitness in patients with traumatic brain injury (TBI). AET-induced adaptation of
      cardiorespiratory fitness and fatigue severity will be characterized, and time-course for
      changes in mood reactivity will be determined. We hypothesize that 1) AET will improve both
      cardiorespiratory fitness and fatigue severity 2) mood will at first worsen in response to
      AET but that mood reactivity will then decrease at some point during the intervention, and 3)
      AET will not impair overall cognitive performance, but that the specific cognitive
      performance areas of attention and concentration will improve with AET.

      Study Population

      Thirty-six adult subjects with a clinical diagnosis of non-penetrating TBI (mild, moderate,
      and severe) will be enrolled. Subjects will be recruited from NIH, affiliated
      hospitals/clinics, and in the community.

      Design

      This is a pilot study with a pre-experimental, test-intervention-retest design.
      Cardiorespiratory fitness, fatigue severity, cognitive performance, and changes in mood
      reactivity will be measured at baseline. The subjects will then participate in a 12-week
      treadmill exercise training intervention protocol known to improve cardiorespiratory fitness
      in the general population. Following the 12 weeks of AET, cardiorespiratory fitness, fatigue
      severity, and cognitive performance will be retested and compared to baseline. Changes in
      mood reactivity will be assessed monthly.

      Outcome Measures

      AET-induced change in cardiorespiratory fitness as measured by peak oxygen consumption (VO2)
      is the primary outcome measure and will be measured by pulmonary gas exchange analysis during
      treadmill exercise tolerance testing. A submaximal, continuous work rate test will also be
      used to measure the ability of the cardiorespiratory system to meet the energy demands of
      work over time (VO2 on-kinetics). The Fatigue Severity Scale (FSS) is the principal
      measurement tool for the fatigue outcome variable. FSS scores will be interpreted in relation
      to information from the Medical Outcomes Study 36-Item Short Form (MOS-36SF), Becks
      Depression Inventory (BDI), The Pittsburgh Sleep Quality Index (PSQI), International Physical
      Activity Questionnaire (IPAQ) and the Profile of Mood States Short Form (POMS-SF). Cognitive
      performance will be tested and interpreted compared to norms by the Finger Tapping Test
      (FTT), the Trail Making Test (TMT) and the Repeatable Battery for the Assessment of
      Neuropsychological Status (RBANS). Change in mood reactivity will be measured as the
      difference in the POMS-SF scores before and after 30 minutes of recovery. The outcome
      variable for time-course related change in mood reactivity is the week of onset for
      significant improvement in mood reactivity.
    

Intervention name(s): Aerobic Exercise Training
Intervention type(s): Other
Intervention description(s): supervised exercise on the treadmill at target heart rate range for 12 weeks, 3 times a week for 30 minutes.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognition; TBI; Mood; Aerobic Exercise Training; Cardiorespiratory Fitness