Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury
|First Received Date ICMJE||February 10, 2011|
|Last Updated Date||July 22, 2015|
|Start Date ICMJE||January 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in peak oxygen consumption [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE
||Change in peak oxygen consumption|
|Change History||Complete list of historical versions of study NCT01294332 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury|
|Official Title ICMJE||Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury|
- 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.
- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI.
- 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.
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.
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Other: Rehabilitation
Aerobic Exercise Training
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects eligible for participation in this research study must meet the following inclusion criteria:
Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as:
|Ages||21 Years to 45 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01294332|
|Other Study ID Numbers ICMJE||110088, 11-CC-0088|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Center for Neuroscience and Regenerative Medicine (CNRM)|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP