Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 21 - 45 |
| Updated: | 4/6/2019 |
| Start Date: | May 26, 2011 |
| End Date: | February 11, 2014 |
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....
- 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....
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.
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.
- INCLUSION CRITERIA:
Subjects eligible for participation in this research study must meet the following
inclusion criteria:
1. Diagnosis of non-penetrating mild, moderate, or severe TBI
2. Injury occurred at least 6 months prior to enrollment
3. Age 21-45 years
4. Physically inactive as identified by a physician.
5. Able to stand and walk on a treadmill independently and safely without assistance
6. Able to follow the study protocol
7. Fluent in English and able to provide informed consent
8. Willing and safely able to forego starting or changing an exercise program or
treatments that would potentially alter cardiorespiratory capacity or ability to
exercise and/or treatment for mood disorders
EXCLUSION 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:
1. Diagnosis or history of ischemic heart disease, including those with CABG and PTCA
2. Dilated or hypertrophic cardiomyopathy
3. Non-idiopathic cardiomyopathy
4. Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
5. Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
6. Diagnosis or history of restrictive or obstructive lung disease
7. Diagnosis or history of stroke
8. Type I or Type II Diabetes Mellitus
9. Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or
acute liver failure
10. Metastatic cancer active within the previous five years
11. Mitochondrial disease
12. On medications that would influence aerobic capacity, the ability to adapt to exercise
training, or treadmill performance such as beta blockers or antiretroviral therapy
13. Active substance abuse including ETOH
14. Ongoing tobacco use (any use within the past six months)
15. Medical or Psychological instability such that the subject could not reasonably be
expected to fulfill the study requirements
16. Pregnancy
17. BMI greater than 40 kg/m(2)
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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