Exercise, Hypoxia and CPC in TBI Patients (TCECAM)
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|ClinicalTrials.gov Identifier: NCT02083445|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: cognitive activities Other: Exercise program Device: Muscle electro-stimulation Other: Intermittent hypobaric hypoxia||Not Applicable|
Clinical, experimental, case control and prospective study. Inclusion criteria are: patients who suffered severe TBI more than one year previously with physical or psychological sequelae, male sex, and age 20-60 years old. Patients with epilepsy are not included. The study was approved by the institution's Research Ethics Committee and informed consent was obtained from the patients.
A program of three days per week during twelve weeks will be applied to the active groups: one, exercise and muscle electrical stimulation, and the other, exercise, muscle electrical stimulation and IHH chamber exposure. Control group participants will follow a a day of cognitive activities one day per week during 12 weeks.
Psychological and physical stress tests are carried out before and after the program. Psychological tests evaluate features of language and work (verbal memory-RAVLT), Trail Making Test (TMT A and B), Stroop Test, working memory capacity and attention (WAIS III), information processing speed (WAIS III), orientation and verbal fluency (Barcelona test), executive functions (WAIS III and Tower of London tests) and estimated premorbid intelligence index (vocabulary, WAIS III). Reduced Paced Auditory Serial Addition Test (PASAT-G) evaluate work memory components. Physical graded maximum stress tests were performed on a cycle ergometer increasing progressively the workload, in order to evaluate physical capacity and adaptation to different intensities of effort. CPC (CD34+) are measured in peripheral blood according to a previously used method (Viscor et al., 2009), at the beginning, every two weeks, and at the end of the program (blood samples were always obtained before the exercise sessions).
Statistical analysis: data will express as mean, median, standard deviation and interquartile range as appropriate. The continuous variables will compare using the Mann-Whitney U test. Wilcoxon signed rank test and Friedman test are used for repeated measures. All tests will perform using Statistical Package for the Social Sciences (SPSS) v.13. Statistical significance was set at P<0.05.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exercise, Muscle Electro-stimulation and Intermittent Hypobaric Hypoxia Program and Circulating Progenitor Cells in Traumatic Brain Injured Patients|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||February 2014|
Placebo Comparator: Control group
Once a week there will be an attendance cognitive session (specific sessions designed to work on aspects related to body perception, movement, space) and the extraction of blood samples will be carried out to determine the progenitor cells on the same day of the active groups.
Other: cognitive activities
Participants followed a day of cognitive activities 1 day (1 hour/day) per week during 12 weeks.
Active Comparator: Exercise group
Patients with past history of TBI will perform exercise sessions two hours three days a week during 12 weeks. The sessions will consist of aerobic, strength, flexibility, proprioception and balance activities and muscle electro-stimulation sessions or cycling sessions.
Other: Exercise program
Exercise program of endurance, resistance and proprioception exercises, comprising three sessions per week and muscle electro-stimulation was applied using the Compex Vitality® vascular and capillarization program with electrodes fixed in quadriceps and abdominal muscles or cycling exercise.
Active Comparator: Muscle electro-stimulation and IHH
Patients with past history of TBI will perform a 12 weeks program: intermittent hypobaric hypoxia (IHH) 2 hours at a simulated altitude of 4500 meters 3 days/week. Muscle electro-stimulation for two periods of 20 minutes during the stay in the hypobaric chamber.
Device: Muscle electro-stimulation
A program of intermittent hypobaric hypoxia and muscle electro-stimulation of 3 days (3 hours/day) per week during 12 weeks
Other: Intermittent hypobaric hypoxia
- Change from initial physical stress test at one week post-intervention [ Time Frame: One week before and an expected average of one week after the intervention ]Physical graded maximum stress tests are performed on a cycle ergometer controlling the workload, in order to evaluate physical capacity and adaptation to different intensities of effort.While performance of these tests are conducted, cardiocirculatory (control of heart rate, blood pressure measurement, continuous ECG) and respiratory (breathing gases analysis) are monitored to observe the adaptation to the effort.
- Change from initial psychological test at one weeks after intervention [ Time Frame: One week before and an average of one week after the intervention ]Psychological tests evaluated features of language and work (verbal memory-RAVLT), Trail Making Test (TMT A and B), Stroop Test, working memory capacity and attention (WAIS III), information processing speed (WAIS III), orientation and verbal fluency (Barcelona test), executive functions (WAIS III and Tower of London tests) and estimated premorbid intelligence index (vocabulary, WAIS III). Reduced Paced Auditory Serial Addition Test (PASAT-G)
- Circulating progenitor cells increase [ Time Frame: The day before, every 15 days during the intervention and two weeks after the intervention ]Blood CD34 staining and flow cytometry assay in accordance with ISHAGE guidelines (Keeney et al., 1998). CD34 cells/µL.
- Relationship between circulating progenitor cells and physical or psychological tests improvement [ Time Frame: An average of two weeks after intervention ]If a statistically significant increase of circulating progenitor cells occurs and physical and/or psychological tests improvement, their relationship will be analyzed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083445
|University of Barcelona|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Principal Investigator:||Luisa Corral, MD, PhD||University of Barcelona and Bellvitge University Hospital|
|Study Director:||Casimiro F Javierre, MD, PhD||Universiy of Barcelona|
|Study Chair:||Ginés Viscor, PhD||University of Barcelona|
|Study Director:||Josep L Ventura, MD, PhD||Bellvitge University Hospital|