Exercise, Hypoxia and CPC in TBI Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hypoxia
Study type: Interventional

Summary: 
      Circulating progenitor cells (CPC) treatments may have great potential for the recovery of
      neurons and brain function. Our group has reported how exposure to intermittent hypobaric
      hypoxia with superficial muscle electrostimulation is able to increase the concentration of
      CPC in peripheral blood in humans. Therefore, we believe that through physical activities and
      exposure to intermittent hypobaric hypoxia for a period, it will increase CPC in the blood of
      subjects who have suffered a severe Traumatic Brain Injury (TBI) one or more years ago,
      promoting regeneration and functional and cognitive recovery. The study primary end-point is
      to improve physical or psychological functioning of participants with TBI with a program of
      exercise, muscle electro-stimulation (ME) and/or intermittent-hypobaric-hypoxia (IHH).
      Secondary end-points are to increase and maintain CPC and also to study their possible
      relationship with physical or psychological improvement of participants with Traumatic Brain
      Injury (TBI). In order to achieve these objectives investigators have designed a randomized
      controlled trial that will include those patients who suffered severe TBI more than one year
      previously with physical or psychological sequelae. Exercise, muscle electro-stimulation (ME)
      and/or intermittent hypobaric hypoxia (IHH) programs will be applied during twelve weeks.
      Psychological and physical stress tests will carry out before and after the program and CPC
      will measure at the beginning, every two weeks, and at the end of the program.
    

Detailed description: 
      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.
    

Intervention name(s): cognitive activities; Exercise program; Muscle electro-stimulation; Intermittent hypobaric hypoxia
Intervention type(s): Other; Other; Device; Other
Intervention description(s): Participants followed a day of cognitive activities 1 day (1 hour/day) per week during 12 weeks.; 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.; A program of intermittent hypobaric hypoxia and muscle electro-stimulation of 3 days (3 hours/day) per week during 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Traumatic brain injury; Exercise; Psychology; Physiology; Progenitor cells; Hypoxia