Exercise, Hypoxia and CPC in TBI Patients

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.

Conditions

• Traumatic Brain Injury

Interventions

OTHER

cognitive activities

Participants followed a day of cognitive activities 1 day (1 hour/day) per week during 12 weeks.

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.

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

Sponsors & Collaborators

• Ministerio de Economía y Competitividad, Spain

  collaborator OTHER_GOV

• University of Barcelona

  lead OTHER

Principal Investigators

• Luisa Corral, MD, PhD · University of Barcelona and Bellvitge University Hospital

• Casimiro F Javierre, MD, PhD · Universiy of Barcelona

• Ginés Viscor, PhD · University of Barcelona

• Josep L Ventura, MD, PhD · Bellvitge University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-12-31

Completion

2014-02-28

Countries

• Spain

Study Locations