Exercise, Hypoxia and CPC in TBI Patients (TCECAM)

March 7, 2014 updated by: Luisa Corral, University of Barcelona

Exercise, Muscle Electro-stimulation and Intermittent Hypobaric Hypoxia Program and Circulating Progenitor Cells in Traumatic Brain Injured Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • University of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients who suffered severe TBI more than one year previously with physical or psychological sequelae.
  • Written informed consent from patient

Exclusion Criteria:

  • Epilepsy
  • Any medical or psychological contraindications for implementing the program of physical activity or hypobaric chamber.
  • Inclusion in other ongoing study
  • Refuse consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week before and an expected average of one week after the intervention
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)
One week before and an average of one week after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The day before, every 15 days during the intervention and two weeks after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
An average of two weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

Ministerio de Economía y Competitividad, Spain

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 1, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP2010-222005-C02-02
  • AC048-10, PR017/10 (Other Identifier: Comité de Ética de Investigación Clínica de Bellvitge)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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