CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
cognitive activities +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02083445
NCT02083445N/ACompleted

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

University of Barcelona·interventional·Posted Mar 11, 2014·Updated Mar 11, 2014

In Brief

A clinical study evaluating cognitive activities, Exercise program, and 2 other interventions for Traumatic Brain Injury. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2014
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.3 years ago

Interventions

cognitive activitiesother

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

Exercise programother

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.

Muscle electro-stimulationdevice

A program of intermittent hypobaric hypoxia and muscle electro-stimulation of 3 days (3 hours/day) per week during 12 weeks

Intermittent hypobaric hypoxiaother