Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.

Humans Double-Blind Method Exercise Therapy Hypoxia Pain / etiology Recovery of Function Spinal Cord Injuries / physiopathology Walking / physiology Clinical Trials, Phase II as Topic Randomized Controlled Trials as Topic
Endurance Intermittent hypoxia Locomotion Low oxygen Plasticity Speed Spinal cord injury Spinal cord trauma Walking

Journal

BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555

Informations de publication

Date de publication:
08 Jul 2020
Historique:
received: 10 06 2020
accepted: 01 07 2020
entrez: 10 7 2020
pubmed: 10 7 2020
medline: 28 10 2020
Statut: epublish

Résumé

Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury. To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI. ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.

Sections du résumé

BACKGROUND BACKGROUND
Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury.
METHODS METHODS
To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O
DISCUSSION CONCLUSIONS
The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.

Identifiants

DOI: 10.1186/s12883-020-01851-9 PMID: 32641012 PMC: PMC7341658
pubmed: 32641012
doi: 10.1186/s12883-020-01851-9
pii: 10.1186/s12883-020-01851-9
pmc: PMC7341658
doi:

Banques de données

ClinicalTrials.gov
['NCT02632422']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

273

Subventions

Organisme : U.S. Department of Defense (US)
ID : W81XWH-15-2-0045

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Auteurs

Avantika Naidu (A)

Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.
Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Denise M Peters (DM)

Department of Rehabilitation & Movement Science, University of Vermont, Burlington, VT, USA.

Andrew Q Tan (AQ)

Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.
Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Stella Barth (S)

Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Andrea Crane (A)

Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Angela Link (A)

Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Swapna Balakrishnan (S)

Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Heather B Hayes (HB)

Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA.

Chloe Slocum (C)

Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.
Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Ross D Zafonte (RD)

Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.
Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.

Randy D Trumbower (RD)

Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA. randy.trumbower@mgh.harvard.edu.
Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA. randy.trumbower@mgh.harvard.edu.
Program in Neuroscience, Graduate School of Arts and Sciences, Harvard University, Cambridge, MA, USA. randy.trumbower@mgh.harvard.edu.
ORCID: 0000-0002-2282-9974

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Thérapeutique › Techniques de physiothérapie › Traitement par les exercices physiques › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Signes et symptômes respiratoires › Hypoxie › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Phénomènes physiologiques de l'appareil locomoteur et du système nerveux › Phénomènes physiologiques du système nerveux › Sensation › Douleur › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Phénomènes biologiques › Récupération fonctionnelle › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Plaies et blessures › Traumatismes de la moelle épinière › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Activités humaines › Activités de loisirs › Loisir › Sports › Marche à pied › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques de phase II comme sujet › Daily acute intermittent hypoxia to improve...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Daily acute intermittent hypoxia to improve...