Early respiratory therapy and rehabilitation interventions in the role of the prognosis of patients with acute traumatic spinal cord injury

ISRCTN ISRCTN16066516
DOI https://doi.org/10.1186/ISRCTN16066516
Secondary identifying numbers CMRPG8D1391
Submission date
30/09/2017
Registration date
10/10/2017
Last edited
09/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The spinal cord is a soft bundle of nerves that extends from the base of the brain to the lower back, through which the brain sends movement commands and receives sensory information. Spinal cord injury (SCI) is a catastrophic event associated with disruptions to the movement, sensory, cardiovascular (heart), and respiratory (breathing) systems. The aim of this study is to assess the effects of SCI on breathing function and the muscle power of the limbs, and whether treatment reverses these changes during the 6-month follow-up period.

Who can participate?
Acute Spinal Cord Injury (SCI) patients aged 20-70

What does the study involve?
Patients participate in a 12-week exercise rehabilitation program at least three times per week for 20 to 30 minutes, and a 12-week respiratory (breathing) muscle training program. At the start of the study and after 2 weeks, 1 month, 3 months and 6 months, participants undergo measurements including: breathing function, muscle power, heart rate, blood pressure, blood tests and brain MRI scans.

What are the possible benefits and risks of participating?
The blood test may cause short-term discomfort, bleeding or swelling. The other tests are not invasive and do not involve any risks for the patient.

Where is the study run from?
Chang Gung Memorial Hospital - Kaohsiung Branch (Taiwan)

When is the study starting and how long is it expected to run for?
February 2015 to January 2018

Who is funding the study?
Chang Gung Memorial Hospital, Linkou (Taiwan)

Who is the main contact?
Dr Hung-Chen Wang
m82whc@gmail.com

Contact information

Dr Hung-Chen Wang
Scientific

Kaohsiung Chang Gung Memorial Hospital
123, Ta Pei Road, Niao Sung Dist
Kaohsiung
83305
Taiwan

Phone +886 (0)7 7317123 ext 8011
Email m82whc@gmail.com

Study information

Study designSingle-centre interventional longitudinal case-control study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEarly aggressive respiratory therapy and rehabilitation interventions in the role of the prognosis of patients with acute traumatic spinal cord injury and explore oxidative stress, inflammation, DNA damage, leukocyte apoptosis and endothelial dysfunction, and its association with cardiovagal function and cerebral autoregulation
Study objectivesHypothesis: Endothelial oxidative stress and inflammation are increased, endothelium repair capacity are reduced, leukocyte apoptosis are decreased, and decreased gain of baroreflex sensitivity and cerebral autoregulation in patients with acute SCI compared with healthy subjects, and treatment reverses these biomarkers alterations, and changes of baroreflex sensitivity and cerebral autoregulation during the 6-month follow-up period.

The study will also explore which signaling pathways involved in the apoptosis of EPCs. The successful translation of these approaches to the clinics offers the promise of not only predicting the outcome but also assessing the impact of these factors on therapeutic efficacy.
Ethics approval(s)Chang Gung Memorial Hospital (TAIWAN), 13/01/2015, ref: 103-5218B
Health condition(s) or problem(s) studiedAcute spinal cord injury
InterventionRehabilitation treatment: Patients participated in a 12-week exercise program. They performed mobility, strength, range of motion, aerobic resistance, and ambulation training. A minimum exercise frequency of 3 times per week and a minimum duration of 20 to 30 minutes, and an exercise intensity of 70% to 80% of heart rate reserve is necessary to produce training effects.

Respiration treatment: Patients participated in a 12-week respiratory muscle training (RMT) program, including maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) monitor.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureMeasured at baseline, 2 weeks, 1 month, 3 months and 6 months:
1. Mechanical ventilation free rate (no mechanical ventilator used) at discharge
2. Respiratory function:
2.1. Maximal inspiratory pressure (MIP) measured with a pressure manometer
2.2. Maximal expiratory pressure (MEP) measured with a pressure manometer
2.3. Rapid shallow breathing index (RSBI, respiratory rate/tidal volume) measured using Haloscale
3. Muscle power of limbs, measured using Japanese Orthopaedic Association (JOA) cervical spine myelopathy functional assessment score
Secondary outcome measuresMeasured at baseline, 2 weeks, 1 month, 3 months and 6 months:
1. Endothelial oxidative stress, measured using ELISA
2. DNA damage, measured using RT-PCR
3. Inflammation, measured using ELISA
4. Leukocyte apoptosis, measured using a flow cytometic assay
5. Circulating endothelial progenitor cells (EPCs), measured using a flow cytometric method
6. Baroreflex sensitivity, measured using Valsalva maneuver and sequence method
7. Cerebral autoregulation, measured using Arterial Spin Labeling (ASL) MRI
Overall study start date01/02/2015
Completion date31/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants90
Key inclusion criteria1. Acute Spinal Cord Injury (SCI) patients aged 20-70 years old
2. Patients will be enrolled in this study only if full informed written consent is obtained from the patient or their families and they qualify for the above-mentioned diagnostic criteria. The informed written consent will be approved by the Ethics Committee
Key exclusion criteria1. Severe multiple trauma with unstable hemodynamic status
2. Previous brain insults, such as stroke, traumatic intracranial hemorrhage, meningitis, or degenerative brain diseases that cause central nerve system abnormality
3. Infection or inflammation status before admission
4. Diffuse atherosclerotic changes on extracranial vessels; hematologic disorders that affect leukocyte, platelet count, or function
5. Taking antiplatelet or anticoagulation drugs
6. Major systemic disease, such as end-stage renal diseases, liver cirrhosis, and congestive heart failure
Date of first enrolment21/04/2015
Date of final enrolment31/01/2018

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung
83305
Taiwan

Sponsor information

Chang Gung Memorial Hospital
Hospital/treatment centre

123, Ta Pei Road, Niao Sung Dist.
Kaohsiung
83305
Taiwan

Phone +886 (0)7 7317123
Email m82whc@gmail.com
ROR logo "ROR" https://ror.org/02verss31

Funders

Funder type

Hospital/treatment centre

Chang Gung Memorial Hospital, Linkou
Private sector organisation / Other non-profit organizations
Alternative name(s)
Linkou Chang Gung Memorial Hospital
Location
Taiwan

Results and Publications

Intention to publish date31/01/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.