Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hung-Chen Wang
ORCID ID
Contact details
Kaohsiung Chang Gung Memorial Hospital
123
Ta Pei Road
Niao Sung Dist
Kaohsiung
83305
Taiwan
+886 (0)7 7317123 ext 8011
m82whc@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CMRPG8D1391
Study information
Scientific title
Early 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
Acronym
Study hypothesis
Hypothesis: 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
Chang Gung Memorial Hospital (TAIWAN), 13/01/2015, ref: 103-5218B
Study design
Single-centre interventional longitudinal case-control study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Acute spinal cord injury
Intervention
Rehabilitation 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 type
Device
Phase
Drug names
Primary outcome measure
Measured 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 measures
Measured 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 trial start date
01/02/2015
Overall trial end date
31/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. 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
Recruitment start date
21/04/2015
Recruitment end date
31/01/2018
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung
83305
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital
Sponsor details
123
Ta Pei Road
Niao Sung Dist.
Kaohsiung
83305
Taiwan
+886 (0)7 7317123
m82whc@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Memorial Hospital, Linkou
Alternative name(s)
Linkou Chang Gung Memorial Hospital
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Taiwan
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/01/2019
Participant level data
Other
Basic results (scientific)
Publication list