The main aim of this study is to gain an in-depth knowledge of cardiopulmonary and autonomic health consequences, and related risk factors among people with long-term high-level spinal cord injury. The result of this study will form the basis for further research to improve prevention strategies and risk prediction of cardiopulmonary disorders in people with spinal cord injury.
Life expectancy for people with spinal cord injury (SCI) has increased during the 20th century as a result of improvements in health care systems and the environment. The incidence of SCI is stable and as a consequence the prevalence of SCI has increased globally leading to a growing population of persons aging with SCI. Therefore, SCI research need to focus on the physiology of aging to prevent premature cardiovascular and pulmonary diseases, which are the leading causes of death. The disruption of sensory-, motor- and autonomic pathways causes major neurological deficits which alter the physiologic conditions. Among people with SCI above the mid-thoracic level dysfunction in pulmonary, autonomic cardiovascular regulation and emerging metabolic cardiovascular risk factors are well-known. In addition, paralysis of the abdominal and thoracic musculature causes restrictive pulmonary dysfunction, weak cough and atelectasis contributing to the mortality in SCI. Cardiovascular disease (CVD) is more prevalent and occurs earlier in life among people with SCI compared to the general population. The increased prevalence of traditional risk factors cannot, however, fully explain these findings. Cardiovascular autonomic dysfunction has been hypothesized to contribute to the increased risk. The need for advances in risk management is therefore important as the first symptoms of coronary atherosclerosis are commonly sudden death or acute coronary syndrome. This is further complicated by the sensory loss and reduced ability to perform strenuous activities leading to asymptomatic disease as typical symptoms of exertional angina pectoris does not manifest. Risk assessment tools, such as Framingham risk score or Systematic Coronary Risk Evaluation (SCORE), are available but lack the precision in people with SCI as these tools are calibrated on the general population. The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment - SPICA - was initiated to assess the effects of aging with SCI on the cardiovascular, pulmonary and autonomic systems in a cohort of middle-aged persons with long-term SCI. SPICA combines advanced imaging techniques, likely to play an important role in risk stratification of CVD and pulmonary disease in the future, with functional analyses, and generic and SCI-specific assessment tools. The overarching aim of SPICA is to assess and extensively characterize the cardiopulmonary and autonomic health status in middle-aged persons with a severe and high-level SCI. The study will elucidate the cardiopulmonary health consequences specific to persons living with a SCI through comparison of results to matched controls. The results of SPICA will advance the investigator's knowledge in this field and thereby improve prevention strategies and risk prediction of CVD and pulmonary disorders in people with SCI.
Rehabilitation medicine Research Group
Lund, Sweden
Coronary artery calcium score
Measures the amount of calcium in the coronary arteries from computed tomography imaging. Scores from 0 to \>1000, a higher value represents a worse outcome. Value \>0 indicates coronary atherosclerosis.
Time frame: Day 1
Intima media thickness in the carotid arteries
Ultrasound of carotid arteries to measure intima media thickness
Time frame: Day 1
Assesses atherosclerosis in the coronary arteries
Coronary CT Angiography
Time frame: Day 1
Prevalence of structural changes in the lung tissue
High resolution CT scan
Time frame: Day 1
Ectopic fat distribution
CT body composition of epicardium, liver, abdomen and muscle
Time frame: Day 1
Heart rate response to deep breathing
Measures electrocardiography the activity of the autonomic nervous system based on the time and frequency domain indices of heart rate variability during deep breathing.
Time frame: Day 1
Orthostatic blood pressure
Measures systolic and diastolic blood pressure changes from supine position and after 3 minutes in seating position.
Time frame: Day 1
Plaques in the carotid arteries
Ultrasound of carotid arteries to measure and characterize plaques.
Time frame: Day 1
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Study Type
OBSERVATIONAL
Enrollment
125
Questionnaire
self-reported health, lifestyle, social determinants, living conditions and medical history
Time frame: Day 1
Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
Self-reported spasticity scale that measures the impact of spasticity in activities of daily living. Ranges from -105 to 105. Low values represents a worse outcome
Time frame: Day 1
Sense of Coherence Scale (SOC-13)
To assess the 3 dimensions of the SOC concept: comprehensibility (5 items), manageability (4 items), and meaningfulness (4 items). Value ranges from 13 to 91 and low values represent a worse outcome.
Time frame: Day 1
Hospital Anxiety and Depression Scale (HADS)
Screening instrument for anxiety and depression. Consists of two subscales, one for depression and one for anxiety each ranging from 0-21, high value represents a worse outcome.
Time frame: Day 1
Spinal Cord Independence Measure (SCIM III)
SCIM III comprises 19 areas of activities of daily living grouped into 3 subscales: self-care, respiratory and sphincter management, and mobility and measure self-reported activity limitation. SCIM III ranges from 0-100 and a low value represents a worse outcome.
Time frame: Day 1
Modified Ashworth Scale
Clinical examination of spasticity in specific muscles of the upper and lower extremities. The scale ranges from 0-4 with increasing scores indicating increased spasticity.
Time frame: Day 1
American Spinal Injury Association (ASIA) Impairment Scale
Measures the extent of spinal cord injury and the neurological level of injury. The extent of injury is classified as A-E. A (complete injury); B (sensory incomplete injury); C (motor incomplete injury, more than half of key muscle functions below the neurological level have a muscle grade 2 or less); D (motor incomplete injury, at least half of key muscle functions below the neurological level have a muscle grade 3 or more); E (normal sensory and motor function). i.e. from complete to normal neurological function. Thus A represents a worse outcome than E. The neurological level of injury reflects the most rostral spinal cord level with normal sensory and motor function.
Time frame: Day 1
Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI)
Measures the occurrence and severity of autonomic dysreflexia (AD) and hypotension in spinal cord injury. Consists of two subscales ranging from 0-204 (AD) and 0-232 (hypotension) and a high value represents a worse outcome.
Time frame: Day 1
Total cholesterol
Analysis of venous blood sample for total cholesterol levels
Time frame: Day 1
High density lipoproteins (HDL)
Analysis of venous blood sample for total HDL-levels
Time frame: Day 1
Low density lipoproteins (LDL)
Analysis of venous blood sample for LDL-levels
Time frame: Day 1
Triglycerides
Analysis of venous blood sample for triglycerides levels
Time frame: Day 1
Fasting plasma glucose
Analysis of venous blood sample for fasting plasma glucose level
Time frame: Day 1
Glycated hemoglobin (HbA1c)
Analysis of venous blood sample for HbA1c level
Time frame: Day 1
high sensitive C-reactive protein (hsCRP)
Analysis of venous blood sample for hsCRP level
Time frame: Day 1
Cystatin C
Analysis of venous blood sample for Cystatin C level
Time frame: Day 1
Creatinine
Analysis of venous blood sample for Creatinine level
Time frame: Day 1
Urate
Analysis of venous blood sample for Urate level
Time frame: Day 1
Hemoglobin
Analysis of venous blood sample for Hemoglobin level
Time frame: Day 1
Erythrocytes
Analysis of venous blood sample for erythrocytes level
Time frame: Day 1
Erythrocyte volume fraction (EVF)
Analysis of venous blood sample for EVF level
Time frame: Day 1
Leukocytes
Analysis of venous blood sample for leukocytes level
Time frame: Day 1
Trombocytes
Analysis of venous blood sample for trombocytes level
Time frame: Day 1
Erythrocytes Mean Corpuscular Hemoglobin (Erc-MCH)
Analysis of venous blood sample for Erc-MCH level
Time frame: Day 1
Erythrocytes Mean Corpuscular Volume (Erc-MCV)
Analysis of venous blood sample for Erc-MCV level
Time frame: Day 1
Neutrophils
Analysis of venous blood sample for neutrophils level
Time frame: Day 1
Eosinophils
Analysis of venous blood sample for Eosinophils level
Time frame: Day 1
Basophils
Analysis of venous blood sample for Basophils level
Time frame: Day 1
Lymphocytes
Analysis of venous blood sample for lymphocytes level
Time frame: Day 1
Monocytes
Analysis of venous blood sample for monocytes level
Time frame: Day 1
Absolute glomerular filtration rate (GFR)
Calculated absolute GFR from Cystatin C level, body height, body weight, age and gender.
Time frame: Day 1
Body weight
Recorded in kilograms with a portable scale for wheelchairs.
Time frame: Day 1
Body height
Recorded in centimeters in supine position using a flexible measure tape
Time frame: Day 1
Waist circumference
Recorded in centimeters in supine position using a flexible measure tape
Time frame: Day 1
Hip circumference
Recorded in centimeters in supine position using a flexible measure tape
Time frame: Day 1
Body mass index
Produced by dividing the body weight in kilograms with the body height in meters to the power of two
Time frame: Day 1
Accelerometry
Measures ambulatory activity for seven days
Time frame: Seven days
Resting blood pressure
Standard resting systolic and diastolic blood pressure
Time frame: Day 1
Ankle-brachial index
Measures atherosclerosis in the lower extremities by dividing the systolic blood pressure at the ankle with the systolic blood pressure of the arm.
Time frame: Day 1
Ambulatory 24-hour blood pressure
Monitors systolic and diastolic blood pressures every 30 minutes over 24 hours
Time frame: Day 1
Electrocardiography
Standard 12-lead ECG recording
Time frame: Day 1
24-hour Holter-ECG
Monitors the heart activity
Time frame: Day 1
Advanced glycation endproduct (AGE)
Measures AGE in the skin
Time frame: Day 1
Spirometry
Dynamic spirometry
Time frame: Day 1
Gas diffusing capacity (DLCO)
Measures diffusing capacity of the lungs using the single breath method
Time frame: Day 1
Impulse oscillometry
Measures lung mechanics
Time frame: Day 1
Arterial stiffness
Estimated by pulse wave analysis
Time frame: Day 1
Arterial stiffness
Measured using pulse wave velocity
Time frame: Day 1