Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury

Study Overview
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Brief Summary
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This study is a controlled pragmatic implementation study in clinical practice, with a primary focus on cardiovascular risk reduction through adherence to behavioral interventions related to physical activity and healthy diet.The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the clinic, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education.

Detailed Description
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This clinical intervention study will investigate the effectiveness of a uniform and systematic institutional strategy incorporating targeted strategic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process with 6 months of follow up compared to a historic control group. Test - retest reliability of four different VO2 peak tests and a multi sensor accelerometer respectively will be assessed as well.

Official Title
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Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: A controlled multimodal intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet. Exclusion Criteria: Insufficient skills in Danish language Reduced mental function that prevents reading and answering the questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A controlled multimodal intervention<br>A uniform and systematic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process with 6 months of follow up. | Other: A controlled multimodal intervention<br>* The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the Clinic as well as new interventions, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak | Measures peak oxygen consumption in ml/kg/min | Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2 | At admission | 
| Body Mass Index | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2 | At discharge in average 4-6 months after admission | 
| Body Mass Index | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2 | At follow up 6 months after discharge | 
| International Standards for Neurological Classification of Spinal Cord Injury | The classification tool involves a sensory and motor examination to determine the neurological level of the injury and whether the injury is complete or incomplete. It defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded from A to E according to the American Spinal Injury Assosciation Impairment Scale (AIS). Grade A indicates a worse score and E indicates a better score | At admission | 
| International Standards for Neurological Classification of Spinal Cord Injury | The classification tool involves a sensory and motor examination to determine the neurological level of the injury and whether the injury is complete or incomplete. It defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded from A to E according to the American Spinal Injury Assosciation Impairment Scale (AIS). Grade A indicates a worse score and E indicates a better score | At discharge in average 4-6 months after admission | 
| International Standards for Neurological Classification of Spinal Cord Injury | The classification tool involves a sensory and motor examination to determine the neurological level of the injury and whether the injury is complete or incomplete. It defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded from A to E according to the American Spinal Injury Assosciation Impairment Scale (AIS). Grade A indicates a worse score and E indicates a better score | At follow up 6 months after discharge | 
| Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury | Questionnaire concerning the amount of leisure time physical activity the past 7 days. The patient describes how many of the last 7 days and for how many minutes he/she has been physical active and also the intensity of the activity described as mild, moderate or vigorous. Higher values related to days, minutes and intensity represent a better outcome and lower values represent a worse outcome.On the scale related to days, 0 is a minimum score and 7 is a maximum score. | At admission | 
| Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury | Questionnaire concerning the amount of leisure time physical activity the past 7 days. The patient describes how many of the last 7 days and for how many minutes he/she has been physical active and also the intensity of the activity described as mild, moderate or vigorous. Higher values related to days, minutes and intensity represent a better outcome and lower values represent a worse outcome.On the scale related to days, 0 is a minimum score and 7 is a maximum score. | At discharge in average 4-6 months after admission | 
| Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury | Questionnaire concerning the amount of leisure time physical activity the past 7 days. The patient describes how many of the last 7 days and for how many minutes he/she has been physical active and also the intensity of the activity described as mild, moderate or vigorous. Higher values related to days, minutes and intensity represent a better outcome and lower values represent a worse outcome.On the scale related to days, 0 is a minimum score and 7 is a maximum score. | At follow up 6 months after discharge | 
| The Exercise Self Efficacy Scale for people with Spinal Cord Injury | A questionnaire with a 4-point rating scale describing how confident persons with spinal cord injury are with regard to carrying out regular physical activities and exercise. The questionnaire consists of 10 items with corresponding response options on a 4-point Likert scale (1-not at all true, 4-always true) with 1 indicating a worse score and 4 indicating a better score. The total score is derived by summing the scores for the individual items with a possible score range from 10 to 40. | At admission | 
| The Exercise Self Efficacy Scale for people with Spinal Cord Injury | A questionnaire with a 4-point rating scale describing how confident persons with spinal cord injury are with regard to carrying out regular physical activities and exercise. The questionnaire consists of 10 items with corresponding response options on a 4-point Likert scale (1-not at all true, 4-always true) with 1 indicating a worse score and 4 indicating a better score. The total score is derived by summing the scores for the individual items with a possible score range from 10 to 40. | At discharge in average 4-6 months after admission | 
| The Exercise Self Efficacy Scale for people with Spinal Cord Injury | A questionnaire with a 4-point rating scale describing how confident persons with spinal cord injury are with regard to carrying out regular physical activities and exercise. The questionnaire consists of 10 items with corresponding response options on a 4-point Likert scale (1-not at all true, 4-always true) with 1 indicating a worse score and 4 indicating a better score. The total score is derived by summing the scores for the individual items with a possible score range from 10 to 40. | At follow up 6 months after discharge | 
| Dual energy x-ray absorbtiometry (Dexa) | Assessment of lean body mass percentage | At admission | 
| Dual energy x-ray absorbtiometry (Dexa) | Assessment of lean body mass percentage | At follow up 6 months after discharge | 
| Blood pressure | Assessment of both systolic and diastolic blood pressure in mm/ Hg | At admission | 
| Blood pressure | Assessment of both systolic and diastolic blood pressure in mm/ Hg | At discharge in average 4-6 months after admission | 
| Blood pressure | Assessment of both systolic and diastolic blood pressure in mm/ Hg | At follow up 6 months after discharge | 
| The 9-item Shared Decision Making Questionnaire (SDM-Q-9) | The SDM-Q-9 is a questionnaire describing the process of Shared Decision Making between health care professionals and the patient from the patient's perspective and consists of nine statements, which can be rated on a six-point scale from ''completely disagree'' (0) being the worse score to ''completely agree'' (5) being the better score. Summing up all items leads to a raw total score between 0 and 45. | At discharge in average 4-6 months after admission | 
| Triglycerides | Assessment of plasma triglycerides in mmol/l | At admission | 
| Triglycerides | Assessment of plasma triglycerides in mmol/l | At discharge in average 4-6 months after admission | 
| Triglycerides | Assessment of plasma triglycerides in mmol/l | At follow up 6 months after discharge | 
| Cholesterol | Assessment of cholesterol in mmol/l | At admission | 
| Cholesterol | Assessment of cholesterol in mmol/l | At discharge in average 4-6 months after admission | 
| Cholesterol | Assessment of cholesterol in mmol/l | At follow up 6 months after discharge | 
| HemoglobinA1c | A marker for carbohydrate metabolism measured in mmol/mol | At admission | 
| HemoglobinA1c | A marker for carbohydrate metabolism measured in mmol/mol | At discharge in average 4-6 months after admission | 
| HemoglobinA1c | A marker for carbohydrate metabolism measured in mmol/mol | At follow up 6 months after discharge | 
| C - reactive protein (CRP) | A clinical biomarker that signposts non-specific inflammation measured in Mg/L | At admission | 
| C - reactive protein (CRP) | A clinical biomarker that signposts non-specific inflammation measured in Mg/L | At discharge in average 4-6 months after admission | 
| C - reactive protein (CRP) | A clinical biomarker that signposts non-specific inflammation measured in Mg/L | At follow up 6 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Health Promotion