Spinal Cord Injuries
Conditions
Keywords
Cardiovascular Diseases, Health Promotion
Brief summary
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
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.
Interventions
OTHERA controlled multimodal intervention
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
Sponsors
Metropolitan University College
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2peak | Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge | Measures peak oxygen consumption in ml/kg/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Exercise Self Efficacy Scale for people with Spinal Cord Injury | At admission | 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. |
| The 9-item Shared Decision Making Questionnaire (SDM-Q-9) | At discharge in average 4-6 months after admission | 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. |
| Triglycerides | At admission | Assessment of plasma triglycerides in mmol/l |
| Cholesterol | At admission | Assessment of cholesterol in mmol/l |
| HemoglobinA1c | At admission | A marker for carbohydrate metabolism measured in mmol/mol |
| C - reactive protein (CRP) | At admission | A clinical biomarker that signposts non-specific inflammation measured in Mg/L |
| Body Mass Index | At admission | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2 |
| International Standards for Neurological Classification of Spinal Cord Injury | At admission | 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 |
| Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury | At admission | 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. |
| Dual energy x-ray absorbtiometry (Dexa) | At admission | Assessment of lean body mass percentage |
| Blood pressure | At admission | Assessment of both systolic and diastolic blood pressure in mm/ Hg |
Other
| Measure | Time frame | Description |
|---|---|---|
| The International SCI Quality of Life Basic Data Set | At admission | Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological Health. 0 indicates a worse score and 10 indicates a better score. |
| Objective physical activity (accelerometry) | At admission | Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min. |
| The Nordic monitoring of diet, physical activity and overweight (NORMON) | At admission | The questionnaire Is used to measure the course in dietary habits and explores how often 16 food indicators are consumed. The food indicators are chosen in a way that reflects the diets nutritional quality. An association between the frequency of food indicator intake and the overall nutritional value of the diet is present. Several of the chosen food indicators are recommended in the national nutritional recommendations. |
| Patient Health Questionnaire- 2 | At admission | The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks Score range is from from 0- 3, with 0 indicating a better score. Total score ranges from 0 (minimum score to 6 (maximum score), with 0 indicating a better score and with a cut-off score of 3 as the cut point for screening purposes. |
| Spinal Cord Injury Independence Measure III | At admission | The SCIM is composed of 19 items that assess 3 domains.1 Self-care (6 items, scores range from 0-20). 2 Respiration and sphincter management (4 items, scores range from 0-40). 3 Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100. |
Countries
Denmark
Outcome results
None listed