Clinic for Spinal Cord Injuries, Rigshopitalet
Hornbæk, 3100, Denmark
NCT Number: NCT03689023
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hornbæk, 3100, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: At admission
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Time frame: At discharge in average 4-6 months after admission
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Time frame: At follow up 6 months after discharge
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Time frame: 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
Time frame: At discharge in average 4-6 months after 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
Time frame: At follow up 6 months after discharge
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
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Time frame: At admission
Assessment of lean body mass percentage
Time frame: At follow up 6 months after discharge
Assessment of lean body mass percentage
Time frame: At admission
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time frame: At discharge in average 4-6 months after admission
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time frame: At follow up 6 months after discharge
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time frame: 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.
Time frame: At admission
Assessment of plasma triglycerides in mmol/l
Time frame: At discharge in average 4-6 months after admission
Assessment of plasma triglycerides in mmol/l
Time frame: At follow up 6 months after discharge
Assessment of plasma triglycerides in mmol/l
Time frame: At admission
Assessment of cholesterol in mmol/l
Time frame: At discharge in average 4-6 months after admission
Assessment of cholesterol in mmol/l
Time frame: At follow up 6 months after discharge
Assessment of cholesterol in mmol/l
Time frame: At admission
A marker for carbohydrate metabolism measured in mmol/mol
Time frame: At discharge in average 4-6 months after admission
A marker for carbohydrate metabolism measured in mmol/mol
Time frame: At follow up 6 months after discharge
A marker for carbohydrate metabolism measured in mmol/mol
Time frame: At admission
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time frame: At discharge in average 4-6 months after admission
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time frame: At follow up 6 months after discharge
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Time frame: At admission
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.
Time frame: At follow up 6 months after discharge
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..
Time frame: At discharge in average 4-6 months after admission
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..
Time frame: 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.
Time frame: At discharge in average 4-6 months after 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.
Time frame: At follow up 6 months after discharge
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.
Rigshospitalet, Denmark
Other
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
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