Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A controlled multimodal intervention
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Cardiovascular Diseases, Health Promotion
Eligibility Criteria
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
Sites / Locations
- Clinic for Spinal Cord Injuries, Rigshopitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A controlled multimodal intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
VO2peak
Measures peak oxygen consumption in ml/kg/min
Secondary Outcome Measures
Body Mass Index
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Body Mass Index
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Body Mass Index
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
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
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
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
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.
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.
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.
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.
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.
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.
Dual energy x-ray absorbtiometry (Dexa)
Assessment of lean body mass percentage
Dual energy x-ray absorbtiometry (Dexa)
Assessment of lean body mass percentage
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
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.
Triglycerides
Assessment of plasma triglycerides in mmol/l
Triglycerides
Assessment of plasma triglycerides in mmol/l
Triglycerides
Assessment of plasma triglycerides in mmol/l
Cholesterol
Assessment of cholesterol in mmol/l
Cholesterol
Assessment of cholesterol in mmol/l
Cholesterol
Assessment of cholesterol in mmol/l
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Full Information
NCT ID
NCT03689023
First Posted
August 1, 2018
Last Updated
February 14, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Metropolitan University College
1. Study Identification
Unique Protocol Identification Number
NCT03689023
Brief Title
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury
Official Title
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Metropolitan University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Cardiovascular Diseases, Health Promotion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A controlled multimodal intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
A controlled multimodal intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
VO2peak
Description
Measures peak oxygen consumption in ml/kg/min
Time Frame
Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
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
Title
Body Mass Index
Description
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
Title
Body Mass Index
Description
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
Title
International Standards for Neurological Classification of Spinal Cord Injury
Description
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
Title
International Standards for Neurological Classification of Spinal Cord Injury
Description
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
Title
International Standards for Neurological Classification of Spinal Cord Injury
Description
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
Title
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Description
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
Title
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Description
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
Title
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Description
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
Title
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Description
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
Title
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Description
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
Title
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Description
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
Title
Dual energy x-ray absorbtiometry (Dexa)
Description
Assessment of lean body mass percentage
Time Frame
At admission
Title
Dual energy x-ray absorbtiometry (Dexa)
Description
Assessment of lean body mass percentage
Time Frame
At follow up 6 months after discharge
Title
Blood pressure
Description
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time Frame
At admission
Title
Blood pressure
Description
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time Frame
At discharge in average 4-6 months after admission
Title
Blood pressure
Description
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Time Frame
At follow up 6 months after discharge
Title
The 9-item Shared Decision Making Questionnaire (SDM-Q-9)
Description
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 discharge in average 4-6 months after admission
Title
Triglycerides
Description
Assessment of plasma triglycerides in mmol/l
Time Frame
At admission
Title
Triglycerides
Description
Assessment of plasma triglycerides in mmol/l
Time Frame
At discharge in average 4-6 months after admission
Title
Triglycerides
Description
Assessment of plasma triglycerides in mmol/l
Time Frame
At follow up 6 months after discharge
Title
Cholesterol
Description
Assessment of cholesterol in mmol/l
Time Frame
At admission
Title
Cholesterol
Description
Assessment of cholesterol in mmol/l
Time Frame
At discharge in average 4-6 months after admission
Title
Cholesterol
Description
Assessment of cholesterol in mmol/l
Time Frame
At follow up 6 months after discharge
Title
HemoglobinA1c
Description
A marker for carbohydrate metabolism measured in mmol/mol
Time Frame
At admission
Title
HemoglobinA1c
Description
A marker for carbohydrate metabolism measured in mmol/mol
Time Frame
At discharge in average 4-6 months after admission
Title
HemoglobinA1c
Description
A marker for carbohydrate metabolism measured in mmol/mol
Time Frame
At follow up 6 months after discharge
Title
C - reactive protein (CRP)
Description
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time Frame
At admission
Title
C - reactive protein (CRP)
Description
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time Frame
At discharge in average 4-6 months after admission
Title
C - reactive protein (CRP)
Description
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Time Frame
At follow up 6 months after discharge
Other Pre-specified Outcome Measures:
Title
Spinal Cord Injury Independence Measure III
Description
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
Title
Spinal Cord Injury Independence Measure III
Description
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
Title
Spinal Cord Injury Independence Measure III
Description
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
Title
Patient Health Questionnaire- 2
Description
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
Title
Patient Health Questionnaire- 2
Description
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
Title
Patient Health Questionnaire- 2
Description
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
Title
The International SCI Quality of Life Basic Data Set
Description
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
Title
The International SCI Quality of Life Basic Data Set
Description
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
Title
The International SCI Quality of Life Basic Data Set
Description
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
Title
Objective physical activity (accelerometry)
Description
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.
Time Frame
At admission
Title
Objective physical activity (accelerometry)
Description
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..
Time Frame
At follow up 6 months after discharge
Title
Objective physical activity (accelerometry)
Description
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
Title
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Description
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 admission
Title
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Description
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
Title
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinic for Spinal Cord Injuries, Rigshopitalet
City
Hornbæk
ZIP/Postal Code
3100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31892644
Citation
Holm NJ, Moller T, Adamsen L, Dalsgaard LT, Biering-Sorensen F, Schou LH. Health promotion and cardiovascular risk reduction in people with spinal cord injury: physical activity, healthy diet and maintenance after discharge- protocol for a prospective national cohort study and a preintervention- postintervention study. BMJ Open. 2019 Dec 31;9(12):e030310. doi: 10.1136/bmjopen-2019-030310.
Results Reference
derived
Learn more about this trial
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury
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