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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689023
• Other study ID #: Primary study
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• A 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

Locations

Country	Name	City	State
Denmark	Clinic for Spinal Cord Injuries, Rigshopitalet	Hornbæk

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Metropolitan University College

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spinal Cord Injury Independence Measure III	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.	At admission
Other	Spinal Cord Injury Independence Measure III	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.	At discharge in average 4-6 months after admission
Other	Spinal Cord Injury Independence Measure III	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.	At follow up 6 months after discharge
Other	Patient Health Questionnaire- 2	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.	At admission
Other	Patient Health Questionnaire- 2	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.	At discharge in average 4-6 months after admission
Other	Patient Health Questionnaire- 2	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.	At follow up 6 months after discharge
Other	The International SCI Quality of Life Basic Data Set	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.	At admission
Other	The International SCI Quality of Life Basic Data Set	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.	At discharge in average 4-6 months after admission
Other	The International SCI Quality of Life Basic Data Set	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.	At follow up 6 months after discharge
Other	Objective physical activity (accelerometry)	Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.	At admission
Other	Objective physical activity (accelerometry)	Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..	At follow up 6 months after discharge
Other	Objective physical activity (accelerometry)	Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..	At discharge in average 4-6 months after admission
Other	The Nordic monitoring of diet, physical activity and overweight (NORMON)	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.	At admission
Other	The Nordic monitoring of diet, physical activity and overweight (NORMON)	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.	At discharge in average 4-6 months after admission
Other	The Nordic monitoring of diet, physical activity and overweight (NORMON)	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.	At follow up 6 months after discharge
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dual energy x-ray absorbtiometry (Dexa)	Assessment of lean body mass percentage	At admission
Secondary	Dual energy x-ray absorbtiometry (Dexa)	Assessment of lean body mass percentage	At follow up 6 months after discharge
Secondary	Blood pressure	Assessment of both systolic and diastolic blood pressure in mm/ Hg	At admission
Secondary	Blood pressure	Assessment of both systolic and diastolic blood pressure in mm/ Hg	At discharge in average 4-6 months after admission
Secondary	Blood pressure	Assessment of both systolic and diastolic blood pressure in mm/ Hg	At follow up 6 months after discharge
Secondary	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
Secondary	Triglycerides	Assessment of plasma triglycerides in mmol/l	At admission
Secondary	Triglycerides	Assessment of plasma triglycerides in mmol/l	At discharge in average 4-6 months after admission
Secondary	Triglycerides	Assessment of plasma triglycerides in mmol/l	At follow up 6 months after discharge
Secondary	Cholesterol	Assessment of cholesterol in mmol/l	At admission
Secondary	Cholesterol	Assessment of cholesterol in mmol/l	At discharge in average 4-6 months after admission
Secondary	Cholesterol	Assessment of cholesterol in mmol/l	At follow up 6 months after discharge
Secondary	HemoglobinA1c	A marker for carbohydrate metabolism measured in mmol/mol	At admission
Secondary	HemoglobinA1c	A marker for carbohydrate metabolism measured in mmol/mol	At discharge in average 4-6 months after admission
Secondary	HemoglobinA1c	A marker for carbohydrate metabolism measured in mmol/mol	At follow up 6 months after discharge
Secondary	C - reactive protein (CRP)	A clinical biomarker that signposts non-specific inflammation measured in Mg/L	At admission
Secondary	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
Secondary	C - reactive protein (CRP)	A clinical biomarker that signposts non-specific inflammation measured in Mg/L	At follow up 6 months after discharge