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Completed

NCT Number: NCT03689023

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Spinal Cord Injuries, Rigshopitalet

Hornbæk, 3100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A controlled multimodal intervention

Other

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 outcomes

  1. VO2peak

    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

Secondary outcomes

  1. Body Mass Index

    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

  2. Body Mass Index

    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

  3. Body Mass Index

    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

  4. International Standards for Neurological Classification of Spinal Cord Injury

    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

  5. International Standards for Neurological Classification of Spinal Cord Injury

    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

  6. International Standards for Neurological Classification of Spinal Cord Injury

    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

  7. Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury

    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.

  8. Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury

    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.

  9. Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury

    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.

  10. The Exercise Self Efficacy Scale for people with Spinal Cord Injury

    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.

  11. The Exercise Self Efficacy Scale for people with Spinal Cord Injury

    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.

  12. The Exercise Self Efficacy Scale for people with Spinal Cord Injury

    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.

  13. Dual energy x-ray absorbtiometry (Dexa)

    Time frame: At admission

    Assessment of lean body mass percentage

  14. Dual energy x-ray absorbtiometry (Dexa)

    Time frame: At follow up 6 months after discharge

    Assessment of lean body mass percentage

  15. Blood pressure

    Time frame: At admission

    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  16. Blood pressure

    Time frame: At discharge in average 4-6 months after admission

    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  17. Blood pressure

    Time frame: At follow up 6 months after discharge

    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  18. The 9-item Shared Decision Making Questionnaire (SDM-Q-9)

    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.

  19. Triglycerides

    Time frame: At admission

    Assessment of plasma triglycerides in mmol/l

  20. Triglycerides

    Time frame: At discharge in average 4-6 months after admission

    Assessment of plasma triglycerides in mmol/l

  21. Triglycerides

    Time frame: At follow up 6 months after discharge

    Assessment of plasma triglycerides in mmol/l

  22. Cholesterol

    Time frame: At admission

    Assessment of cholesterol in mmol/l

  23. Cholesterol

    Time frame: At discharge in average 4-6 months after admission

    Assessment of cholesterol in mmol/l

  24. Cholesterol

    Time frame: At follow up 6 months after discharge

    Assessment of cholesterol in mmol/l

  25. HemoglobinA1c

    Time frame: At admission

    A marker for carbohydrate metabolism measured in mmol/mol

  26. HemoglobinA1c

    Time frame: At discharge in average 4-6 months after admission

    A marker for carbohydrate metabolism measured in mmol/mol

  27. HemoglobinA1c

    Time frame: At follow up 6 months after discharge

    A marker for carbohydrate metabolism measured in mmol/mol

  28. C - reactive protein (CRP)

    Time frame: At admission

    A clinical biomarker that signposts non-specific inflammation measured in Mg/L

  29. C - reactive protein (CRP)

    Time frame: At discharge in average 4-6 months after admission

    A clinical biomarker that signposts non-specific inflammation measured in Mg/L

  30. C - reactive protein (CRP)

    Time frame: At follow up 6 months after discharge

    A clinical biomarker that signposts non-specific inflammation measured in Mg/L

Other outcomes

  1. Spinal Cord Injury Independence Measure III

    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.

  2. Spinal Cord Injury Independence Measure III

    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.

  3. Spinal Cord Injury Independence Measure III

    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.

  4. Patient Health Questionnaire- 2

    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.

  5. Patient Health Questionnaire- 2

    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.

  6. Patient Health Questionnaire- 2

    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.

  7. The International SCI Quality of Life Basic Data Set

    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.

  8. The International SCI Quality of Life Basic Data Set

    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.

  9. The International SCI Quality of Life Basic Data Set

    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.

  10. Objective physical activity (accelerometry)

    Time frame: At admission

    Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.

  11. Objective physical activity (accelerometry)

    Time frame: At follow up 6 months after discharge

    Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..

  12. Objective physical activity (accelerometry)

    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..

  13. The Nordic monitoring of diet, physical activity and overweight (NORMON)

    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.

  14. The Nordic monitoring of diet, physical activity and overweight (NORMON)

    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.

  15. The Nordic monitoring of diet, physical activity and overweight (NORMON)

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Metropolitan University College

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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