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Trial record 48 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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

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ClinicalTrials.gov Identifier: NCT03689023
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Metropolitan University College
Information provided by (Responsible Party):
Nicolaj Jersild Holm, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: A controlled multimodal intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A controlled multimodal intervention
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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. Objective physical activity (accelerometry) [ Time Frame: At admission ]
    Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.

  23. 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..

  24. 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..

  25. Dual energy x-ray absorbtiometry (Dexa) [ Time Frame: At admission ]
    Assessment of lean body mass percentage

  26. Dual energy x-ray absorbtiometry (Dexa) [ Time Frame: At follow up 6 months after discharge ]
    Assessment of lean body mass percentage

  27. Blood pressure [ Time Frame: At admission ]
    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  28. Blood pressure [ Time Frame: At discharge in average 4-6 months after admission ]
    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  29. Blood pressure [ Time Frame: At follow up 6 months after discharge ]
    Assessment of both systolic and diastolic blood pressure in mm/ Hg

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. Triglycerides [ Time Frame: At admission ]
    Assessment of plasma triglycerides in mmol/l

  35. Triglycerides [ Time Frame: At discharge in average 4-6 months after admission ]
    Assessment of plasma triglycerides in mmol/l

  36. Triglycerides [ Time Frame: At follow up 6 months after discharge ]
    Assessment of plasma triglycerides in mmol/l

  37. Cholesterol [ Time Frame: At admission ]
    Assessment of cholesterol in mmol/l

  38. Cholesterol [ Time Frame: At discharge in average 4-6 months after admission ]
    Assessment of cholesterol in mmol/l

  39. Cholesterol [ Time Frame: At follow up 6 months after discharge ]
    Assessment of cholesterol in mmol/l

  40. HemoglobinA1c [ Time Frame: At admission ]
    A marker for carbohydrate metabolism measured in mmol/mol

  41. HemoglobinA1c [ Time Frame: At discharge in average 4-6 months after admission ]
    A marker for carbohydrate metabolism measured in mmol/mol

  42. HemoglobinA1c [ Time Frame: At follow up 6 months after discharge ]
    A marker for carbohydrate metabolism measured in mmol/mol

  43. C - reactive protein (CRP) [ Time Frame: At admission ]
    A clinical biomarker that signposts non-specific inflammation measured in Mg/L

  44. 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

  45. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689023


Contacts
Contact: Nicolaj J Holm, Ph.D student +45 38 63 19 32 nicolaj.jersild.holm@regionh.dk

Locations
Denmark
Clinic for Spinal Cord Injuries, Rigshopitalet
Hornbæk, Denmark, 3100
Sponsors and Collaborators
Rigshospitalet, Denmark
Metropolitan University College
  Study Documents (Full-Text)

Documents provided by Nicolaj Jersild Holm, Rigshospitalet, Denmark:

Responsible Party: Nicolaj Jersild Holm, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03689023     History of Changes
Other Study ID Numbers: Primary study
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicolaj Jersild Holm, Rigshospitalet, Denmark:
Cardiovascular Diseases
Health Promotion

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System