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Trial record 47 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Prospective Survey of Body Mass Index in People With Spinal Cord Injury.

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ClinicalTrials.gov Identifier: NCT03369080
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Metropolitan University College
Spinal Cord Injury Centre of Western Denmark
Information provided by (Responsible Party):
Nicolaj Jersild Holm, Rigshospitalet, Denmark

Brief Summary:
This study is a prospective national survey of body mass index, and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Center of Western Denmark during a period of 9 months. Informed consent is retrieved from all participants.

Condition or disease
Spinal Cord Injuries

Detailed Description:
The current study is a sub- study in a Ph.D project containing 4 sub- studies. The protocol for the current study includes all four sub- studies, and each of the other three sub- studies will be registered ongoing individually. The current study is a prospective national survey of body mass index (BMI), and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet (CSCI) and Spinal Cord Injury Center of Western Denmark during a period of 9 months whereby 100 patients are expected to participate. Data are collected at admission and discharge. At CSCI BMI is collected every 6 weeks and all outcome measures will also be collected at follow up 6 months after discharge. A VO2peak test at discharge is performed as well, and in some participants accelerometry is performed in order to describe the amount and intensity of physical activity. Test- retest reliability of the VO2peak test and accelerometry is investigated as well. Patients with a new Spinal Cord Injury within the last 12 months, who are admitted for rehabilitation several months after the time of injury are also included in the prospective survey. Therefore the data for BMI at the time of injury is collected for all patients at admission to primary rehabilitation from both the patient journal and also by asking the patient about weight and height at the time of injury

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Representative National Survey of Body Mass Index in People With Spinal Cord Injury.
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Danish National Cohort
This study includes all patients with a new Spinal Cord Injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet or Spinal Cord Injury Center of Western Denmark



Primary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: Change from baseline to follow-up 6 months after discharge from primary rehabilitation ]
    Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2


Other Outcome Measures:
  1. 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. The International Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Association Impairment Scale

  2. International Standards for Neurological Classification of Spinal Cord Injury [ Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation ]
    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. TheInternational Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Association Impairment Scale

  3. 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. The International Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Associationment Impairment Scale

  4. Spinal Cord Injury Independence Measure III [ Time Frame: At admission ]
    The Spinal Cord Injury Independence Measure III 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.

  5. Spinal Cord Injury Independence Measure III [ Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation ]
    The Spinal Cord Injury Independence Measure III 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.

  6. Spinal Cord Injury Independence Measure III [ Time Frame: At follow up 6 months after discharge ]
    The Spinal Cord Injury Independence Measure III 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.

  7. Patient Health Questionnaire- 2 [ Time Frame: At admission ]
    The Patient Health Questionnaire- 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.

  8. Patient Health Questionnaire- 2 [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Patient Health Questionnaire- 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.

  9. Patient Health Questionnaire- 2 [ Time Frame: At follow up 6 months after discharge ]
    The Patient Health Questionnaire- 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.

  10. 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

  11. The International SCI Quality of Life Basic Data Set [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological health

  12. 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

  13. 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.

  14. Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury ( [ Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation ]
    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.

  15. 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.

  16. 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.

  17. The Exercise Self Efficacy Scale for people with Spinal Cord Injury [ Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation ]
    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.

  18. 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.

  19. VO2peak [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Measures the maximal oxygen consumption in ml/kg/min

  20. Objective physical activity (accelerometry) [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Is measured with a multisensor device recording accelerations and heart rate.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newly injured patients with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark
Criteria

Inclusion Criteria:

  • All newly injured patients with Spinal Cord Injury (within the last 12 months)admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark, are included regardless of age, neurological level of lesion and completeness of the injury if informed consent is retrieved.

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): NCT03369080


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 Recruiting
Hornbæk, Denmark, 3100
Contact: Nicolaj J Holm, Ph.D student    +45 38 63 19 32    nicolaj.jersild.holm@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Metropolitan University College
Spinal Cord Injury Centre of Western Denmark
Investigators
Principal Investigator: Nicolaj J Holm, Ph.D student Rigshopitalet, Clinic for Spinal Cord Injuries
  Study Documents (Full-Text)

Documents provided by Nicolaj Jersild Holm, Rigshospitalet, Denmark:
Study Protocol  [PDF] December 4, 2017


Responsible Party: Nicolaj Jersild Holm, Ph.D student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03369080     History of Changes
Other Study ID Numbers: sub project 1
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
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:
Body Mass Index

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