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NCT Number: NCT03369080

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

1 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Spinal Cord Injuries, Rigshopitalet

Hornbæk, 3100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Metropolitan University College
  • Spinal Cord Injury Centre of Western Denmark

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2017
Registry last updated
Oct 4, 2022

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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