ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

November 17, 2017
December 11, 2017
December 12, 2017
November 3, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03369080 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • VO2peak [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Measures the maximal oxygen consumption in ml/kg/min
  • 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.
  • 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 ISNCSCI 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 ASIA Impairment Scale (AIS)
  • 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. The ISNCSCI 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 ASIA Impairment Scale (AIS)
  • 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 ISNCSCI 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 ASIA Impairment Scale (AIS)
  • 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.
  • Spinal Cord Injury Independence Measure III [ Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation ]
    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.
  • 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.
  • 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.
  • Patient Health Questionnaire- 2 [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    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.
  • 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.
  • 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
  • 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
  • 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
  • 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, modeate 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.
  • 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, modeate 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.
  • 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, modeate 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.
  • 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.
  • 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.
  • 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.
  • VO2peak [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Measures the maximal oxygen consumption in ml/kg/min
  • Objective physical activity (accelerometry) [ Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation ]
    Is measured with a multicensor device (Actiheart®) recording accelerations and heart rate.
 
Prospective Survey of Body Mass Index in People With Spinal Cord Injury.
Prospective Representative National 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.
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All newly injured patients with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark
Spinal Cord Injuries
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Year to 100 Years   (Child, Adult, Older Adult)
No
Contact: Nicolaj J Holm, Ph.D student +45 38 63 19 32 nicolaj.jersild.holm@regionh.dk
Denmark
 
 
NCT03369080
sub project 1
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Nicolaj Jersild Holm, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Metropolitan University College
  • Spinal Cord Injury Centre of Western Denmark
Principal Investigator: Nicolaj J Holm, Ph.D student Rigshopitalet, Clinic for Spinal Cord Injuries
Rigshospitalet, Denmark
December 2017