Clinical trial NCT03369080: Prospective Survey of Body Mass Index in People With Spinal Cord Injury.
Official title: Prospective Representative National Survey of Body Mass Index in People With Spinal Cord Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Body Mass Index
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Metropolitan University College
name: Spinal Cord Injury Centre of Western Denmark
First posted: 2017-12-11
Enrollment: 98
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility 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

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Change from baseline to follow-up 6 months after discharge from primary rehabilitation
Secondary outcomes:
Other outcomes:
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At admission
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At discharge in average 4-6 months after admission to primary rehabilitation
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At follow up 6 months after discharge
measure: Spinal Cord Injury Independence Measure III
timeFrame: At admission
measure: Spinal Cord Injury Independence Measure III
timeFrame: At discharge in average 4-6 months after admission to primary rehabilitation
measure: Spinal Cord Injury Independence Measure III
timeFrame: At follow up 6 months after discharge
measure: Patient Health Questionnaire- 2
timeFrame: At admission
measure: Patient Health Questionnaire- 2
timeFrame: At discharge in average 4- 6 months after admission to primary rehabilitation
measure: Patient Health Questionnaire- 2
timeFrame: At follow up 6 months after discharge
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At admission
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At discharge in average 4- 6 months after admission to primary rehabilitation
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At follow up 6 months after discharge
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury (
timeFrame: At admission
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury (
timeFrame: At discharge in average 4-6 months after admission to primary rehabilitation
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury (
timeFrame: At follow up 6 months after discharge
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At admission
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At discharge in average 4-6 months after admission to primary rehabilitation
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At follow up 6 months after discharge
measure: VO2peak
timeFrame: At discharge in average 4- 6 months after admission to primary rehabilitation
measure: Objective physical activity (accelerometry)
timeFrame: At discharge in average 4- 6 months after admission to primary rehabilitation
Locations:
city: Hornbæk
country: Denmark
facility: Clinic for Spinal Cord Injuries, Rigshopitalet
Study officials:
affiliation: Rigshopitalet, Clinic for Spinal Cord Injuries
name: Nicolaj J Holm, Ph.D student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holm NJ, Moller T, Adamsen L, Dalsgaard LT, Biering-Sorensen F, Schou LH. Health promotion and cardiovascular risk reduction in people with spinal cord injury: physical activity, healthy diet and maintenance after discharge- protocol for a prospective national cohort study and a preintervention- postintervention study. BMJ Open. 2019 Dec 31;9(12):e030310. doi: 10.1136/bmjopen-2019-030310.