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

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT03369080
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-03
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-01
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index	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

Trial Locations

Locations (1)

Clinic for Spinal Cord Injuries, Rigshopitalet; 🇩🇰 Hornbæk, Denmark