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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03369080
Enrollment
98
Registered
2017-12-11
Start date
2017-11-03
Completion date
2019-05-31
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Body Mass Index

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

Interventions

None listed

Sponsors

Metropolitan University College
CollaboratorOTHER
Spinal Cord Injury Centre of Western Denmark
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Mass IndexChange from baseline to follow-up 6 months after discharge from primary rehabilitationDefined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2

Other

MeasureTime frameDescription
Spinal Cord Injury Independence Measure IIIAt admissionThe 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- 2At admissionThe 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 SetAt admissionConsists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological health
International Standards for Neurological Classification of Spinal Cord InjuryAt admissionThe 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
The Exercise Self Efficacy Scale for people with Spinal Cord InjuryAt admissionA 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.
VO2peakAt discharge in average 4- 6 months after admission to primary rehabilitationMeasures the maximal oxygen consumption in ml/kg/min
Objective physical activity (accelerometry)At discharge in average 4- 6 months after admission to primary rehabilitationIs measured with a multisensor device recording accelerations and heart rate.
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury (At admissionQuestionnaire 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026