NCT03369080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

November 17, 2017

Last Update Submit

October 1, 2022

Conditions

Keywords

Body Mass Index

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index

    Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2

    Change from baseline to follow-up 6 months after discharge from primary rehabilitation

Other Outcomes (20)

  • International Standards for Neurological Classification of Spinal Cord Injury

    At admission

  • International Standards for Neurological Classification of Spinal Cord Injury

    At discharge in average 4-6 months after admission to primary rehabilitation

  • International Standards for Neurological Classification of Spinal Cord Injury

    At follow up 6 months after discharge

  • +17 more other outcomes

Study Arms (1)

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

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Insufficient skills in Danish language
  • Reduced mental function that prevents reading and answering the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Spinal Cord Injuries, Rigshopitalet

Hornbæk, 3100, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nicolaj J Holm, Ph.D student

    Rigshopitalet, Clinic for Spinal Cord Injuries

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D student

Study Record Dates

First Submitted

November 17, 2017

First Posted

December 11, 2017

Study Start

November 3, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations