NCT03689023

Brief Summary

This study is a controlled pragmatic implementation study in clinical practice, with a primary focus on cardiovascular risk reduction through adherence to behavioral interventions related to physical activity and healthy diet.The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the clinic, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

August 1, 2018

Last Update Submit

February 14, 2023

Conditions

Spinal Cord Injuries

Keywords

Cardiovascular DiseasesHealth Promotion

Outcome Measures

Primary Outcomes (1)

  • VO2peak

    Measures peak oxygen consumption in ml/kg/min

    Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge

Secondary Outcomes (30)

  • Body Mass Index

    At admission

  • Body Mass Index

    At discharge in average 4-6 months after admission

  • Body Mass Index

    At follow up 6 months after discharge

  • 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

  • +25 more secondary outcomes

Other Outcomes (15)

  • Spinal Cord Injury Independence Measure III

    At admission

  • Spinal Cord Injury Independence Measure III

    At discharge in average 4-6 months after admission

  • Spinal Cord Injury Independence Measure III

    At follow up 6 months after discharge

  • +12 more other outcomes

Study Arms (1)

A controlled multimodal intervention

EXPERIMENTAL

A uniform and systematic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process with 6 months of follow up.

Other: A controlled multimodal intervention

Interventions

A controlled multimodal interventionOTHER

The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the Clinic as well as new interventions, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education

A controlled multimodal intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet.

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.

    PMID: 31892644DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesCardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 1, 2018

First Posted

September 28, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)