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Clinical Trials/NCT03689023
NCT03689023
Completed
Not Applicable

Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.

Rigshospitalet, Denmark1 site in 1 country97 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Rigshospitalet, Denmark
Enrollment
97
Locations
1
Primary Endpoint
VO2peak
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

This clinical intervention study will investigate the effectiveness of a uniform and systematic institutional strategy incorporating targeted strategic 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 compared to a historic control group. Test - retest reliability of four different VO2 peak tests and a multi sensor accelerometer respectively will be assessed as well.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicolaj Jersild Holm

Principal investigator

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

VO2peak

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

Measures peak oxygen consumption in ml/kg/min

Secondary Outcomes

  • Triglycerides(At follow up 6 months after discharge)
  • HemoglobinA1c(At follow up 6 months after discharge)
  • Body Mass Index(At follow up 6 months after discharge)
  • The 9-item Shared Decision Making Questionnaire (SDM-Q-9)(At discharge in average 4-6 months after admission)
  • The Exercise Self Efficacy Scale for people with Spinal Cord Injury(At follow up 6 months after discharge)
  • Blood pressure(At follow up 6 months after discharge)
  • Cholesterol(At follow up 6 months after discharge)
  • International Standards for Neurological Classification of Spinal Cord Injury(At follow up 6 months after discharge)
  • Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury(At follow up 6 months after discharge)
  • Dual energy x-ray absorbtiometry (Dexa)(At follow up 6 months after discharge)
  • C - reactive protein (CRP)(At follow up 6 months after discharge)

Study Sites (1)

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