Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: A controlled multimodal intervention

• Registration Number: NCT03689023
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2018-10-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A controlled multimodal intervention	A controlled multimodal intervention	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.

Primary Outcome Measures

Name	Time	Method
VO2peak	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 Outcome Measures

Name	Time	Method
Triglycerides	At follow up 6 months after discharge	Assessment of plasma triglycerides in mmol/l
HemoglobinA1c	At follow up 6 months after discharge	A marker for carbohydrate metabolism measured in mmol/mol
Body Mass Index	At follow up 6 months after discharge	Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
The 9-item Shared Decision Making Questionnaire (SDM-Q-9)	At discharge in average 4-6 months after admission	The SDM-Q-9 is a questionnaire describing the process of Shared Decision Making between health care professionals and the patient from the patient's perspective and consists of nine statements, which can be rated on a six-point scale from ''completely disagree'' (0) being the worse score to ''completely agree'' (5) being the better score. Summing up all items leads to a raw total score between 0 and 45.
The Exercise Self Efficacy Scale for people with Spinal Cord Injury	At follow up 6 months after discharge	A 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.
Blood pressure	At follow up 6 months after discharge	Assessment of both systolic and diastolic blood pressure in mm/ Hg
Cholesterol	At follow up 6 months after discharge	Assessment of cholesterol in mmol/l
International Standards for Neurological Classification of Spinal Cord Injury	At follow up 6 months after discharge	The classification tool involves a sensory and motor examination to determine the neurological level of the injury and whether the injury is complete or incomplete. It defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded from A to E according to the American Spinal Injury Assosciation Impairment Scale (AIS). Grade A indicates a worse score and E indicates a better score
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury	At follow up 6 months after discharge	Questionnaire 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.
Dual energy x-ray absorbtiometry (Dexa)	At follow up 6 months after discharge	Assessment of lean body mass percentage
C - reactive protein (CRP)	At follow up 6 months after discharge	A clinical biomarker that signposts non-specific inflammation measured in Mg/L

Trial Locations

Locations (1)

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