Clinical trial NCT03689023: Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury
Official title: Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Cardiovascular Diseases
Health Promotion
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Metropolitan University College
First posted: 2018-09-28
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: VO2peak
timeFrame: Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge
Secondary outcomes:
measure: Body Mass Index
timeFrame: At admission
measure: Body Mass Index
timeFrame: At discharge in average 4-6 months after admission
measure: Body Mass Index
timeFrame: At follow up 6 months after discharge
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At admission
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At discharge in average 4-6 months after admission
measure: International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: At follow up 6 months after discharge
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
timeFrame: At admission
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
timeFrame: At discharge in average 4-6 months after admission
measure: Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
timeFrame: At follow up 6 months after discharge
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At admission
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At discharge in average 4-6 months after admission
measure: The Exercise Self Efficacy Scale for people with Spinal Cord Injury
timeFrame: At follow up 6 months after discharge
measure: Dual energy x-ray absorbtiometry (Dexa)
timeFrame: At admission
measure: Dual energy x-ray absorbtiometry (Dexa)
timeFrame: At follow up 6 months after discharge
measure: Blood pressure
timeFrame: At admission
measure: Blood pressure
timeFrame: At discharge in average 4-6 months after admission
measure: Blood pressure
timeFrame: At follow up 6 months after discharge
measure: The 9-item Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: At discharge in average 4-6 months after admission
measure: Triglycerides
timeFrame: At admission
measure: Triglycerides
timeFrame: At discharge in average 4-6 months after admission
measure: Triglycerides
timeFrame: At follow up 6 months after discharge
measure: Cholesterol
timeFrame: At admission
measure: Cholesterol
timeFrame: At discharge in average 4-6 months after admission
measure: Cholesterol
timeFrame: At follow up 6 months after discharge
measure: HemoglobinA1c
timeFrame: At admission
measure: HemoglobinA1c
timeFrame: At discharge in average 4-6 months after admission
measure: HemoglobinA1c
timeFrame: At follow up 6 months after discharge
measure: C - reactive protein (CRP)
timeFrame: At admission
measure: C - reactive protein (CRP)
timeFrame: At discharge in average 4-6 months after admission
measure: C - reactive protein (CRP)
timeFrame: At follow up 6 months after discharge
Other outcomes:
measure: Spinal Cord Injury Independence Measure III
timeFrame: At admission
measure: Spinal Cord Injury Independence Measure III
timeFrame: At discharge in average 4-6 months after admission
measure: Spinal Cord Injury Independence Measure III
timeFrame: At follow up 6 months after discharge
measure: Patient Health Questionnaire- 2
timeFrame: At admission
measure: Patient Health Questionnaire- 2
timeFrame: At discharge in average 4-6 months after admission
measure: Patient Health Questionnaire- 2
timeFrame: At follow up 6 months after discharge
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At admission
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At discharge in average 4-6 months after admission
measure: The International SCI Quality of Life Basic Data Set
timeFrame: At follow up 6 months after discharge
measure: Objective physical activity (accelerometry)
timeFrame: At admission
measure: Objective physical activity (accelerometry)
timeFrame: At follow up 6 months after discharge
measure: Objective physical activity (accelerometry)
timeFrame: At discharge in average 4-6 months after admission
measure: The Nordic monitoring of diet, physical activity and overweight (NORMON)
timeFrame: At admission
measure: The Nordic monitoring of diet, physical activity and overweight (NORMON)
timeFrame: At discharge in average 4-6 months after admission
measure: The Nordic monitoring of diet, physical activity and overweight (NORMON)
timeFrame: At follow up 6 months after discharge
Locations:
city: Hornbæk
country: Denmark
facility: Clinic for Spinal Cord Injuries, Rigshopitalet
Study officials:
References:
citation: 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.