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

February 14, 2023 updated by: Nicolaj Jersild Holm, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Hornbæk, Denmark, 3100
        • Clinic for Spinal Cord Injuries, Rigshopitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: A controlled multimodal intervention
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: At admission
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
At admission
Body Mass Index
Time Frame: At discharge in average 4-6 months after admission
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
At discharge in average 4-6 months after admission
Body Mass Index
Time Frame: 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
At follow up 6 months after discharge
International Standards for Neurological Classification of Spinal Cord Injury
Time Frame: At admission
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
At admission
International Standards for Neurological Classification of Spinal Cord Injury
Time Frame: At discharge in average 4-6 months after admission
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
At discharge in average 4-6 months after admission
International Standards for Neurological Classification of Spinal Cord Injury
Time Frame: 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
At follow up 6 months after discharge
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Time Frame: At admission
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.
At admission
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Time Frame: At discharge in average 4-6 months after admission
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.
At discharge in average 4-6 months after admission
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Time Frame: 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.
At follow up 6 months after discharge
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Time Frame: At admission
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.
At admission
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Time Frame: At discharge in average 4-6 months after admission
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.
At discharge in average 4-6 months after admission
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Time Frame: 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.
At follow up 6 months after discharge
Dual energy x-ray absorbtiometry (Dexa)
Time Frame: At admission
Assessment of lean body mass percentage
At admission
Dual energy x-ray absorbtiometry (Dexa)
Time Frame: At follow up 6 months after discharge
Assessment of lean body mass percentage
At follow up 6 months after discharge
Blood pressure
Time Frame: At admission
Assessment of both systolic and diastolic blood pressure in mm/ Hg
At admission
Blood pressure
Time Frame: At discharge in average 4-6 months after admission
Assessment of both systolic and diastolic blood pressure in mm/ Hg
At discharge in average 4-6 months after admission
Blood pressure
Time Frame: At follow up 6 months after discharge
Assessment of both systolic and diastolic blood pressure in mm/ Hg
At follow up 6 months after discharge
The 9-item Shared Decision Making Questionnaire (SDM-Q-9)
Time Frame: 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.
At discharge in average 4-6 months after admission
Triglycerides
Time Frame: At admission
Assessment of plasma triglycerides in mmol/l
At admission
Triglycerides
Time Frame: At discharge in average 4-6 months after admission
Assessment of plasma triglycerides in mmol/l
At discharge in average 4-6 months after admission
Triglycerides
Time Frame: At follow up 6 months after discharge
Assessment of plasma triglycerides in mmol/l
At follow up 6 months after discharge
Cholesterol
Time Frame: At admission
Assessment of cholesterol in mmol/l
At admission
Cholesterol
Time Frame: At discharge in average 4-6 months after admission
Assessment of cholesterol in mmol/l
At discharge in average 4-6 months after admission
Cholesterol
Time Frame: At follow up 6 months after discharge
Assessment of cholesterol in mmol/l
At follow up 6 months after discharge
HemoglobinA1c
Time Frame: At admission
A marker for carbohydrate metabolism measured in mmol/mol
At admission
HemoglobinA1c
Time Frame: At discharge in average 4-6 months after admission
A marker for carbohydrate metabolism measured in mmol/mol
At discharge in average 4-6 months after admission
HemoglobinA1c
Time Frame: At follow up 6 months after discharge
A marker for carbohydrate metabolism measured in mmol/mol
At follow up 6 months after discharge
C - reactive protein (CRP)
Time Frame: At admission
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
At admission
C - reactive protein (CRP)
Time Frame: At discharge in average 4-6 months after admission
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
At discharge in average 4-6 months after admission
C - reactive protein (CRP)
Time Frame: At follow up 6 months after discharge
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
At follow up 6 months after discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spinal Cord Injury Independence Measure III
Time Frame: At admission
The SCIM is composed of 19 items that assess 3 domains.1 Self-care (6 items, scores range from 0-20). 2 Respiration and sphincter management (4 items, scores range from 0-40). 3 Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100.
At admission
Spinal Cord Injury Independence Measure III
Time Frame: At discharge in average 4-6 months after admission
The SCIM is composed of 19 items that assess 3 domains.1 Self-care (6 items, scores range from 0-20). 2 Respiration and sphincter management (4 items, scores range from 0-40). 3 Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100.
At discharge in average 4-6 months after admission
Spinal Cord Injury Independence Measure III
Time Frame: At follow up 6 months after discharge
The SCIM is composed of 19 items that assess 3 domains.1 Self-care (6 items, scores range from 0-20). 2 Respiration and sphincter management (4 items, scores range from 0-40). 3 Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100.
At follow up 6 months after discharge
Patient Health Questionnaire- 2
Time Frame: At admission
The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks Score range is from from 0- 3, with 0 indicating a better score. Total score ranges from 0 (minimum score to 6 (maximum score), with 0 indicating a better score and with a cut-off score of 3 as the cut point for screening purposes.
At admission
Patient Health Questionnaire- 2
Time Frame: At discharge in average 4-6 months after admission
The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks Score range is from from 0- 3, with 0 indicating a better score. Total score ranges from 0 (minimum score to 6 (maximum score), with 0 indicating a better score and with a cut-off score of 3 as the cut point for screening purposes.
At discharge in average 4-6 months after admission
Patient Health Questionnaire- 2
Time Frame: At follow up 6 months after discharge
The PHQ-2, comprising the first 2 items of the PHQ-9, inquires about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks Score range is from from 0- 3, with 0 indicating a better score. Total score ranges from 0 (minimum score to 6 (maximum score), with 0 indicating a better score and with a cut-off score of 3 as the cut point for screening purposes.
At follow up 6 months after discharge
The International SCI Quality of Life Basic Data Set
Time Frame: At admission
Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological Health. 0 indicates a worse score and 10 indicates a better score.
At admission
The International SCI Quality of Life Basic Data Set
Time Frame: At discharge in average 4-6 months after admission
Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological Health. 0 indicates a worse score and 10 indicates a better score.
At discharge in average 4-6 months after admission
The International SCI Quality of Life Basic Data Set
Time Frame: At follow up 6 months after discharge
Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological Health. 0 indicates a worse score and 10 indicates a better score.
At follow up 6 months after discharge
Objective physical activity (accelerometry)
Time Frame: At admission
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min.
At admission
Objective physical activity (accelerometry)
Time Frame: At discharge in average 4-6 months after admission
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..
At discharge in average 4-6 months after admission
Objective physical activity (accelerometry)
Time Frame: At follow up 6 months after discharge
Is measured with a multisensor device (Actiheart®) measuring physical activity energy expenditure in kcal/min..
At follow up 6 months after discharge
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Time Frame: At admission
The questionnaire Is used to measure the course in dietary habits and explores how often 16 food indicators are consumed. The food indicators are chosen in a way that reflects the diets nutritional quality. An association between the frequency of food indicator intake and the overall nutritional value of the diet is present. Several of the chosen food indicators are recommended in the national nutritional recommendations.
At admission
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Time Frame: At discharge in average 4-6 months after admission
The questionnaire Is used to measure the course in dietary habits and explores how often 16 food indicators are consumed. The food indicators are chosen in a way that reflects the diets nutritional quality. An association between the frequency of food indicator intake and the overall nutritional value of the diet is present. Several of the chosen food indicators are recommended in the national nutritional recommendations.
At discharge in average 4-6 months after admission
The Nordic monitoring of diet, physical activity and overweight (NORMON)
Time Frame: At follow up 6 months after discharge
The questionnaire Is used to measure the course in dietary habits and explores how often 16 food indicators are consumed. The food indicators are chosen in a way that reflects the diets nutritional quality. An association between the frequency of food indicator intake and the overall nutritional value of the diet is present. Several of the chosen food indicators are recommended in the national nutritional recommendations.
At follow up 6 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Metropolitan University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Primary study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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