Spinal Cord InjuriesNCT03689023
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury
A study of Spinal Cord Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet.
Who cannot join
- Insufficient skills in Danish language
- Reduced mental function that prevents reading and answering the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- A controlled multimodal intervention
- Keywords
- Cardiovascular Diseases, Health Promotion
- Medical subject headings
- Spinal Cord Injuries, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: A controlled multimodal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Measures peak oxygen consumption in ml/kg/min
Measured: 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
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Measured: At admission
Body Mass Index
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Measured: At discharge in average 4-6 months after admission
Body Mass Index
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Measured: At follow up 6 months after discharge
International Standards for Neurological Classification of Spinal Cord Injury
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
Measured: At admission
International Standards for Neurological Classification of Spinal Cord Injury
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
Measured: At discharge in average 4-6 months after admission
International Standards for Neurological Classification of Spinal Cord Injury
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
Measured: At follow up 6 months after discharge
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
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.
Measured: At admission
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
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.
Measured: At discharge in average 4-6 months after admission
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
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.
Measured: At follow up 6 months after discharge
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
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.
Measured: At admission
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
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.
Measured: At discharge in average 4-6 months after admission
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
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.
Measured: At follow up 6 months after discharge
Dual energy x-ray absorbtiometry (Dexa)
Assessment of lean body mass percentage
Measured: At admission
Dual energy x-ray absorbtiometry (Dexa)
Assessment of lean body mass percentage
Measured: At follow up 6 months after discharge
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Measured: At admission
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Measured: At discharge in average 4-6 months after admission
Blood pressure
Assessment of both systolic and diastolic blood pressure in mm/ Hg
Measured: At follow up 6 months after discharge
The 9-item Shared Decision Making Questionnaire (SDM-Q-9)
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.
Measured: At discharge in average 4-6 months after admission
Triglycerides
Assessment of plasma triglycerides in mmol/l
Measured: At admission
Triglycerides
Assessment of plasma triglycerides in mmol/l
Measured: At discharge in average 4-6 months after admission
Triglycerides
Assessment of plasma triglycerides in mmol/l
Measured: At follow up 6 months after discharge
Cholesterol
Assessment of cholesterol in mmol/l
Measured: At admission
Cholesterol
Assessment of cholesterol in mmol/l
Measured: At discharge in average 4-6 months after admission
Cholesterol
Assessment of cholesterol in mmol/l
Measured: At follow up 6 months after discharge
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
Measured: At admission
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
Measured: At discharge in average 4-6 months after admission
HemoglobinA1c
A marker for carbohydrate metabolism measured in mmol/mol
Measured: At follow up 6 months after discharge
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Measured: At admission
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Measured: At discharge in average 4-6 months after admission
C - reactive protein (CRP)
A clinical biomarker that signposts non-specific inflammation measured in Mg/L
Measured: At follow up 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan University College
- Responsible party
- Principal investigator, Nicolaj Jersild Holm, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689023
- Sponsor's protocol ID
- Primary study
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31892644
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury: Physical Activity, Healthy Diet and Maintenance After Discharge.
- ClinicalTrials.gov ID
- NCT03689023
- Acronym / sponsor ID
- Primary study
- Conditions
- Spinal Cord Injuries
- Keywords
- Cardiovascular Diseases, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Metropolitan University College
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A controlled multimodal intervention | Experimental | Other: A controlled multimodal interventionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet.
Key exclusion criteria (2 listed)
- Insufficient skills in Danish language
- Reduced mental function that prevents reading and answering the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A controlled multimodal interventionThe 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 | Other | A controlled multimodal intervention |
Primary outcome
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
30 secondary outcomes
Body Mass Index
Time frame: At admission
Body Mass Index
Time frame: At discharge in average 4-6 months after admission
Body Mass Index
Time frame: At follow up 6 months after discharge
International Standards for Neurological Classification of Spinal Cord Injury
Time frame: At admission
International Standards for Neurological Classification of Spinal Cord Injury
Time frame: 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
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Time frame: At admission
Leisure Time Physical Activity Questionnaire for people with Spinal Cord Injury
Time frame: 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
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Time frame: At admission
The Exercise Self Efficacy Scale for people with Spinal Cord Injury
Time frame: 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
Dual energy x-ray absorbtiometry (Dexa)
Time frame: At admission
Dual energy x-ray absorbtiometry (Dexa)
Time frame: At follow up 6 months after discharge
Blood pressure
Time frame: At admission
Blood pressure
Time frame: At discharge in average 4-6 months after admission
Blood pressure
Time frame: 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
Triglycerides
Time frame: At admission
Triglycerides
Time frame: At discharge in average 4-6 months after admission
Triglycerides
Time frame: At follow up 6 months after discharge
Cholesterol
Time frame: At admission
Cholesterol
Time frame: At discharge in average 4-6 months after admission
Cholesterol
Time frame: At follow up 6 months after discharge
HemoglobinA1c
Time frame: At admission
HemoglobinA1c
Time frame: At discharge in average 4-6 months after admission
HemoglobinA1c
Time frame: At follow up 6 months after discharge
C - reactive protein (CRP)
Time frame: At admission
C - reactive protein (CRP)
Time frame: At discharge in average 4-6 months after admission
C - reactive protein (CRP)
Time frame: At follow up 6 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 31892644Holm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spinal Cord Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: Assessing change from admission to discharge in average 4-6 months after admission and follow up 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.