Prospective Survey of Body Mass Index in People With Spinal Cord Injury.

October 1, 2022 updated by: Nicolaj Jersild Holm, Rigshospitalet, Denmark

Prospective Representative National Survey of Body Mass Index in People With Spinal Cord Injury.

This study is a prospective national survey of body mass index, and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Center of Western Denmark during a period of 9 months. Informed consent is retrieved from all participants.

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.

Detailed Description

The current study is a sub- study in a Ph.D project containing 4 sub- studies. The protocol for the current study includes all four sub- studies, and each of the other three sub- studies will be registered ongoing individually. The current study is a prospective national survey of body mass index (BMI), and includes all patients with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet (CSCI) and Spinal Cord Injury Center of Western Denmark during a period of 9 months whereby 100 patients are expected to participate. Data are collected at admission and discharge. At CSCI BMI is collected every 6 weeks and all outcome measures will also be collected at follow up 6 months after discharge. A VO2peak test at discharge is performed as well, and in some participants accelerometry is performed in order to describe the amount and intensity of physical activity. Test- retest reliability of the VO2peak test and accelerometry is investigated as well. Patients with a new Spinal Cord Injury within the last 12 months, who are admitted for rehabilitation several months after the time of injury are also included in the prospective survey. Therefore the data for BMI at the time of injury is collected for all patients at admission to primary rehabilitation from both the patient journal and also by asking the patient about weight and height at the time of injury

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.
Observational

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.
98

Contacts and Locations

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

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

1 year to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newly injured patients with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark

Description

Inclusion Criteria:

  • All newly injured patients with Spinal Cord Injury (within the last 12 months)admitted at Clinic for Spinal Cord Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark, are included regardless of age, neurological level of lesion and completeness of the injury if informed consent is retrieved.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Danish National Cohort
This study includes all patients with a new Spinal Cord Injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet or Spinal Cord Injury Center of Western Denmark

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
Change in Body Mass Index
Time Frame: Change from baseline to follow-up 6 months after discharge from primary rehabilitation
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2
Change from baseline to follow-up 6 months after discharge from primary rehabilitation

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
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 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
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. The International Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Association Impairment Scale
At admission
International Standards for Neurological Classification of Spinal Cord Injury
Time Frame: At discharge in average 4-6 months after admission to primary rehabilitation
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. TheInternational Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Association Impairment Scale
At discharge in average 4-6 months after admission to primary rehabilitation
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. The International Standards for Neurological Classification of Spinal Cord Injury defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the American Spinal Injury Associationment Impairment Scale
At follow up 6 months after discharge
Spinal Cord Injury Independence Measure III
Time Frame: At admission
The Spinal Cord Injury Independence Measure III 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 to primary rehabilitation
The Spinal Cord Injury Independence Measure III 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 to primary rehabilitation
Spinal Cord Injury Independence Measure III
Time Frame: At follow up 6 months after discharge
The Spinal Cord Injury Independence Measure III 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 Patient Health Questionnaire- 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 to primary rehabilitation
Patient Health Questionnaire- 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 to primary rehabilitation
Patient Health Questionnaire- 2
Time Frame: At follow up 6 months after discharge
The Patient Health Questionnaire- 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
At admission
The International SCI Quality of Life Basic Data Set
Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation
Consists of three questions scored on a scale of 0-10 regarding general quality of life, physical health and satisfaction with psychological health
At discharge in average 4- 6 months after admission to primary rehabilitation
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
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 to primary rehabilitation
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 to primary rehabilitation
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 discharge in average 4-6 months after admission to primary rehabilitation
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 to primary rehabilitation
VO2peak
Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation
Measures the maximal oxygen consumption in ml/kg/min
At discharge in average 4- 6 months after admission to primary rehabilitation
Objective physical activity (accelerometry)
Time Frame: At discharge in average 4- 6 months after admission to primary rehabilitation
Is measured with a multisensor device recording accelerations and heart rate.
At discharge in average 4- 6 months after admission to primary rehabilitation

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
Spinal Cord Injury Centre of Western Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolaj J Holm, Ph.D student, Rigshopitalet, Clinic for Spinal Cord Injuries

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.
November 3, 2017

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.
May 31, 2019

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.
May 31, 2019

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).
November 17, 2017

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.
December 5, 2017

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.
December 11, 2017

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.
October 4, 2022

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.
October 1, 2022

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.
October 1, 2022

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.
  • sub project 1

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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