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

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: Completed
• Conditions: Spinal Cord Injuries

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: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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. 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	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	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	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	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	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	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	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	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	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	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	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 (	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 (	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 (	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	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	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)	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

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Metropolitan University College; Spinal Cord Injury Centre of Western Denmark
• Investigators: Principal Investigator: Nicolaj J Holm, Ph.D student, Rigshopitalet, Clinic for Spinal Cord Injuries

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2017
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Body Mass Index
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID 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