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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369080
• Other study ID #: sub project 1
• Status: Completed
• Start date: November 3, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Denmark	Clinic for Spinal Cord Injuries, Rigshopitalet	Hornbæk

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Metropolitan University College, Spinal Cord Injury Centre of Western Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	VO2peak	Measures the maximal oxygen consumption in ml/kg/min	At discharge in average 4- 6 months after admission to primary rehabilitation
Other	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
Primary	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