Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01236976
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2010-11-08
Brief Title:
SCIPA Full-On Intensive Exercise Program After Spinal Cord Injury
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
SCIPA Full-On Intensive Exercise Program After Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCIPAFull-On
Brief Summary:
The study is a multi-centre assessor-blind randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12 A total of 188 participants will be randomised into two groups the experimental group and the control group The control group participants will receive an upper body strength and fitness program conducted for 2-3 hours three times per week for 12 weeks while the experimental group participants will receive a comprehensive full body exercise program conducted for 2-3 hours three times per week for 12 weeks
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury
Total study duration is 35 years including a 24 month recruitment period a 12-week treatment period followed by 6 month and 12 month from baseline follow up assessments
Participants will be assessed by a blinded assessor the assessor will not know which group the participants are in using standard physiotherapy neurophysiological fitness and functional tests psychological and quality of life questionnaires as well as tests of immune function and bone structure
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury
Total study duration is 35 years including a 24 month recruitment period a 12-week treatment period followed by 6 month and 12 month from baseline follow up assessments
Participants will be assessed by a blinded assessor the assessor will not know which group the participants are in using standard physiotherapy neurophysiological fitness and functional tests psychological and quality of life questionnaires as well as tests of immune function and bone structure
Detailed Description:
The study is a multi-centre assessor-blind randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12 A total of 188 participants will be randomised into two groups the experimental group and the control group The control group participants will receive an upper body strength and fitness program conducted for 2-3 hours three times per week for 12 weeks while the experimental group articipants will receive a comprehensive full body exercise program conducted for 2-3 hours three times per week for 12 weeks
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury
Total study duration is 35 years including a 24 month recruitment period a 12-week treatment period followed by 6 month and 12 month from baseline follow up assessments
Participants will be assessed by a blinded assessor the assessor will not know which group the participants are in using standard physiotherapy neurophysiological fitness and functional tests psychological and quality of life questionnaires as well as tests of immune function and bone structure
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury
Total study duration is 35 years including a 24 month recruitment period a 12-week treatment period followed by 6 month and 12 month from baseline follow up assessments
Participants will be assessed by a blinded assessor the assessor will not know which group the participants are in using standard physiotherapy neurophysiological fitness and functional tests psychological and quality of life questionnaires as well as tests of immune function and bone structure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None