Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462937
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-13
Brief Title:
A Digital Exercise Intervention in Patients With Spondyloarthritis
Sponsor:
Diakonhjemmet Hospital
Organization:
Diakonhjemmet Hospital
Study Overview
Official Title:
The SPARK Trial a Digital Exercise Intervention in Patients With Spondyloarthritis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SPARK
Brief Summary:
This protocol describes a 6-month randomised controlled exercise trial in patients with axial spondyloarthritis axSpA with re-randomization after 3-months The primary outcome of the trial disease activity will be evaluated at 3-months The exercise programme on trial comprises high intensity interval training HIIT muscular strength exercise and aerobic physical activity sessions of specified duration frequency and intensity It also includes brief knowledge videos to empower the patient The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity The SPARK application is built on a platform delivered by ABEL Technologies trademark and is customised for patients with axSpA
Detailed Description:
Main objectives To assess if a digital personally tailored exercise program with remote follow-up can reduce disease activity measured by ankylosing spondylitis disease activity score ASDAS in patients with recently diagnosed axial spondyloarthritis axSpA
Main inclusion criteria Adults 18 years with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score ASAS classification criteria who are biologic disease modifying anti-rheumatic drugs bDMARD naïve and have an active disease ASDAS 13
Main exclusion criteria
Active iridocyclitis c-reactive protein CRP 30 contraindication to high intensity interval training
Primary outcome Proportion of participants in ASDAS inactive ASDAS 13 at 3 months
Number of participants 260 with an anticipated drop-out rate of 15
Study design A two-arm multi-centre clinical trial randomization 11 to either digital exercise intervention with remote follow-up or usual care
Intervention Exercise delivered through an application and with personalised follow-up by a coach through remote sessions the participant and SPARK-coach are not at the same physical location weekly The exercise is progressively tailored to the fitness level of each participant The program consists of 5 session per week on 3 different days including two sessions with HIIT 2 sessions with strength exercise and one session with an aerobic exercise at moderate intensity Goal for HIIT is 10 minutes two times per week at 85-95 of maximal heart rate 20 minutes in total The exercise will be performed at a location of the participants choice and data will be logged by a sports watch
Efficacy assessments ASDAS disease activity measure 4 patient reported questions and measure of CRP Bath ankylosing spondylitis disease activity index BASDAI
Physical measure cardiorespiratory fitness in a subset of participants direct cardiopulmonary testing muscular strength tests
Psychological measures Warwick and Edinburgh mental wellbeing scale WEMWBS EuroQol EQ5D
Medication use of bDMARDs use of NSAID
Safety assessments General physical examination and vital signs laboratory tests as a part of usual clinical care record of adverse events and serious adverse events magnetic resonance imaging MRI
Main inclusion criteria Adults 18 years with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score ASAS classification criteria who are biologic disease modifying anti-rheumatic drugs bDMARD naïve and have an active disease ASDAS 13
Main exclusion criteria
Active iridocyclitis c-reactive protein CRP 30 contraindication to high intensity interval training
Primary outcome Proportion of participants in ASDAS inactive ASDAS 13 at 3 months
Number of participants 260 with an anticipated drop-out rate of 15
Study design A two-arm multi-centre clinical trial randomization 11 to either digital exercise intervention with remote follow-up or usual care
Intervention Exercise delivered through an application and with personalised follow-up by a coach through remote sessions the participant and SPARK-coach are not at the same physical location weekly The exercise is progressively tailored to the fitness level of each participant The program consists of 5 session per week on 3 different days including two sessions with HIIT 2 sessions with strength exercise and one session with an aerobic exercise at moderate intensity Goal for HIIT is 10 minutes two times per week at 85-95 of maximal heart rate 20 minutes in total The exercise will be performed at a location of the participants choice and data will be logged by a sports watch
Efficacy assessments ASDAS disease activity measure 4 patient reported questions and measure of CRP Bath ankylosing spondylitis disease activity index BASDAI
Physical measure cardiorespiratory fitness in a subset of participants direct cardiopulmonary testing muscular strength tests
Psychological measures Warwick and Edinburgh mental wellbeing scale WEMWBS EuroQol EQ5D
Medication use of bDMARDs use of NSAID
Safety assessments General physical examination and vital signs laboratory tests as a part of usual clinical care record of adverse events and serious adverse events magnetic resonance imaging MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None