Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391554
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-22
Brief Title:
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-03
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:
EDUEX
Brief Summary:
The EDUEX trial will determine whether the addition of progressive resistance training PRT to a patient education program EDU will improve clinical outcomes in patients with hip OA
In a subsample the effect of PRT on the articular cartilage and other structures of the hip joint is investigated In this subsample a comprehensive assessment of possible mechanisms underlying the effects of exercise on pain and function is undertaken
The EduEx trial will be a multicentre stratified by site block randomized allocation 11 controlled parallel-group superiority trial 150 people with hip OA will be recruited from hospitals physiotherapy clinics social media and newspapers Participants will be randomized to PRT and EDU or EDU alone All 150 participants will be included in the clinical evaluation study CLIN The last 40 participants randomized to PRTEDU and to EDU respectively will also be included in the mechanistic MECH evaluation study n80 by being asked to participate in additional outcome assessments The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study while a secondary endpoint will be the 3-month follow-up
In a subsample the effect of PRT on the articular cartilage and other structures of the hip joint is investigated In this subsample a comprehensive assessment of possible mechanisms underlying the effects of exercise on pain and function is undertaken
The EduEx trial will be a multicentre stratified by site block randomized allocation 11 controlled parallel-group superiority trial 150 people with hip OA will be recruited from hospitals physiotherapy clinics social media and newspapers Participants will be randomized to PRT and EDU or EDU alone All 150 participants will be included in the clinical evaluation study CLIN The last 40 participants randomized to PRTEDU and to EDU respectively will also be included in the mechanistic MECH evaluation study n80 by being asked to participate in additional outcome assessments The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study while a secondary endpoint will be the 3-month follow-up
Detailed Description:
DESIGN
The EduEx trial will be a multicentre stratified by site block randomized allocation 11 controlled parallel-group superiority trial 150 people with hip OA will be recruited from the Orthopedic Departments at hospitals and from physiotherapy clinics social media and newspapers Participants will be randomized to PRTEDU or EDU
All 150 participants will be included in the clinical evaluation study CLIN while only the last 40 participants randomized to PRTEDU and EDU respectively will also be included in the mechanistic evaluation study MECH n80 by being asked to participate in additional outcome assessments including magnetic resonance imaging of the hip
The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study while the secondary endpoint will be the 3-month follow-up
RANDOMIZATION
After baseline assessment participants will be randomized in a 11 ratio to PRTEDU or EDU A computer-generated list of random numbers will be generated in the Research Electronic Data Capture REDCap system The randomization will be stratified by site and block randomized to ensure equal distribution of allocations among trial sites Two lists of random numbers will be generated one for the first 70 participants and one for the last 80 participants recruited to enable an even distribution of treatment allocation of the 80 participants in the MECH subsample Treatment allocation will be concealed as one of the principal investigators will use the randomization tool only after the baseline assessment has been performed
INTERVENTIONS
The PRT and EDU interventions will be conducted either at the collaborating hospital departments or physiotherapy clinics across Denmark
PRT Participants allocated to receive PRT will attend 3 months of supervised PRT followed by 9 months of unsupervised PRT with the addition of 8 exercise booster sessions The PRT program consists of two weekly training sessions 60 min per session with 48 hours of rest between sessions All supervised PRT sessions will be group-based up to 5 participants supervised by one physiotherapist
EDU Both treatment arms will attend three EDU sessions provided by a trained physiotherapist involving important disease-specific information The sessions will address knowledge of OA treatment options with a specific focus on physical activity recommendations advice on self-management and more All three sessions will emphasize on engaging the participants actively and sharing experiences with each other
STATISTICAL ANALYSIS PLAN
The analyses will be based on the between-group difference in change in the primary and secondary outcomes from baseline to the 12 months follow-up according to the intention-to-treat ITT principle Additionally per protocol analyses will be performed including only participants with high adherence to the EDU sessions at least 2 sessions attended and high adherence to the exercise sessions 80 of the planned sessions completed and high exercise fidelity 80 of prescribed repetitions performed Between-group comparisons of change from baseline to follow-up in the primary and secondary continuous outcomes will be analysed using a repeated measures mixed model with participants and sites as random effects and with visits and treatment arm as fixed effects
DATA MANAGEMENT
All data and outcomes collected from participants will be entered into the REDCap database For the patient reported outcomes participants will fill out questionnaires directly into REDCap If a participant is unable to do so they will fill out paper versions of the questionnaires and the tester will enter it into REDCap and shred the paper versions The data will be maintained in storage for five years after trial termination
PATIENT AND PUBLIC INVOLVEMENT
In the EduEx trial we have established an advisory board of four patients with hip osteoarthritis and a physiotherapists Patients and physiotherapists have been invited to participate in the board throughout the research project The board have and will continue to influence clinical outcomes practicalities and content of the interventions The board will have one meeting every three months during the planning conducting and dissemination processes of the trial and will give advice consultation level of involvement throughout
ETHICAL CONSIDERATIONS
The study intervention is non-invasive and is expected to result in a generally optimized health status of the included participants Approval from the Central Denmark Region Committee on Health Research has been obtained for the EduEx trial Written informed consent will be obtained from all participants prior to inclusion and the project will be performed in accordance with the Helsinki Declaration Authorship eligibility will be based on the recommendations from The International Committee of Medical Journal Editors Any important protocol amendments for The EduEx trial will be registered at ClinicalTrialgov and reported to the Central Denmark Region Committee on Health Research
RESEARCH RESULTS
The results from this trial will be published in peer-reviewed scientific journals and presented at congresses regardless of whether the results are inconclusive negative or positive
There are 3 preplanned studies to be conducted on the results from this trial that will be reported in 3 separate research papers
1 The primary clinical evaluation study CLIN comparing effects of PRTEDU and EDU alone on the primary outcome of HOOS ADL is study number one
2 The primary mechanistic evaluation study MECH comparing PRTEDU and EDU alone on changes in hip joint tissue is study number two
3 A secondary MECH evaluation study MECH2 is study number three in which the mechanisms of exercise are investigated by looking at associations of changes in other outcomes with the changes seen for hip pain and physical function
The EduEx trial will be a multicentre stratified by site block randomized allocation 11 controlled parallel-group superiority trial 150 people with hip OA will be recruited from the Orthopedic Departments at hospitals and from physiotherapy clinics social media and newspapers Participants will be randomized to PRTEDU or EDU
All 150 participants will be included in the clinical evaluation study CLIN while only the last 40 participants randomized to PRTEDU and EDU respectively will also be included in the mechanistic evaluation study MECH n80 by being asked to participate in additional outcome assessments including magnetic resonance imaging of the hip
The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study while the secondary endpoint will be the 3-month follow-up
RANDOMIZATION
After baseline assessment participants will be randomized in a 11 ratio to PRTEDU or EDU A computer-generated list of random numbers will be generated in the Research Electronic Data Capture REDCap system The randomization will be stratified by site and block randomized to ensure equal distribution of allocations among trial sites Two lists of random numbers will be generated one for the first 70 participants and one for the last 80 participants recruited to enable an even distribution of treatment allocation of the 80 participants in the MECH subsample Treatment allocation will be concealed as one of the principal investigators will use the randomization tool only after the baseline assessment has been performed
INTERVENTIONS
The PRT and EDU interventions will be conducted either at the collaborating hospital departments or physiotherapy clinics across Denmark
PRT Participants allocated to receive PRT will attend 3 months of supervised PRT followed by 9 months of unsupervised PRT with the addition of 8 exercise booster sessions The PRT program consists of two weekly training sessions 60 min per session with 48 hours of rest between sessions All supervised PRT sessions will be group-based up to 5 participants supervised by one physiotherapist
EDU Both treatment arms will attend three EDU sessions provided by a trained physiotherapist involving important disease-specific information The sessions will address knowledge of OA treatment options with a specific focus on physical activity recommendations advice on self-management and more All three sessions will emphasize on engaging the participants actively and sharing experiences with each other
STATISTICAL ANALYSIS PLAN
The analyses will be based on the between-group difference in change in the primary and secondary outcomes from baseline to the 12 months follow-up according to the intention-to-treat ITT principle Additionally per protocol analyses will be performed including only participants with high adherence to the EDU sessions at least 2 sessions attended and high adherence to the exercise sessions 80 of the planned sessions completed and high exercise fidelity 80 of prescribed repetitions performed Between-group comparisons of change from baseline to follow-up in the primary and secondary continuous outcomes will be analysed using a repeated measures mixed model with participants and sites as random effects and with visits and treatment arm as fixed effects
DATA MANAGEMENT
All data and outcomes collected from participants will be entered into the REDCap database For the patient reported outcomes participants will fill out questionnaires directly into REDCap If a participant is unable to do so they will fill out paper versions of the questionnaires and the tester will enter it into REDCap and shred the paper versions The data will be maintained in storage for five years after trial termination
PATIENT AND PUBLIC INVOLVEMENT
In the EduEx trial we have established an advisory board of four patients with hip osteoarthritis and a physiotherapists Patients and physiotherapists have been invited to participate in the board throughout the research project The board have and will continue to influence clinical outcomes practicalities and content of the interventions The board will have one meeting every three months during the planning conducting and dissemination processes of the trial and will give advice consultation level of involvement throughout
ETHICAL CONSIDERATIONS
The study intervention is non-invasive and is expected to result in a generally optimized health status of the included participants Approval from the Central Denmark Region Committee on Health Research has been obtained for the EduEx trial Written informed consent will be obtained from all participants prior to inclusion and the project will be performed in accordance with the Helsinki Declaration Authorship eligibility will be based on the recommendations from The International Committee of Medical Journal Editors Any important protocol amendments for The EduEx trial will be registered at ClinicalTrialgov and reported to the Central Denmark Region Committee on Health Research
RESEARCH RESULTS
The results from this trial will be published in peer-reviewed scientific journals and presented at congresses regardless of whether the results are inconclusive negative or positive
There are 3 preplanned studies to be conducted on the results from this trial that will be reported in 3 separate research papers
1 The primary clinical evaluation study CLIN comparing effects of PRTEDU and EDU alone on the primary outcome of HOOS ADL is study number one
2 The primary mechanistic evaluation study MECH comparing PRTEDU and EDU alone on changes in hip joint tissue is study number two
3 A secondary MECH evaluation study MECH2 is study number three in which the mechanisms of exercise are investigated by looking at associations of changes in other outcomes with the changes seen for hip pain and physical function
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