Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery
HipSPORT
The Effect of Education and Supervised Exercise vs. Education Alone on Time to Total Hip Replacement in Patients With Hip Osteoarthritis Considered Eligible for Surgery
1 other identifier
interventional
110
1 country
2
Brief Summary
The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis postpone time to hip replacement surgery following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 11, 2018
May 1, 2018
4.3 years
September 21, 2012
May 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Survival analysis (Kaplan-Maier survival curve)
Cumulative Survival analysis as time in days without surgery since inclusion
one year
Secondary Outcomes (3)
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
Baseline, 3 and 12 months
University of California Los Angeles activity score (UCLA)
Baseline, 3 and 12 months
Global perceived effect (GPE) score
3 and 12 months
Other Outcomes (8)
Self-reported exercise pain (VAS-scale)
3 months
Exercise adherence
3 months
Cost-effectiveness analysis
12 months
- +5 more other outcomes
Study Arms (2)
Supervised exercise and patient education
EXPERIMENTALThe entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).
Patient Education
OTHERThe patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration
Interventions
Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
Eligibility Criteria
You may qualify if:
- years and older
- Indication for total hip arthroplasty
- Residency within local municipal or willing to commute
You may not qualify if:
- Inflammatory joint disease
- Earlier ipsilateral proximal femur fracture
- Hip pain \< 3 months
- Neuropathy or neuromuscular disease
- Malignant disease
- Diseases where a moderate level of physical exercise is contraindicated
- Unable to speak or read Danish
- Unable to participate for other reasons
- Refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Odense University Hospitalcollaborator
- Institute for Clinical Research, Denmarkcollaborator
- Vejle Hospitalcollaborator
- Region of Southern Denmarkcollaborator
- The Danish Rheumatism Associationcollaborator
Study Sites (2)
Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark
Odense, 5200, Denmark
Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark
Vejle, 7100, Denmark
Related Publications (1)
Jensen C, Roos EM, Kjaersgaard-Andersen P, Overgaard S. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol. BMC Musculoskelet Disord. 2013 Jan 14;14:21. doi: 10.1186/1471-2474-14-21.
PMID: 23311889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carsten Jensen, PhD
Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 21, 2012
First Posted
October 2, 2012
Study Start
May 1, 2013
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
May 11, 2018
Record last verified: 2018-05