OsteoarthritisHipSPORTNCT01697241
Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery
A study testing Supervised exercise and Patient education in people with Osteoarthritis, run by University of Southern Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Supervised exercise and Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years and older
- Indication for total hip arthroplasty
- Residency within local municipal or willing to commute
Who cannot join
- 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
Show all 9Show fewer
- Unable to speak or read Danish
- Unable to participate for other reasons
- Refuse to participate
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark
Odense, 5200
Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark
Vejle, 7100
About this study
Official title: 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
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.
Read the detailed description
Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown
- Conditions
- Osteoarthritis
- Being tested
- Supervised exercise, Patient education
- Keywords
- Exercise Therapy, Education, Osteoarthritis, Hip, Hip replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseOther
Also called NEMEX-TJR and RT
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
Patient educationOther
Also called BOA
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise and patient education | Experimental | The 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). Receives: Other: Supervised exercise; Other: Patient education |
| Patient Education | Other | The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Survival analysis (Kaplan-Maier survival curve)
Cumulative Survival analysis as time in days without surgery since inclusion
Measured: one year
Secondary outcomes (3)
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu).
Measured: Baseline, 3 and 12 months
University of California Los Angeles activity score (UCLA)
Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations
Measured: Baseline, 3 and 12 months
Global perceived effect (GPE) score
Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMay 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Institute for Clinical Research, Denmark, Vejle Hospital, Region of Southern Denmark, The Danish Rheumatism Association
- Responsible party
- Principal investigator, Carsten Jensen, University of Southern Denmark
- Investigators
- Carsten Jensen, PhD, Principal investigator, Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697241
- Sponsor's protocol ID
- S-20120109
- Acronym
- HipSPORT
- Status last verified
- May 2018
- First submitted
- 21 Sep 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23311889
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01697241
- Acronym / sponsor ID
- HipSPORT / S-20120109
- Conditions
- Osteoarthritis
- Keywords
- Exercise Therapy, Education, Osteoarthritis, Hip, Hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Institute for Clinical Research, Denmark, Vejle Hospital, Region of Southern Denmark, The Danish Rheumatism Association
- Study start
- May 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise and patient education | Experimental | Other: Supervised exercise, Other: Patient educationThe 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 | Other | Other: Patient educationThe patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years and older
- Indication for total hip arthroplasty
- Residency within local municipal or willing to commute
Key exclusion criteria (9 listed)
- Inflammatory joint disease
- Earlier ipsilateral proximal femur fracture
- Hip pain < 3 months
- Neuropathy or neuromuscular disease
- Malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseAlso: NEMEX-TJR and RTPatients 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 | Other | Supervised exercise and patient education |
| Patient educationAlso: BOAThe patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration | Other | Patient Education, Supervised exercise and patient education |
Primary outcome
Cumulative Survival analysis (Kaplan-Maier survival curve)
Time frame: one year
Cumulative Survival analysis as time in days without surgery since inclusion
3 secondary outcomes
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
Time frame: Baseline, 3 and 12 months
University of California Los Angeles activity score (UCLA)
Time frame: Baseline, 3 and 12 months
Global perceived effect (GPE) score
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 23311889Jensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Jensen, PhD principal investigator
Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise and Patient education in people with Osteoarthritis, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Survival analysis (Kaplan-Maier survival curve) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.