Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery

NCT ID: NCT01697241

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Supervised exercise and patient education

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).

Group Type EXPERIMENTAL

Supervised exercise

Intervention Type OTHER

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 education

Intervention Type OTHER

The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration

Patient Education

The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration

Group Type OTHER

Patient education

Intervention Type OTHER

The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration

Interventions

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Supervised exercise

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

Intervention Type OTHER

Patient education

The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration

Intervention Type OTHER

Other Intervention Names

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NEMEX-TJR and RT BOA

Eligibility Criteria

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Inclusion Criteria

* 40 years and older
* Indication for total hip arthroplasty
* Residency within local municipal or willing to commute

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Institute for Clinical Research, Denmark

INDUSTRY

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Carsten Jensen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carsten Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark

Locations

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Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark

Odense, , Denmark

Site Status

Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark

Vejle, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23311889 (View on PubMed)

Other Identifiers

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S-20120109

Identifier Type: -

Identifier Source: org_study_id

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