- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638417
Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
The aim of the study is to improve hospital treatment and rehabilitation of patients with hip arthroplasty to help the patients to regain functional ability in the shortest possible time, and reduce hospital and rehabilitation time to save costs for the patient and society.
Optimal reconstruction of the hip joint and the effect of an intensive physical training programme are compared to conventional rehabilitation programmes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway, 7489
- Faculty of Medicine, NTNU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary osteoarthritis
- Unilateral osteoarthritis
- Age below 65 yrs
- ASA group 1-2
Exclusion Criteria:
- Pregnancy
- Age below 18 yrs
- Cardiovascular disease
- Diseases in the musculoskeletal system that could influence on training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: maximal strength training
maximal dynamic strength training
|
maximal dynamic strength training from 1 week after the operation, 5 training bouts a week for 4 weeks.
The regimen consisted of 2 exercises, leg press and hip abduction, that included 4 series of 5RM involving the operated leg only.
5RM corresponds to approximately 85% of 1RM.
When the patients managed to perform 6RM, the load was increased by 5kg.
The series were separated by resting periods of 2 minutes.
conventional rehabilitation program: inpatient treatment in a rehabilitation center.
Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed.
Each session lasted 1 hour and was performed 5 days a week for 4 weeks.
|
|
Other: conventional rehabilitation
rehabilitation as usual
|
conventional rehabilitation program: inpatient treatment in a rehabilitation center.
Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed.
Each session lasted 1 hour and was performed 5 days a week for 4 weeks.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jan Hoff, prof, Norwegian University of Science and Technology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4.2005.1527a
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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