Osteoarthritis, HipNCT00638417
Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
A study testing Maximal strength training and conventional rehabilitation in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Maximal strength training and conventional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Nov 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis
- Unilateral osteoarthritis
- Age below 65 yrs
- ASA group 1-2
Who cannot join
- Pregnancy
- Age below 18 yrs
- Cardiovascular disease
- Diseases in the musculoskeletal system that could influence on training
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Maximal strength training, conventional rehabilitation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength trainingBehavioural
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 rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| maximal strength training | Experimental | maximal dynamic strength training Receives: Behavioral: Maximal strength training; Behavioral: conventional rehabilitation |
| conventional rehabilitation | Other | rehabilitation as usual Receives: Behavioral: conventional rehabilitation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionNov 2007
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 Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)
- Responsible party
- Sponsor
- Investigators
- Jan Hoff, prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638417
- Sponsor's protocol ID
- 4.2005.1527a
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2008
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Husby VS, Helgerud J, Bjorgen S, Husby OS, Benum P, Hoff J. Early maximal strength training is an efficient treatment for patients operated with total hip arthroplasty. Arch Phys Med Rehabil. 2009 Oct;90(10):1658-67. doi: 10.1016/j.apmr.2009.04.018.
PubMed 19801053
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
- ClinicalTrials.gov ID
- NCT00638417
- Acronym / sponsor ID
- 4.2005.1527a
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)
- Study start
- Jan 2006 (actual)
- Primary completion
- Mar 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Mar 2008 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maximal strength training | Experimental | Behavioral: Maximal strength training, Behavioral: conventional rehabilitationmaximal dynamic strength training |
| conventional rehabilitation | Other | Behavioral: conventional rehabilitationrehabilitation as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary osteoarthritis
- Unilateral osteoarthritis
- Age below 65 yrs
- ASA group 1-2
Key exclusion criteria (4 listed)
- Pregnancy
- Age below 18 yrs
- Cardiovascular disease
- Diseases in the musculoskeletal system that could influence on training
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 |
|---|---|---|
| Maximal strength trainingmaximal 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. | Behavioural | maximal strength training |
| conventional rehabilitationconventional 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. | Behavioural | conventional rehabilitation, maximal strength training |
Primary outcome
Not reported in the source record.
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 12 Mar 2018.
- Results publication: PubMed 19801053Husby VS, Helgerud J, Bjorgen S, Husby OS, Benum P, Hoff J. Early maximal strength training is an efficient treatment for patients operated with total hip arthroplasty. Arch Phys Med Rehabil. 2009 Oct;90(10):1658-67. doi: 10.1016/j.apmr.2009.04.018.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Jan Hoff, prof principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal strength training and conventional rehabilitation in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 4 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638417, 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 12 Mar 2018.