Muscle WeaknessNCT02498093
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty
A study testing Maximal strength training and conventional rehabilitation in people with Muscle Weakness, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Muscle Weakness
- 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
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2015to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled for total hip arthroplasty (THA)
- living nearby Trondheim
- diagnosis of primary osteoarthritis as the main cause for elective THA
- ASA score of I-III (stable)
Who cannot join
- muscular or skeletal disease which might influence the training and/or physical testing performance
- communication difficulties
- postoperatively discharged to a rehabilitation institution
- THA in the bilateral hip that is not fully rehabilitated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training
Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.
- Conditions
- Muscle Weakness
- Being tested
- Maximal strength training, conventional rehabilitation
- Keywords
- Resistance training, Arthroplasty, Replacement, Hip, Professional-Patient Relations, Evidence-based practice
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength trainingBehavioural
conventional rehabilitationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Maximal strength training | Experimental | Maximal strength training supervised by a physiotherapist Receives: Behavioral: Maximal strength training |
| Control | Active comparator | Conventional rehabilitation supervised by a physiotherapist Receives: Behavioral: conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
leg press (kg), abduction (kg)
Measured: 3 months
Muscular strength
leg press (kg), abduction (kg)
Measured: 6 months
muscular strength
leg press (kg), abduction (kg)
Measured: 1 year
Secondary outcomes (2)
Physical function
Harris hip score, 6 min walking test
Measured: up to 1 year
Bone mineral density
Dual X-ray absorptiometry (DXA)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Jacob Stovner, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498093
- Sponsor's protocol ID
- 2010/3373
- Status last verified
- Apr 2020
- First submitted
- 8 Jul 2015
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
PubMed 32301372Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. A randomized controlled trial on maximal strength training in 60 patients undergoing total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):295-301. doi: 10.1080/17453674.2018.1441362. Epub 2018 Mar 1.
PubMed 29493347
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training
- ClinicalTrials.gov ID
- NCT02498093
- Acronym / sponsor ID
- 2010/3373
- Conditions
- Muscle Weakness
- Keywords
- Resistance training, Arthroplasty, Replacement, Hip, Professional-Patient Relations, Evidence-based practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Jul 2015 (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.
Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal strength training | Experimental | Behavioral: Maximal strength trainingMaximal strength training supervised by a physiotherapist |
| Control | Active comparator | Behavioral: conventional rehabilitationConventional rehabilitation supervised by a physiotherapist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for total hip arthroplasty (THA)
- living nearby Trondheim
- diagnosis of primary osteoarthritis as the main cause for elective THA
- ASA score of I-III (stable)
Key exclusion criteria (4 listed)
- muscular or skeletal disease which might influence the training and/or physical testing performance
- communication difficulties
- postoperatively discharged to a rehabilitation institution
- THA in the bilateral hip that is not fully rehabilitated.
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 training | Behavioural | Maximal strength training |
| conventional rehabilitation | Behavioural | Control |
Primary outcome
Muscular strength
Time frame: 3 months
leg press (kg), abduction (kg)
Muscular strength
Time frame: 6 months
leg press (kg), abduction (kg)
muscular strength
Time frame: 1 year
leg press (kg), abduction (kg)
2 secondary outcomes
Physical function
Time frame: up to 1 year
Bone mineral density
Time frame: up to 1 year
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 22 Apr 2020.
- Results publication: PubMed 32301372Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
- Results publication: PubMed 29493347Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. A randomized controlled trial on maximal strength training in 60 patients undergoing total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):295-301. doi: 10.1080/17453674.2018.1441362. Epub 2018 Mar 1.
- Individual participant dataSharing planned: Undecided
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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.
Lars Jacob Stovner, prof study director
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 Muscle Weakness, 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 22 Apr 2020. 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.
What does the primary outcome measure?
Muscular strength (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT02498093, which also lists 2 linked publications.
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 22 Apr 2020.