Total Hip ArthroplastyNCT01817010
Strength and Function Following Total Hip Arthroplasty
A study testing Multi-Component Rehabilitation (CMC) in people with Total Hip Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation program (CMC) have better strength and functional performance compared to a control group (CON). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Multi-Component Rehabilitation (CMC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2015
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving a total hip replacement secondary to MD diagnosed end-state osteoarthritis only
- cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study.
Who cannot join
- HbA1c levels greater than 7% based on medical records
- neurological, vascular or cardiac problems that limit function
- moderate or severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity
- lower back pain which interferes with activities of daily living
- diagnosed disease which affects muscle function (Parkinson's, Fibromyalgia, Multiple Sclerosis)
- history of vestibular dysfunction
- body mass index greater than 40
- alcoholism or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation program (CMC) have better strength and functional performance compared to a control group (CON).
The investigators hypothesize that functional performance and strength in the muscles surrounding the hip and the knee will be greater in the multi-component rehabilitation group compared to the control group.
Read the detailed description
The participants will be enrolled and following surgery, randomized into one of two treatment groups (CMC or CON). Prior to randomization, both groups will participate in two weeks of home rehabilitation consisting mobility training and activities of daily living. After randomization, the CMC group will receive physical therapy 2x/ week for 8 weeks from a licensed physical therapist and member of the investigative team starting 2 weeks after Total Hip Arthroplasty (THA). The CON group will continue activities provided by their home rehabilitation therapist for 8 weeks. The CON group will then participate in the CMC intervention beginning 10 weeks after THA. These patients will complete pre-operative and post-operative testing as described above.
The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same multi-component rehabilitation intervention beginning 10 weeks after THA.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Multi-Component Rehabilitation (CMC), Control (CON)
- Keywords
- Total Hip Arthroplasty, Muscle Strength, Hip Osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Component Rehabilitation (CMC)Behavioural
Control (CON)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Multi-Component Rehabilitation (CMC) | Experimental | The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. Receives: Behavioral: Multi-Component Rehabilitation (CMC) |
| Control (CON) | Active comparator | The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same CMC rehabilitation intervention beginning 10 weeks after THA. Receives: Behavioral: Control (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stair Climbing Time
Time to ascend and descend 12 stairs.
Measured: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Secondary outcomes (2)
Functional Performance Tests
Health status and activity questionnaires (SF-36, WOMAC, UCLA score), timed up and go test, sit to stand performance, 6 minute walk test, timed Single Leg balance on variable surfaces, Fullerton Assessment of Balance and the modified Trendelenburg test
Measured: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Isometric Muscle Strength
Isometric strength of the hip flexors, extensors, abductors and knee extensors and flexors.
Measured: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, PT,PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817010
- Sponsor's protocol ID
- 09-1121
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2013
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Function Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01817010
- Acronym / sponsor ID
- 09-1121
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Muscle Strength, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Mar 2013 (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.
To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation program (CMC) have better strength and functional performance compared to a control group (CON).
The investigators hypothesize that functional performance and strength in the muscles surrounding the hip and the knee will be greater in the multi-component rehabilitation group compared to the control group.
Detailed description
The participants will be enrolled and following surgery, randomized into one of two treatment groups (CMC or CON). Prior to randomization, both groups will participate in two weeks of home rehabilitation consisting mobility training and activities of daily living. After randomization, the CMC group will receive physical therapy 2x/ week for 8 weeks from a licensed physical therapist and member of the investigative team starting 2 weeks after Total Hip Arthroplasty (THA). The CON group will continue activities provided by their home rehabilitation therapist for 8 weeks. The CON group will then participate in the CMC intervention beginning 10 weeks after THA. These patients will complete pre-operative and post-operative testing as described above.
The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same multi-component rehabilitation intervention beginning 10 weeks after THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Component Rehabilitation (CMC) | Experimental | Behavioral: Multi-Component Rehabilitation (CMC)The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. |
| Control (CON) | Active comparator | Behavioral: Control (CON)The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same CMC rehabilitation intervention beginning 10 weeks after THA. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- receiving a total hip replacement secondary to MD diagnosed end-state osteoarthritis only
- cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study.
Key exclusion criteria (8 listed)
- HbA1c levels greater than 7% based on medical records
- neurological, vascular or cardiac problems that limit function
- moderate or severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity
- lower back pain which interferes with activities of daily living
- diagnosed disease which affects muscle function (Parkinson's, Fibromyalgia, Multiple Sclerosis)
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 |
|---|---|---|
| Multi-Component Rehabilitation (CMC) | Behavioural | Multi-Component Rehabilitation (CMC) |
| Control (CON) | Behavioural | Control (CON) |
Primary outcome
Stair Climbing Time
Time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Time to ascend and descend 12 stairs.
2 secondary outcomes
Functional Performance Tests
Time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Isometric Muscle Strength
Time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
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 Jul 2016.
Related trials for Total Hip Arthroplasty
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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.
Jennifer Stevens-Lapsley, PT,PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Component Rehabilitation (CMC) in people with Total Hip Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 8 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 Jul 2016. 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 United States. 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?
Stair Climbing Time (time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2016.