Hip and Knee Joint OsteoarthritisNCT01555307
Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty
A study testing Typical range of motion and muscle strengthening exercises, and balance exercises and Typical group in people with Hip and Knee Joint Osteoarthritis and Hip and Knee Joint Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip and Knee Joint Osteoarthritis, Hip and Knee Joint Arthroplasty
- What is being tested?
- Typical range of motion and muscle strengthening exercises, and balance exercises and Typical group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Apr 2010
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary unilateral total hip or knee joint arthroplasty.
- Patients who had been advised to weight bear as tolerated following surgery.
Who cannot join
- Patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg.
- Patients with neurological conditions such as hemiplegia, peripheral neuropathy, Parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Physical Therapy, University of Western Ontario
London, Ontario, N6A 5C1
About this study
The purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty
Read the detailed description
Rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises. Although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate. However, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.
- Being tested
- Typical range of motion and muscle strengthening exercises, and balance exercises, Typical group
- Keywords
- total hip arthroplasty, total knee arthroplasty, balance exercises, force plate, berg balance scale, timed up and go test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typical range of motion and muscle strengthening exercises, and balance exercisesOther
Seven typical exercises, and three balance exercises, 10 times each, 3 times a day.
Typical groupOther
Seven typical exercises, 10 times each, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Balance group | Experimental | Typical plus balance exercises Receives: Other: Typical range of motion and muscle strengthening exercises, and balance exercises |
| Typical group | Other | Typical exercises Receives: Other: Typical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
Measured: Day 0 and Week 5
Secondary outcomes (4)
Timed Up and go test
Measured: Day 0 and Week 5
Western Ontario McMaster Universities Osteoarthritis Index
Measured: Day 0 and Week 5
Activity-specific Balance Confidence Scale
Measured: Day 0 and Week 5
Force platform
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJun 2007
- Primary completionMay 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee Joint OsteoarthritisStudies of the same condition, open and under way.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Investigators
- John Kramer, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555307
- Sponsor's protocol ID
- R-06-461
- Other IDs
- 12697E
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01555307
- Acronym / sponsor ID
- R-06-461
- Keywords
- total hip arthroplasty, total knee arthroplasty, balance exercises, force plate, berg balance scale, timed up and go test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Mar 2012 (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 purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty
Detailed description
Rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises. Although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate. However, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance group | Experimental | Other: Typical range of motion and muscle strengthening exercises, and balance exercisesTypical plus balance exercises |
| Typical group | Other | Other: Typical groupTypical exercises |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary unilateral total hip or knee joint arthroplasty.
- Patients who had been advised to weight bear as tolerated following surgery.
Key exclusion criteria (2 listed)
- Patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg.
- Patients with neurological conditions such as hemiplegia, peripheral neuropathy, Parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.
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 |
|---|---|---|
| Typical range of motion and muscle strengthening exercises, and balance exercisesSeven typical exercises, and three balance exercises, 10 times each, 3 times a day. | Other | Balance group |
| Typical groupSeven typical exercises, 10 times each, 3 times a day | Other | Typical group |
Primary outcome
Berg balance scale
Time frame: Day 0 and Week 5
4 secondary outcomes
Timed Up and go test
Time frame: Day 0 and Week 5
Western Ontario McMaster Universities Osteoarthritis Index
Time frame: Day 0 and Week 5
Activity-specific Balance Confidence Scale
Time frame: Day 0 and Week 5
Force platform
Time frame: Week 5
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 15 Mar 2012.
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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.
John Kramer, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Typical range of motion and muscle strengthening exercises, and balance exercises and Typical group in people with Hip and Knee Joint Osteoarthritis and Hip and Knee Joint Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 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 15 Mar 2012. 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 Canada. 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?
Berg balance scale (time frame: Day 0 and Week 5). 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 15 Mar 2012.