Knee OsteoarthritisNCT00583245
Improving Walking in Older Adults With Knee Osteoarthritis
A study testing Gait Training in people with Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
- Age 60 or older
Who cannot join
- acute or terminal illness
- unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months.
- Bilateral knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Mobility in Older Adults With Knee Osteoarthritis
Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. Based on this principle, the specific aim of this pilot study is to design a patient-specific gait training intervention using analysis of compensatory joint moments and energy expenditure. Successful completion will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.
- Conditions
- Knee Osteoarthritis
- Being tested
- Gait Training
- Keywords
- Osteoarthritis, Gait training, Knee pain, Rehabilitation, Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrainingOther
Gait training with physical therapist 2/week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gait training Receives: Other: Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire
Measured: 12 weeks
Changes in the disability measure, a timed 400 meter walk
Measured: 12 Weeks
Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Neil A Segal, University of Iowa
- Investigators
- Neil Segal, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583245
- Sponsor's protocol ID
- 200704794
- Other IDs
- 1K23AG030945-01
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2007
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mobility in Older Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00583245
- Acronym / sponsor ID
- 200704794
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Gait training, Knee pain, Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Dec 2007 (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.
Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. Based on this principle, the specific aim of this pilot study is to design a patient-specific gait training intervention using analysis of compensatory joint moments and energy expenditure. Successful completion will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Gait TrainingGait training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
- Age 60 or older
Key exclusion criteria (3 listed)
- acute or terminal illness
- unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months.
- Bilateral knee replacement
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 |
|---|---|---|
| Gait TrainingGait training with physical therapist 2/week for 3 months | Other | 1 |
Primary outcome
Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire
Time frame: 12 weeks
Changes in the disability measure, a timed 400 meter walk
Time frame: 12 Weeks
Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire
Time frame: 12 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 10 Mar 2017.
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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.
Neil Segal, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training in people with Knee Osteoarthritis, run by University of Iowa 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 3 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 10 Mar 2017. 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?
Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire (time frame: 12 weeks). 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?
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 10 Mar 2017.