OsteoarthritisNCT00708734
Exercise Intervention to Reduce Postural Instability in Osteoarthritis
A study testing functional exercise training in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a one year pilot study evaluating the feasibility of a 10 week, twice weekly, group functional exercise sessions in individuals with knee osteoarthritis and its effect on gait and balance measures. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- functional exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 and older.
- Corrected vision not worse than 20/50.
- Ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility.
- Presence of knee OA based on clinical and radiological criteria.
Who cannot join
- Cognitive impairment with Mini Mental State Exam (MMSE) score <24; Scores at or below 24 indicate cognitive impairments, limiting ability to participate in the group and/or remember instructions.
- Metastatic cancer, since this limits ability to fully participate in the group and/or complete the intervention due to limited life expectancy and changing functional status.
- Central or peripheral neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease , peripheral neuropathy with or without foot drop, as determined by medical record review and physical exam; Severe Peripheral Vascular Disease with claudication or Spinal Stenosis with pseudoclaudication/chronic low back pain; These impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention.
- Lower extremity amputations, or foot deformities; Mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would be contraindicated (foot ulcers), since this would affect gait and balance measures.
- Use of medications known to impair balance, e.g. antipsychotics, benzodiazepines, anti-epileptics, etc. which would affect gait and balance measures.
- Severe arthritis limiting basic activities of daily living (ADL) and were offered or are pending joint replacement, since it is unlikely that any non-pharmacological intervention would be effective.
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- Total knee replacement on one or both sides, since gait and balance changes due to total knee replacement would confound the effect of interventions.
- Current involvement in physical therapy, since it would confound results.
- Medically unstable upon exam, i.e. poorly controlled blood pressure or blood sugar, unstable coronary artery disease, since group participation may compromise medical status.
- Morbid obesity (BMI>40) due to potential changes in gait variables (speed, cadence, stride length).
- Weight over 300 pounds (due to limitations of Neurocom force plate).
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital
Tampa, Florida, 33637-1022
About this study
This is a one year pilot study evaluating the feasibility of a 10 week, twice weekly, group functional exercise sessions in individuals with knee osteoarthritis and its effect on gait and balance measures.
Read the detailed description
Impaired gait and balance (referred to as impaired postural stability) is one of the most significant causes and consequences of falls. Persons with osteoarthritis (OA) of the knee represent one of the largest patient populations with impaired postural stability. Specifically, knee OA has been shown to reduce walking speed, shorten stride length and prolong the stance phase of the gait cycle. Patients with knee OA also have less range of motion of the hip, knee and ankle joints. Functional Exercise Training (FET) has been shown to improve gait and balance, and decrease falls and associated fall-related injuries in the general elderly populations. While traditional exercise programs have not been well-tolerated in persons with knee OA (due to pain), we are interested in whether a tailored FET intervention would be effective in this patient population. Immediate Objectives: O1: Characterize the etiology and mechanisms of postural instability in persons with knee OA; O2: Refine the clinical protocol for FET in veterans with knee OA; O3: Refine the sampling plan; O4: Refine the data collection protocol. This 1-year feasibility study uses a prospective cohort design, including data collection at baseline and three points post intervention (10 weeks {end of intervention}, 15 weeks, and 20 weeks). Subjects with knee osteoarthritis are enrolled. Inclusion Criteria: Age 60 and older; Corrected vision not worse than 20/50; Ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility; presence of knee OA based on clinical and radiological criteria. Sample size: 36 subjects. Intervention: Participants attend FET class twice weekly for 10 weeks. Our primary outcome is a composite measures of postural stability (gait and balance) and OA symptoms/physical disability. Secondary outcome measures include fall self-efficacy and quality of life. We also collect case histories on postural instability and falls as well as data on key mediating variables, including level of participation (dose of intervention), body mass index (BMI), analgesic use, tolerance of intervention, and number of joints affected by OA. Measurement tools: Balance is measured with Sensory Organization Test and Limits of Stability test using Neurocom Smart Balance Master and Berg Balance Test; Gait is measured with multiple kinetic and kinematic variables using VICON 3-D Motion Analysis System; OA symptoms/physical disability are measured using Western Ontario and McMaster University Arthritis Index (WOMAC) Osteoarthritis Index; Fall self-efficacy by Modified Fall Self Efficacy Scale; and Quality of life by Short Form 36v (SF-36v).
- Conditions
- Osteoarthritis
- Being tested
- functional exercise training
- Keywords
- exercise
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional exercise trainingBehavioural
twice weekly group sessions for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | functional exercise training Receives: Behavioral: functional exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait and Balance Measures
Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tatjana Bulat, MD, Principal investigator, James A. Haley Veterans' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708734
- Sponsor's protocol ID
- F5070-R
- Status last verified
- Oct 2014
- First submitted
- 27 Jun 2008
- Last updated
- 23 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention to Reduce Postural Instability in Osteoarthritis
- ClinicalTrials.gov ID
- NCT00708734
- Acronym / sponsor ID
- F5070-R
- Conditions
- Osteoarthritis
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Posted 23 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a one year pilot study evaluating the feasibility of a 10 week, twice weekly, group functional exercise sessions in individuals with knee osteoarthritis and its effect on gait and balance measures.
Detailed description
Impaired gait and balance (referred to as impaired postural stability) is one of the most significant causes and consequences of falls. Persons with osteoarthritis (OA) of the knee represent one of the largest patient populations with impaired postural stability. Specifically, knee OA has been shown to reduce walking speed, shorten stride length and prolong the stance phase of the gait cycle. Patients with knee OA also have less range of motion of the hip, knee and ankle joints. Functional Exercise Training (FET) has been shown to improve gait and balance, and decrease falls and associated fall-related injuries in the general elderly populations. While traditional exercise programs have not been well-tolerated in persons with knee OA (due to pain), we are interested in whether a tailored FET intervention would be effective in this patient population. Immediate Objectives: O1: Characterize the etiology and mechanisms of postural instability in persons with knee OA; O2: Refine the clinical protocol for FET in veterans with knee OA; O3: Refine the sampling plan; O4: Refine the data collection protocol. This 1-year feasibility study uses a prospective cohort design, including data collection at baseline and three points post intervention (10 weeks {end of intervention}, 15 weeks, and 20 weeks). Subjects with knee osteoarthritis are enrolled. Inclusion Criteria: Age 60 and older; Corrected vision not worse than 20/50; Ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility; presence of knee OA based on clinical and radiological criteria. Sample size: 36 subjects. Intervention: Participants attend FET class twice weekly for 10 weeks. Our primary outcome is a composite measures of postural stability (gait and balance) and OA symptoms/physical disability. Secondary outcome measures include fall self-efficacy and quality of life. We also collect case histories on postural instability and falls as well as data on key mediating variables, including level of participation (dose of intervention), body mass index (BMI), analgesic use, tolerance of intervention, and number of joints affected by OA. Measurement tools: Balance is measured with Sensory Organization Test and Limits of Stability test using Neurocom Smart Balance Master and Berg Balance Test; Gait is measured with multiple kinetic and kinematic variables using VICON 3-D Motion Analysis System; OA symptoms/physical disability are measured using Western Ontario and McMaster University Arthritis Index (WOMAC) Osteoarthritis Index; Fall self-efficacy by Modified Fall Self Efficacy Scale; and Quality of life by Short Form 36v (SF-36v).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: functional exercise trainingfunctional exercise training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50 and older.
- Corrected vision not worse than 20/50.
- Ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility.
- Presence of knee OA based on clinical and radiological criteria.
Key exclusion criteria (11 listed)
- Cognitive impairment with Mini Mental State Exam (MMSE) score <24; Scores at or below 24 indicate cognitive impairments, limiting ability to participate in the group and/or remember instructions.
- Metastatic cancer, since this limits ability to fully participate in the group and/or complete the intervention due to limited life expectancy and changing functional status.
- Central or peripheral neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease , peripheral neuropathy with or without foot drop, as determined by medical record review and physical exam; Severe Peripheral Vascular Disease with claudication or Spinal Stenosis with pseudoclaudication/chronic low back pain; These impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention.
- Lower extremity amputations, or foot deformities; Mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would be contraindicated (foot ulcers), since this would affect gait and balance measures.
- Use of medications known to impair balance, e.g. antipsychotics, benzodiazepines, anti-epileptics, etc. which would affect gait and balance measures.
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 |
|---|---|---|
| functional exercise trainingtwice weekly group sessions for 5 weeks | Behavioural | Arm 1 |
Primary outcome
Gait and Balance Measures
Time frame: 5 months
Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tatjana Bulat, MD principal investigator
James A. Haley Veterans' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional exercise training in people with Osteoarthritis, run by US Department of Veterans Affairs 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 4 inclusion and 11 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 23 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gait and Balance Measures (time frame: 5 months). 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 23 Oct 2014; AzTrials last refreshed its copy on 30 Oct 2026.