An interventional study of functional exercise training in Osteoarthritis, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-10-23.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
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.
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).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
functional exercise training
Behavioral: functional exercise training
twice weekly group sessions for 5 weeks
Gait and Balance Measures
Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.
Time frame: 5 months
| Milestone | Arm 1 |
|---|---|
| Started | 10 |
| Completed | 3 |
| Not completed | 7 |
| Withdrew: Scheduling conflict | 2 |
| Withdrew: Moved | 1 |
| Withdrew: Leg injury | 1 |
| Withdrew: Knee replacement | 1 |
| Withdrew: Vertigo | 1 |
| Withdrew: Leg fracture | 1 |
Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.
No measurements were reported for this outcome.
Collected over Date was collected from date of participant enrollment through the close of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Functional Exercise Training | — | 0/10 (0%) | 0/10 (0%) |
age over 50 and gender
| Age, Continuous(years) | Functional Exercise Training |
|---|---|
| Mean | 66.5 (50 to 77) |
| Sex: Female, Male(Participants) | Functional Exercise Training |
|---|---|
| Female | 1 |
| Male | 9 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs