Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-28 @ 8:19 PM
Study NCT ID:
NCT00708734
Status:
COMPLETED
Last Update Posted:
2014-10-23
First Post:
2008-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise Intervention to Reduce Postural Instability in Osteoarthritis
Sponsor:
US Department of Veterans Affairs
Organization:
Study Overview
Official Title:
Exercise Intervention to Reduce Postural Instability in Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: