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Exercise Intervention to Reduce Postural Instability in Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00708734
First received: June 27, 2008
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: functional exercise training

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Intervention to Reduce Postural Instability in Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Gait and Balance Measures [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.


Enrollment: 10
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
functional exercise training
Behavioral: functional exercise training
twice weekly group sessions for 5 weeks

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708734

Locations
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33637-1022
Sponsors and Collaborators
Investigators
Principal Investigator: Tatjana Bulat, MD James A. Haley Veterans' Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00708734     History of Changes
Other Study ID Numbers: F5070-R
Study First Received: June 27, 2008
Results First Received: October 1, 2014
Last Updated: October 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
exercise

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014