Exercise Intervention to Reduce Postural Instability in Osteoarthritis

NCT00708734 | Completed Results

• 1 other identifier: F5070-R
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

• Gait and Balance Measures

  Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.

  5 months

Study Arms (1)

Arm 1

EXPERIMENTAL

functional exercise training

Behavioral: functional exercise training

Interventions

functional exercise training BEHAVIORAL

twice weekly group sessions for 5 weeks

Arm 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

James A. Haley Veterans' Hospital

Tampa, Florida, 33637-1022, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Results Point of Contact

• Title: Tatjana Bulat
• Organization: Tampa VA Hospital

tatjana.bulat@va.gov

8135583932

Study Officials

• Tatjana Bulat, MD

  James A. Haley Veterans' Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 23, 2014
• Results First Posted: October 23, 2014

Record last verified: 2014-10

Locations

US (1)