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CompletedNCT00708734Updated Oct 23, 2014Results posted

Exercise Intervention to Reduce Postural Instability in Osteoarthritis

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

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
50 Years and older
Sex
All
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Study 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 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).

02

Conditions studied

  • Osteoarthritis

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Keywords

  • exercise
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In context

Osteoarthritis

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Arm 1

    functional exercise training

    Behavioral: functional exercise training

Interventions

  • Behavioralfunctional exercise training

    twice weekly group sessions for 5 weeks

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What researchers measure

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.

    Time frame: 5 months

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Results

Posted Oct 23, 2014

Participant flow

Participant flow — Overall Study
MilestoneArm 1
Started10
Completed3
Not completed7
Withdrew: Scheduling conflict2
Withdrew: Moved1
Withdrew: Leg injury1
Withdrew: Knee replacement1
Withdrew: Vertigo1
Withdrew: Leg fracture1

Outcome measures

PrimaryGait 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

No measurements were reported for this outcome.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Functional Exercise Training—0/10 (0%)0/10 (0%)

Baseline characteristics

age over 50 and gender

Age, Continuous
Age, Continuous(years)Functional Exercise Training
Mean66.5 (50 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Functional Exercise Training
Female1
Male9
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Study locations

1 site
  • James A. Haley Veterans' Hospital
    Tampa, Florida 33637-1022, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00708734
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Jul 2, 2008
Start date
Jul 2008
Primary completion
Jul 2009
Completion
Nov 2009
Results posted
Oct 23, 2014
Last update
Oct 23, 2014

Study contacts

Tatjana Bulat, MD
principal investigator · James A. Haley Veterans' Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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