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Clinical Trials/NCT02648646
NCT02648646
Completed
Not Applicable

Falls Prevention Program for Adults With Osteoarthritis

University of North Carolina, Chapel Hill0 sites10 target enrollmentNovember 2, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of North Carolina, Chapel Hill
Enrollment
10
Primary Endpoint
Participant Adherence to Intervention
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Purpose: To report the feasibility and to obtain preliminary data on the effects of using an enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis (OA).

Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA, are at risk for falls, and are 65+ years old.

Procedures (methods): All participants will receive the 6-month enhanced Otago program. The investigators will assemble data: quantifying participant adherence to and safety of the intervention, ascertaining retention of participants for 6 months, determining acceptability of the program, and other validated measures (e.g., number of falls and fall severity, balance measures).

Registry
clinicaltrials.gov
Start Date
November 2, 2015
End Date
October 31, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • history of falls
  • knee or hip radiographic OA
  • 65+ years of age
  • normal cognitive function (based on the Mini-Mental State Examination)
  • current knee/hip symptoms

Exclusion Criteria

  • hospitalized for stroke, myocardial infarction, or coronary artery revascularization in past 3 months
  • diagnosis of metastatic cancer in the past 3 months
  • terminal illness
  • progressive neurological disorders
  • rheumatoid arthritis
  • severe fibromyalgia
  • other systemic rheumatic disease

Outcomes

Primary Outcomes

Participant Adherence to Intervention

Time Frame: 6 months

Number of participants who adhere to the intervention.

Retention of Participants

Time Frame: 6 months

Number of participants who participate in the study for the full 6 month program.

Acceptability of the Program

Time Frame: 6 months

Descriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.

Participant Safety With the Intervention

Time Frame: 6 months

Number and type of adverse events related to the intervention.

Secondary Outcomes

  • Number of Falls(Baseline to Month 6)
  • Four-tests Balance: Feet Together Stand(Month 6)
  • Hand Grip Dynamometry Right Hand(Month 6)
  • Number of People With Severe of Falls(Baseline to Month 6)
  • Stair Climb Test(Month 6)
  • 30-second Chair Stand Test(Month 6)
  • Timed Up and Go Test(Month 6)
  • Western Ontario and McMaster Universities Osteoarthritis Index(Month 6)
  • Rapid Assessment of Physical Activity: Aerobic Score(Month 6)
  • Berg Balance Scale(Month 6)
  • Four-tests Balance: One Leg Stand(Month 6)
  • Activities-specific Balance Confidence Scale(Month 6)
  • Four-tests Balance: Semi-tandem Stand(Month 6)
  • Four-tests Balance: Tandem Stand(Month 6)
  • Hand Grip Dynamometry Left Hand(Month 6)

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