Clinical trial NCT02648646: Falls Prevention Program for Adults With Osteoarthritis
Official title: Falls Prevention Program for Adults With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Falls, Accidental
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Participant Adherence to Intervention
timeFrame: 6 months
measure: Participant Safety With the Intervention
timeFrame: 6 months
measure: Retention of Participants
timeFrame: 6 months
measure: Acceptability of the Program
timeFrame: 6 months
Secondary outcomes:
measure: Number of Falls
timeFrame: Baseline to Month 6
measure: Number of People With Severe of Falls
timeFrame: Baseline to Month 6
measure: Berg Balance Scale
timeFrame: Baseline
measure: Four-tests Balance: Feet Together Stand
timeFrame: Baseline
measure: Hand Grip Dynamometry Right Hand
timeFrame: Baseline
measure: 30-second Chair Stand Test
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: Baseline
measure: Stair Climb Test
timeFrame: Baseline
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Baseline
measure: Activities-specific Balance Confidence Scale
timeFrame: Baseline
measure: Rapid Assessment of Physical Activity: Aerobic Score
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: Week 8
measure: Berg Balance Scale
timeFrame: Month 6
measure: Four-tests Balance: Feet Together Stand
timeFrame: Week 8
measure: Four-tests Balance: Feet Together Stand
timeFrame: Month 6
measure: Four-tests Balance: Semi-tandem Stand
timeFrame: Baseline
measure: Four-tests Balance: Semi-tandem Stand
timeFrame: Week 8
measure: Four-tests Balance: Semi-tandem Stand
timeFrame: Month 6
measure: Four-tests Balance: Tandem Stand
timeFrame: Baseline
measure: Four-tests Balance: Tandem Stand
timeFrame: Week 8
measure: Four-tests Balance: Tandem Stand
timeFrame: Month 6
measure: Four-tests Balance: One Leg Stand
timeFrame: Baseline
measure: Four-tests Balance: One Leg Stand
timeFrame: Week 8
measure: Four-tests Balance: One Leg Stand
timeFrame: Month 6
measure: Hand Grip Dynamometry Right Hand
timeFrame: Week 8
measure: Hand Grip Dynamometry Right Hand
timeFrame: Month 6
measure: Hand Grip Dynamometry Left Hand
timeFrame: Baseline
measure: Hand Grip Dynamometry Left Hand
timeFrame: Week 8
measure: Hand Grip Dynamometry Left Hand
timeFrame: Month 6
measure: 30-second Chair Stand Test
timeFrame: Week 8
measure: 30-second Chair Stand Test
timeFrame: Month 6
measure: Timed Up and Go Test
timeFrame: Week 8
measure: Timed Up and Go Test
timeFrame: Month 6
measure: Stair Climb Test
timeFrame: Week 8
measure: Stair Climb Test
timeFrame: Month 6
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Week 8
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Month 6
measure: Activities-specific Balance Confidence Scale
timeFrame: Week 8
measure: Activities-specific Balance Confidence Scale
timeFrame: Month 6
measure: Rapid Assessment of Physical Activity: Aerobic Score
timeFrame: Week 8
measure: Rapid Assessment of Physical Activity: Aerobic Score
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yvonne Golightly, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: