MedPath

Falls Prevention Program for Adults With Osteoarthritis

Not Applicable
Completed
Conditions
Falls, Accidental
Osteoarthritis
Interventions
Other: Otago Exercise Programme and Walk with Ease
Registration Number
NCT02648646
Lead Sponsor
University of North Carolina, Chapel Hill
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Single Arm - InterventionOtago Exercise Programme and Walk with EaseReceives Otago Exercise Programme and Walk with Ease
Primary Outcome Measures
NameTimeMethod
Participant Adherence to Intervention6 months

Number of participants who adhere to the intervention.

Retention of Participants6 months

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

Acceptability of the Program6 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 Intervention6 months

Number and type of adverse events related to the intervention.

Secondary Outcome Measures
NameTimeMethod
Number of FallsBaseline to Month 6

Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.

Four-tests Balance: Feet Together StandMonth 6

Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.

Hand Grip Dynamometry Right HandMonth 6

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Number of People With Severe of FallsBaseline to Month 6

Participant will record whether the fall resulted in an injury and the type of injury that occurred. A fall will be considered severe if an injury occurred.

Stair Climb TestMonth 6

Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.

30-second Chair Stand TestMonth 6

Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.

Timed Up and Go TestMonth 6

Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.

Western Ontario and McMaster Universities Osteoarthritis IndexMonth 6

This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).

Rapid Assessment of Physical Activity: Aerobic ScoreMonth 6

Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels.

Sedentary:

1. I rarely or never do any physical activities.

Under-active:

2. I do some light or moderate physical activities, but not every week.

Under-active regular - light activities:

3. I do some light physical activity every week.

Under-active regular:

4. I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.

5. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.

Active:

6. I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.

7. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.

Berg Balance ScaleMonth 6

This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).

Four-tests Balance: One Leg StandMonth 6

Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.

Activities-specific Balance Confidence ScaleMonth 6

Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.

Four-tests Balance: Semi-tandem StandMonth 6

Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.

Four-tests Balance: Tandem StandMonth 6

Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.

Hand Grip Dynamometry Left HandMonth 6

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

© Copyright 2025. All Rights Reserved by MedPath