Falls Prevention Program for Adults With Osteoarthritis

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Falls, Accidental
• Intervention / Treatment: Other: Otago Exercise Programme and Walk with Ease

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm - Intervention; Receives Otago Exercise Programme and Walk with Ease

Other: Otago Exercise Programme and Walk with Ease; The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Adherence to Intervention	Number of participants who adhere to the intervention.	6 months
Participant Safety With the Intervention	Number and type of adverse events related to the intervention.	6 months
Retention of Participants	Number of participants who participate in the study for the full 6 month program.	6 months
Acceptability of the Program	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Falls	Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.	Baseline to Month 6
Number of People With Severe of Falls	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.	Baseline to Month 6
Berg Balance Scale	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).	Baseline
Four-tests Balance: Feet Together Stand	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.	Baseline
Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Baseline
30-second Chair Stand Test	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.	Baseline
Timed Up and Go Test	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.	Baseline
Stair Climb Test	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.	Baseline
Western Ontario and McMaster Universities Osteoarthritis Index	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).	Baseline
Activities-specific Balance Confidence Scale	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.	Baseline
Rapid Assessment of Physical Activity: Aerobic Score	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: I rarely or never do any physical activities.Under-active:; I do some light or moderate physical activities, but not every week.Under-active regular - light activities:; I do some light physical activity every week.Under-active regular:; I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.; I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.Active:; I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.; I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.	Baseline
Berg Balance Scale	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).	Week 8
Berg Balance Scale	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).	Month 6
Four-tests Balance: Feet Together Stand	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.	Week 8
Four-tests Balance: Feet Together Stand	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.	Month 6
Four-tests Balance: Semi-tandem Stand	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.	Baseline
Four-tests Balance: Semi-tandem Stand	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.	Week 8
Four-tests Balance: Semi-tandem Stand	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.	Month 6
Four-tests Balance: Tandem Stand	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.	Baseline
Four-tests Balance: Tandem Stand	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.	Week 8
Four-tests Balance: Tandem Stand	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.	Month 6
Four-tests Balance: One Leg Stand	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.	Baseline
Four-tests Balance: One Leg Stand	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.	Week 8
Four-tests Balance: One Leg Stand	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.	Month 6
Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Week 8
Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Month 6
Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Baseline
Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Week 8
Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Month 6
30-second Chair Stand Test	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.	Week 8
30-second Chair Stand Test	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.	Month 6
Timed Up and Go Test	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.	Week 8
Timed Up and Go Test	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.	Month 6
Stair Climb Test	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.	Week 8
Stair Climb Test	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.	Month 6
Western Ontario and McMaster Universities Osteoarthritis Index	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).	Week 8
Western Ontario and McMaster Universities Osteoarthritis Index	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).	Month 6
Activities-specific Balance Confidence Scale	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.	Week 8
Activities-specific Balance Confidence Scale	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.	Month 6
Rapid Assessment of Physical Activity: Aerobic Score	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: I rarely or never do any physical activities.Under-active:; I do some light or moderate physical activities, but not every week.Under-active regular - light activities:; I do some light physical activity every week.Under-active regular:; I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.; I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.Active:; I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.; I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.	Week 8
Rapid Assessment of Physical Activity: Aerobic Score	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: I rarely or never do any physical activities.Under-active:; I do some light or moderate physical activities, but not every week.Under-active regular - light activities:; I do some light physical activity every week.Under-active regular:; I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.; I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.Active:; I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.; I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.	Month 6

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Yvonne Golightly, PT, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2015
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 15-1448