Falls Prevention Program for Adults With Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Falls Prevention Program for Adults With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648646
• Other study ID #: 15-1448
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: July 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Falls, Accidental
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Adherence to Intervention	Number of participants who adhere to the intervention.	6 months
Primary	Participant Safety With the Intervention	Number and type of adverse events related to the intervention.	6 months
Primary	Retention of Participants	Number of participants who participate in the study for the full 6 month program.	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Week 8
Secondary	Hand Grip Dynamometry Right Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Month 6
Secondary	Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Baseline
Secondary	Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Week 8
Secondary	Hand Grip Dynamometry Left Hand	Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.	Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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