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Completed

NCT Number: NCT02648646

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Otago Exercise Programme and Walk with Ease

Other

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.

Primary outcomes

  1. Participant Adherence to Intervention

    Time frame: 6 months

    Number of participants who adhere to the intervention.

  2. Participant Safety With the Intervention

    Time frame: 6 months

    Number and type of adverse events related to the intervention.

  3. Retention of Participants

    Time frame: 6 months

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

  4. 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.

Secondary outcomes

  1. Number of Falls

    Time frame: Baseline 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.

  2. Number of People With Severe of Falls

    Time frame: Baseline 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.

  3. Berg Balance Scale

    Time frame: Baseline

    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).

  4. Four-tests Balance: Feet Together Stand

    Time frame: Baseline

    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.

  5. Hand Grip Dynamometry Right Hand

    Time frame: Baseline

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

  6. 30-second Chair Stand Test

    Time frame: Baseline

    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.

  7. Timed Up and Go Test

    Time frame: Baseline

    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.

  8. Stair Climb Test

    Time frame: Baseline

    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.

  9. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Baseline

    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).

  10. Activities-specific Balance Confidence Scale

    Time frame: Baseline

    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.

  11. Rapid Assessment of Physical Activity: Aerobic Score

    Time frame: Baseline

    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.
  12. Berg Balance Scale

    Time frame: Week 8

    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).

  13. Berg Balance Scale

    Time frame: Month 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).

  14. Four-tests Balance: Feet Together Stand

    Time frame: Week 8

    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.

  15. Four-tests Balance: Feet Together Stand

    Time frame: Month 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.

  16. Four-tests Balance: Semi-tandem Stand

    Time frame: Baseline

    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.

  17. Four-tests Balance: Semi-tandem Stand

    Time frame: Week 8

    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.

  18. Four-tests Balance: Semi-tandem Stand

    Time frame: Month 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.

  19. Four-tests Balance: Tandem Stand

    Time frame: Baseline

    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.

  20. Four-tests Balance: Tandem Stand

    Time frame: Week 8

    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.

  21. Four-tests Balance: Tandem Stand

    Time frame: Month 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.

  22. Four-tests Balance: One Leg Stand

    Time frame: Baseline

    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.

  23. Four-tests Balance: One Leg Stand

    Time frame: Week 8

    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.

  24. Four-tests Balance: One Leg Stand

    Time frame: Month 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.

  25. Hand Grip Dynamometry Right Hand

    Time frame: Week 8

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

  26. Hand Grip Dynamometry Right Hand

    Time frame: Month 6

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

  27. Hand Grip Dynamometry Left Hand

    Time frame: Baseline

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

  28. Hand Grip Dynamometry Left Hand

    Time frame: Week 8

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

  29. Hand Grip Dynamometry Left Hand

    Time frame: Month 6

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

  30. 30-second Chair Stand Test

    Time frame: Week 8

    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.

  31. 30-second Chair Stand Test

    Time frame: Month 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.

  32. Timed Up and Go Test

    Time frame: Week 8

    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.

  33. Timed Up and Go Test

    Time frame: Month 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.

  34. Stair Climb Test

    Time frame: Week 8

    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.

  35. Stair Climb Test

    Time frame: Month 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.

  36. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Week 8

    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).

  37. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Month 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).

  38. Activities-specific Balance Confidence Scale

    Time frame: Week 8

    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.

  39. Activities-specific Balance Confidence Scale

    Time frame: Month 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.

  40. Rapid Assessment of Physical Activity: Aerobic Score

    Time frame: Week 8

    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.
  41. Rapid Assessment of Physical Activity: Aerobic Score

    Time frame: Month 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:

    • 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2016
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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