OsteoarthritisNCT02648646
Falls Prevention Program for Adults With Osteoarthritis
A study testing Otago Exercise Programme and Walk with Ease in people with Osteoarthritis and Falls, Accidental, run by University of North Carolina, Chapel Hill.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Falls, Accidental
- What is being tested?
- Otago Exercise Programme and Walk with Ease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
- Conditions
- Osteoarthritis, Falls, Accidental
- Being tested
- Otago Exercise Programme and Walk with Ease
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise Programme and Walk with EaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Intervention | Experimental | Receives Otago Exercise Programme and Walk with Ease Receives: Other: Otago Exercise Programme and Walk with Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adherence to Intervention
Number of participants who adhere to the intervention.
Measured: 6 months
Participant Safety With the Intervention
Number and type of adverse events related to the intervention.
Measured: 6 months
Retention of Participants
Number of participants who participate in the study for the full 6 month program.
Measured: 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.
Measured: 6 months
Secondary outcomes (41)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline
Hand Grip Dynamometry Right Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Hand Grip Dynamometry Right Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: Week 8
Hand Grip Dynamometry Right Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: Month 6
Hand Grip Dynamometry Left Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: Baseline
Hand Grip Dynamometry Left Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: Week 8
Hand Grip Dynamometry Left Hand
Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start2 Nov 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Golightly, PT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648646
- Sponsor's protocol ID
- 15-1448
- Status last verified
- Jul 2017
- First submitted
- 2 Nov 2015
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls Prevention Program for Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02648646
- Acronym / sponsor ID
- 15-1448
- Conditions
- Osteoarthritis, Falls, Accidental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Intervention | Experimental | Other: Otago Exercise Programme and Walk with EaseReceives Otago Exercise Programme and Walk with Ease |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise Programme and Walk with EaseThe 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. | Other | Single Arm - Intervention |
Primary outcome
Participant Adherence to Intervention
Time frame: 6 months
Number of participants who adhere to the intervention.
Participant Safety With the Intervention
Time frame: 6 months
Number and type of adverse events related to the intervention.
Retention of Participants
Time frame: 6 months
Number of participants who participate in the study for the full 6 month program.
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.
41 secondary outcomes
Number of Falls
Time frame: Baseline to Month 6
Number of People With Severe of Falls
Time frame: Baseline to Month 6
Berg Balance Scale
Time frame: Baseline
Four-tests Balance: Feet Together Stand
Time frame: Baseline
Hand Grip Dynamometry Right Hand
Time frame: Baseline
30-second Chair Stand Test
Time frame: Baseline
Timed Up and Go Test
Time frame: Baseline
Stair Climb Test
Time frame: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline
Activities-specific Balance Confidence Scale
Time frame: Baseline
Rapid Assessment of Physical Activity: Aerobic Score
Time frame: Baseline
Berg Balance Scale
Time frame: Week 8
Berg Balance Scale
Time frame: Month 6
Four-tests Balance: Feet Together Stand
Time frame: Week 8
Four-tests Balance: Feet Together Stand
Time frame: Month 6
Four-tests Balance: Semi-tandem Stand
Time frame: Baseline
Four-tests Balance: Semi-tandem Stand
Time frame: Week 8
Four-tests Balance: Semi-tandem Stand
Time frame: Month 6
Four-tests Balance: Tandem Stand
Time frame: Baseline
Four-tests Balance: Tandem Stand
Time frame: Week 8
Four-tests Balance: Tandem Stand
Time frame: Month 6
Four-tests Balance: One Leg Stand
Time frame: Baseline
Four-tests Balance: One Leg Stand
Time frame: Week 8
Four-tests Balance: One Leg Stand
Time frame: Month 6
Hand Grip Dynamometry Right Hand
Time frame: Week 8
Hand Grip Dynamometry Right Hand
Time frame: Month 6
Hand Grip Dynamometry Left Hand
Time frame: Baseline
Hand Grip Dynamometry Left Hand
Time frame: Week 8
Hand Grip Dynamometry Left Hand
Time frame: Month 6
30-second Chair Stand Test
Time frame: Week 8
30-second Chair Stand Test
Time frame: Month 6
Timed Up and Go Test
Time frame: Week 8
Timed Up and Go Test
Time frame: Month 6
Stair Climb Test
Time frame: Week 8
Stair Climb Test
Time frame: Month 6
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 8
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Month 6
Activities-specific Balance Confidence Scale
Time frame: Week 8
Activities-specific Balance Confidence Scale
Time frame: Month 6
Rapid Assessment of Physical Activity: Aerobic Score
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Golightly, PT, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Programme and Walk with Ease in people with Osteoarthritis and Falls, Accidental, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Adherence to Intervention (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.