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Falls Prevention Program for Adults With Osteoarthritis

Falls Prevention Program for Adults With Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02648646
Enrollment
10
Registered
2016-01-07
Start date
2015-11-02
Completion date
2016-10-31
Last updated
2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls, Accidental, Osteoarthritis

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).

Interventions

OTHEROtago 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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant Adherence to Intervention6 monthsNumber of participants who adhere to the intervention.
Participant Safety With the Intervention6 monthsNumber and type of adverse events related to the intervention.
Retention of Participants6 monthsNumber of participants who participate in the study for the full 6 month program.
Acceptability of the Program6 monthsDescriptive 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

MeasureTime frameDescription
Hand Grip Dynamometry Right HandBaselineParticipant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
30-second Chair Stand TestBaselineParticipant 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 TestBaselineParticipant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
Stair Climb TestBaselineParticipant 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.
Western Ontario and McMaster Universities Osteoarthritis IndexBaselineThis 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).
Number of FallsBaseline to Month 6Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.
Rapid Assessment of Physical Activity: Aerobic ScoreBaselineParticipants 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.
Four-tests Balance: Semi-tandem StandBaselineFour 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 StandBaselineFour 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: One Leg StandBaselineFour 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 HandBaselineParticipant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Activities-specific Balance Confidence ScaleBaselineParticipant 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.
Number of People With Severe of FallsBaseline to Month 6Participant 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.
Berg Balance ScaleBaselineThis 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: Feet Together StandBaselineFour 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.

Participant flow

Participants by arm

ArmCount
Single Arm - Intervention
Receives Otago Exercise Programme and Walk with Ease 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.
10
Total10

Baseline characteristics

CharacteristicSingle Arm - Intervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
10 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous71.3 years
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
4 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

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.

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Single Arm - InterventionAcceptability of the ProgramReported no dislikes of program6 Participants
Single Arm - InterventionAcceptability of the ProgramLiked exercising with this program2 Participants
Single Arm - InterventionAcceptability of the ProgramThe program helped individual move better3 Participants
Single Arm - InterventionAcceptability of the ProgramExercises were easy1 Participants
Single Arm - InterventionAcceptability of the ProgramLiked the program gave structure1 Participants
Single Arm - InterventionAcceptability of the ProgramLiked that program promoted working towards goals1 Participants
Single Arm - InterventionAcceptability of the ProgramDid not like Walk With Ease workbook, hard to use1 Participants
Single Arm - InterventionAcceptability of the ProgramOne exercise hurt hip; PT changed it & was fin1 Participants
Single Arm - InterventionAcceptability of the ProgramChallenge of program: standing on 1 foot3 Participants
Single Arm - InterventionAcceptability of the ProgramChallenge of program: needed to hold onto counter1 Participants
Single Arm - InterventionAcceptability of the ProgramExercises were challenging at first1 Participants
Single Arm - InterventionAcceptability of the ProgramChallenging to learn new exercises1 Participants
Single Arm - InterventionAcceptability of the ProgramChallenge to make self do program on own1 Participants
Single Arm - InterventionAcceptability of the ProgramNo challenges with program1 Participants
Single Arm - InterventionAcceptability of the ProgramPlans to continue to practice what they learned8 Participants
Primary

Participant Adherence to Intervention

Number of participants who adhere to the intervention.

Time frame: 6 months

Population: 8 participants completed the 6-month intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single Arm - InterventionParticipant Adherence to Intervention5 Participants
Primary

Participant Safety With the Intervention

Number and type of adverse events related to the intervention.

Time frame: 6 months

Population: 8 participants completed the 6-month intervention

ArmMeasureValue (NUMBER)
Single Arm - InterventionParticipant Safety With the Intervention0 adverse events
Primary

Retention of Participants

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

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Single Arm - InterventionRetention of ParticipantsCompleted8 Participants
Single Arm - InterventionRetention of ParticipantsReason not completed: total knee replacement1 Participants
Single Arm - InterventionRetention of ParticipantsReason not compelted: Injury not related to study1 Participants
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - Intervention30-second Chair Stand Test9 completed maneuvers
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - Intervention30-second Chair Stand Test7.5 completed maneuvers
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - Intervention30-second Chair Stand Test9 completed maneuvers
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionActivities-specific Balance Confidence Scale60.6 percentage of confidence
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionActivities-specific Balance Confidence Scale64.1 percentage of confidence
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionActivities-specific Balance Confidence Scale59.1 percentage of confidence
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).

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionBerg Balance Scale47.5 units on a scale
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).

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionBerg Balance Scale49.5 units on a scale
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).

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionBerg Balance Scale48 units on a scale
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Feet Together Stand10.0 seconds
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Feet Together Stand10 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Feet Together Stand10.0 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: One Leg Stand0.9 seconds
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: One Leg Stand0.0 seconds
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: One Leg Stand0.0 seconds
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Semi-tandem Stand10.0 seconds
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Semi-tandem Stand7.4 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Semi-tandem Stand10.0 seconds
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Tandem Stand10.0 seconds
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Tandem Stand0.0 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionFour-tests Balance: Tandem Stand5.2 seconds
Secondary

Hand Grip Dynamometry Left Hand

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

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Left Hand16.7 kilograms
Secondary

Hand Grip Dynamometry Left Hand

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

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Left Hand17.0 kilograms
Secondary

Hand Grip Dynamometry Left Hand

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

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Left Hand16.7 kilograms
Secondary

Hand Grip Dynamometry Right Hand

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

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Right Hand15.7 kilograms
Secondary

Hand Grip Dynamometry Right Hand

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

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Right Hand17.7 kilograms
Secondary

Hand Grip Dynamometry Right Hand

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

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionHand Grip Dynamometry Right Hand15.0 kilograms
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.

Time frame: Baseline to Month 6

ArmMeasureValue (NUMBER)
Single Arm - InterventionNumber of Falls3 falls
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.

Time frame: Baseline to Month 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single Arm - InterventionNumber of People With Severe of Falls1 Participants
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: 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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionRapid Assessment of Physical Activity: Aerobic Score4 units on a scale
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: 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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionRapid Assessment of Physical Activity: Aerobic Score4 units on a scale
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: 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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionRapid Assessment of Physical Activity: Aerobic Score3.5 units on a scale
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionStair Climb Test9.8 seconds
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionStair Climb Test9.0 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionStair Climb Test8.8 seconds
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.

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionTimed Up and Go Test16.8 seconds
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.

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionTimed Up and Go Test19.5 seconds
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.

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionTimed Up and Go Test21.6 seconds
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).

Time frame: Week 8

ArmMeasureValue (MEDIAN)
Single Arm - InterventionWestern Ontario and McMaster Universities Osteoarthritis Index31 units on a scale
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).

Time frame: Month 6

ArmMeasureValue (MEDIAN)
Single Arm - InterventionWestern Ontario and McMaster Universities Osteoarthritis Index23.5 units on a scale
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).

Time frame: Baseline

ArmMeasureValue (MEDIAN)
Single Arm - InterventionWestern Ontario and McMaster Universities Osteoarthritis Index37 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026