Knee Osteoarthritis
Conditions
Keywords
osteoarthritis, knee pain, gait training, power training, rehabilitation, physical therapy
Brief summary
Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.
Detailed description
The long-term objective of this research is to reduce disablement of older adults with knee osteoarthritis (OA). This will be accomplished through assessing changes in functional limitations (standing and walking) that occur with 2 mobility-specific interventions. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. However, there is uncertainty whether intervening to increase muscle power or to improve gait mechanics would be most effective for optimizing mobility in older adults with knee OA. Although gait training may be most specific for improving gait, this approach currently requires supervised physical therapy and expensive equipment. In contrast, power training may be less costly and more convenient if conducted at home. To optimize mobility in older adults with symptomatic knee OA, there is a need to study each of these mobility-specific interventions in a randomized controlled trial (RCT). Successful completion of this trial will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect. Specific Aim 1: Assess the efficacy of two innovative interventions for improving mobility limitations, disability and quality of life in older adults with symptomatic knee OA. Primary Hypothesis: For older adults with symptomatic knee OA, in comparison with usual care (control group), a 3-month a) patient-specific gait training intervention and b) mobility-specific power training intervention will reduce lower limb mobility limitations assessed using the Function component of the Late Life Function and Disability Index (LLFDI-Function). Hypothesis 2: Improved mobility will be maintained at 6 and 12-month follow-up (3 and 9 months following transitioning to home-based training) for each of the 2 intervention groups who receive the combination of the home-based intervention and encouragement to continue participation. Hypothesis 3: In comparison to baseline measures, at 3, 6, and 12-month follow-up, each of the 2 intervention groups will demonstrate improvements in a) disability (LDCW), b) quality of life assessed using the Knee Osteoarthritis Outcome Score questionnaire Quality of Life component(KOOS Knee QOL), and c) knee OA specific outcome scores using the pain subscale component of KOOS.
Interventions
OTHERGait Training
Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
OTHERControl
There is no intervention associated with this arm of the study
Sponsors
National Institute on Aging (NIA)
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60 or older * Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
Exclusion criteria
* bilateral knee replacement * acute or terminal illness * unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or current medical condition that affects walking, or lower limb musculoskeletal surgery in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | 0,3,6, and 12 months | This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities. Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | 0,3,6 and 12 months | This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no pain. |
| Change in KOOS Symptoms | 0,3,6 and 12 months | This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no symptoms. |
| Change in Long Distance Corridor Walk (LDCW) Time, Secs | 0,3,6 and 12 months | The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale. |
| Change in Stair Climb Time, Secs | 0,3,6, and 12 months | Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm) |
| Change in Chair Stand Time | 0,3,6,and 12 months | Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gait The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback. | 36 |
| Control The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy. | 22 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 2 |
Baseline characteristics
| Characteristic | Gait | Control | Total |
|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 7.3 | 69.6 years STANDARD_DEVIATION 6.4 | 69.3 years STANDARD_DEVIATION 7.35 |
| Region of Enrollment United States | 36 participants | 22 participants | 58 participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 32 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 22 |
| serious Total, serious adverse events | 0 / 36 | 0 / 22 |
Outcome results
Primary
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument
This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities. Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance).
Time frame: 0,3,6, and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 3 | 3.3 units on a scale |
| Gait | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 6 | 3.1 units on a scale |
| Gait | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 12 | 3.9 units on a scale |
| Control Group | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 3 | -1.0 units on a scale |
| Control Group | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 6 | 0.8 units on a scale |
| Control Group | Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument | Change from baseline to month 12 | 2.9 units on a scale |
Secondary
Change in Chair Stand Time
Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.
Time frame: 0,3,6,and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in Chair Stand Time | Change from baseline to month 3 | -0.9 seconds |
| Gait | Change in Chair Stand Time | Change from baseline to month 6 | -1.9 seconds |
| Gait | Change in Chair Stand Time | Change from baseline to month 12 | -2.5 seconds |
| Control Group | Change in Chair Stand Time | Change from baseline to month 3 | -1.0 seconds |
| Control Group | Change in Chair Stand Time | Change from baseline to month 6 | -3.0 seconds |
| Control Group | Change in Chair Stand Time | Change from baseline to month 12 | -2.9 seconds |
Secondary
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain
This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no pain.
Time frame: 0,3,6 and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 3 | 8.2 units on a scale |
| Gait | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 6 | 5.4 units on a scale |
| Gait | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 12 | 10.1 units on a scale |
| Control Group | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 3 | 1.1 units on a scale |
| Control Group | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 6 | 1.7 units on a scale |
| Control Group | Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain | Change from baseline to month 12 | 2.8 units on a scale |
Secondary
Change in KOOS Symptoms
This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no symptoms.
Time frame: 0,3,6 and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in KOOS Symptoms | Change from baseline to month 3 | 11.5 units on a scale |
| Gait | Change in KOOS Symptoms | Change from baseline to month 6 | 8.1 units on a scale |
| Gait | Change in KOOS Symptoms | Change from baseline to month 12 | 8.5 units on a scale |
| Control Group | Change in KOOS Symptoms | Change from baseline to month 3 | 3.0 units on a scale |
| Control Group | Change in KOOS Symptoms | Change from baseline to month 6 | 1.8 units on a scale |
| Control Group | Change in KOOS Symptoms | Change from baseline to month 12 | 2.4 units on a scale |
Secondary
Change in Long Distance Corridor Walk (LDCW) Time, Secs
The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.
Time frame: 0,3,6 and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 3 | 11.5 seconds |
| Gait | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 6 | 8.1 seconds |
| Gait | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 12 | 8.5 seconds |
| Control Group | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 3 | 3.0 seconds |
| Control Group | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 6 | 1.8 seconds |
| Control Group | Change in Long Distance Corridor Walk (LDCW) Time, Secs | Change from baseline to month 12 | 2.4 seconds |
Secondary
Change in Stair Climb Time, Secs
Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)
Time frame: 0,3,6, and 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gait | Change in Stair Climb Time, Secs | Change from baseline to month 3 | 0.2 seconds |
| Gait | Change in Stair Climb Time, Secs | Change from baseline to month 6 | -0.2 seconds |
| Gait | Change in Stair Climb Time, Secs | Change from baseline to month 12 | -0.3 seconds |
| Control Group | Change in Stair Climb Time, Secs | Change from baseline to month 3 | 0.0 seconds |
| Control Group | Change in Stair Climb Time, Secs | Change from baseline to month 6 | -1.4 seconds |
| Control Group | Change in Stair Climb Time, Secs | Change from baseline to month 12 | -1.1 seconds |