Mobility Optimization Through Velocity Exercise (MOVE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Optimizing Mobility in Older Adults With Knee Osteoarthritis|
- Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]
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).
- Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 0,3,6, and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 0,3,6,and 12 months ] [ Designated as safety issue: No ]Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.
|Study Start Date:||August 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Gait Training
Gait Training Intervention Group Participants
Other: Gait Training
Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
Placebo Comparator: Control
Gait Training Control Group Participants
There is no intervention associated with this arm of the study
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844558
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Neil A Segal, MD, MS||University of Iowa|