Mobility Optimization Through Velocity Exercise

Knee Osteoarthritis Clinical Trial

— MOVE  

Official title:

Optimizing Mobility in Older Adults With Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00844558
• Other study ID #: 200807706
• Secondary ID: K23AG030945-01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 13, 2009
• Last updated: December 1, 2011
• Start date: August 2008
• Est. completion date: June 2012

Study information

• Verified date: December 2011
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: June 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• Power Training
Power exercise training with an exercise specialist 2/week for 3 months, followed by by training with the exercise specialist 1/week and training at home 1/week for 3 months
• Control
There is no intervention associated with this arm of the study

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advanced Lower Limb Function: Late Life Function and Disability Instrument		1,3,6, and 12 months	No
Secondary	Impairment: knee pain, stair climb power		0,3,6 and 12 months	No
Secondary	Functional limitation: timed stair climb, summary performance score, long distance corridor walk		0,3,6 and 12 months	No
Secondary	Knee-Related Quality of Life		0,3,6 and 12 months	No