Mobility Optimization Through Velocity Exercise (MOVE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT00844558
First received: February 13, 2009
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Other: Gait Training
Other: Power Training
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Advanced Lower Limb Function: Late Life Function and Disability Instrument [ Time Frame: 1,3,6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impairment: knee pain, stair climb power [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]
  • Functional limitation: timed stair climb, summary performance score, long distance corridor walk [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]
  • Knee-Related Quality of Life [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: August 2008
Estimated Study Completion Date: June 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gait
Gait Training Arm
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
Experimental: Power
Power Training Arm
Other: 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
Placebo Comparator: Control
Control Group
Other: Control
There is no intervention associated with this arm of the study

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844558

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Neil A Segal, MD, MS University of Iowa
  More Information

No publications provided

Responsible Party: Neil A Segal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00844558     History of Changes
Other Study ID Numbers: 200807706, K23AG030945-01
Study First Received: February 13, 2009
Last Updated: December 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
osteoarthritis
knee pain
gait training
power training
rehabilitation
physical therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014