Mobility Optimization Through Velocity Exercise (MOVE)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT00844558
First received: February 13, 2009
Last updated: May 2, 2016
Last verified: May 2016
  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: Control

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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.


Enrollment: 58
Study Start Date: August 2008
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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   (Adult, Senior)
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
National Institute on Aging (NIA)
Investigators
Principal Investigator: Neil A Segal, MD, MS University of Iowa
  More Information

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
Results First Received: July 2, 2015
Last Updated: May 2, 2016
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 27, 2016