Mobility Optimization Through Velocity Exercise

NCT ID: NCT00844558

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-10-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gait Training

Gait Training Intervention Group Participants

Group Type: EXPERIMENTAL

Gait Training

Intervention Type: OTHER

Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months

Control

Gait Training Control Group Participants

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

There is no intervention associated with this arm of the study

Interventions

Gait Training

Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months

Intervention Type: OTHER

Control

There is no intervention associated with this arm of the study

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Neil A Segal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil A Segal, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

K23AG030945-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200807706

Identifier Type: -

Identifier Source: org_study_id