A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Mobility Limitation
- Sponsor
- VA Boston Healthcare System
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care Veterans 65 years and older.
Detailed Description
This study is a randomized control pilot study. All participants will receive rehabilitative exercise addressing mobility skills. In addition, one group will be will receive additional cognitive training. Randomization is stratified according to screening mobility and cognitive score.
Investigators
Jonathan F. Bean
Director, New England Geriatric Research Education and Clinical Center
VA Boston Healthcare System
Eligibility Criteria
Inclusion Criteria
- •Age 65-90
- •History of fall in the past year OR difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks)
- •Community Dwelling
- •Ability to speak and understand English
Exclusion Criteria
- •Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer
- •Major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen
- •Myocardial infarction or major surgery in previous 3 months
- •Planned major surgery (e.g. joint replacement)
- •Baseline Short Physical Performance Battery Score \<4 or \>10
- •Modified Mini Mental Status Examination score of ≤77 out of 100
- •Inability to safely complete the 400 meter walk test
Outcomes
Primary Outcomes
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
Time Frame: Baseline, 6 weeks
Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
Secondary Outcomes
- Change from Baseline Cognitive Performance at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Figure-of-8 Performance 6 weeks(Baseline, 6 weeks)
- Change from Baseline 400 Meter Walk Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Letter Fluency Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Trail Making Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Clock-in-the-Box Test at 6 weeks(Baseline, 6 weeks)
- Change from Baseline Hopkins Verbal Learning Test at 6 weeks(Baseline, 6 weeks)