A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention

Conditions
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Mobility Limitation

Intervention / Treatment
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* Other: InVEST: Increased Velocity Exercise Specific to Task
* Other: TAPAT: Tonic and Phasic Alertness Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Pilot Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Power + Cognitive Training<br>Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training. | Other: InVEST: Increased Velocity Exercise Specific to Task<br>* Functional Power Training<br>Other: TAPAT: Tonic and Phasic Alertness Training<br>* Computerized cognitive training.<br>|
| Active Comparator: Functional Power Training<br>Training sessions began with 40 minutes of functional power training. | Other: InVEST: Increased Velocity Exercise Specific to Task<br>* Functional Power Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Late-Life Function and Disability Instrument at 6 weeks | Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Range: 0-12; higher score better physical performance | Baseline, 6 weeks | 
| Change from Baseline Cognitive Performance 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 Letter Fluency Test at 6 weeks |  | Baseline, 6 weeks | 
| Change from Baseline Hopkins Verbal Learning Test at 6 weeks |  | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobility Skills, Cognitive Training, Rehabilitation, Aging