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

Veterans Affairs (VA) Boston Healthcare System

Status and phase: Completed; Early Phase 1

Conditions: Mobility Limitation

Treatments: Other: InVEST: Increased Velocity Exercise Specific to Task; Other: TAPAT: Tonic and Phasic Alertness Training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04446455

3014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Functional Power + Cognitive Training

Experimental group

Description:

Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.

Treatment:

Other: TAPAT: Tonic and Phasic Alertness Training

Other: InVEST: Increased Velocity Exercise Specific to Task

Functional Power Training

Active Comparator group

Description:

Training sessions began with 40 minutes of functional power training.

Treatment:

Other: InVEST: Increased Velocity Exercise Specific to Task