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

V

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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