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

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation
• Intervention / Treatment: Other: InVEST: Increased Velocity Exercise Specific to Task; Other: TAPAT: Tonic and Phasic Alertness Training

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years to 86 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Power + Cognitive Training; 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; Functional Power Training; Other: TAPAT: Tonic and Phasic Alertness Training; Computerized cognitive training.
Active Comparator: Functional Power Training; Training sessions began with 40 minutes of functional power training.	Other: InVEST: Increased Velocity Exercise Specific to Task; Functional Power Training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Aging; Cognitive Training; Mobility Skills
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 3014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No