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

NCT ID: NCT04446455

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-11-15

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.

Conditions

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Mobility Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Pilot Study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

InVEST: Increased Velocity Exercise Specific to Task

Intervention Type OTHER

Functional Power Training

TAPAT: Tonic and Phasic Alertness Training

Intervention Type OTHER

Computerized cognitive training.

Functional Power Training

Training sessions began with 40 minutes of functional power training.

Group Type ACTIVE_COMPARATOR

InVEST: Increased Velocity Exercise Specific to Task

Intervention Type OTHER

Functional Power Training

Interventions

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InVEST: Increased Velocity Exercise Specific to Task

Functional Power Training

Intervention Type OTHER

TAPAT: Tonic and Phasic Alertness Training

Computerized cognitive training.

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Jonathan F. Bean

Director, New England Geriatric Research Education and Clinical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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3014

Identifier Type: -

Identifier Source: org_study_id

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