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

NCT04446455 | Completed Early Phase 1

• 1 other identifier: 3014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobility Limitation

Keywords

Rehabilitation; Aging; Mobility Skills; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

Study Arms (2)

Functional Power + Cognitive Training

EXPERIMENTAL

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; Other: TAPAT: Tonic and Phasic Alertness Training

Functional Power Training

ACTIVE COMPARATOR

Training sessions began with 40 minutes of functional power training.

Other: InVEST: Increased Velocity Exercise Specific to Task

Interventions

InVEST: Increased Velocity Exercise Specific to Task OTHER

Functional Power Training

Functional Power + Cognitive Training; Functional Power Training

TAPAT: Tonic and Phasic Alertness Training OTHER

Computerized cognitive training.

Functional Power + Cognitive Training

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, New England Geriatric Research Education and Clinical Center

Model Details: Randomized Pilot Study

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 25, 2020
• Study Start: May 1, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)