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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04446455
Enrollment
25
Registered
2020-06-25
Start date
2018-05-01
Completion date
2018-11-15
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobility Limitation

Keywords

Rehabilitation, Aging, Mobility Skills, Cognitive Training

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.

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.

Interventions

OTHERInVEST: Increased Velocity Exercise Specific to Task

Functional Power Training

OTHERTAPAT: Tonic and Phasic Alertness Training

Computerized cognitive training.

Sponsors

VA Boston Healthcare System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Randomized Pilot Study

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Late-Life Function and Disability Instrument at 6 weeksBaseline, 6 weeksFunction domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument

Secondary

MeasureTime frameDescription
Change from Baseline Figure-of-8 Performance 6 weeksBaseline, 6 weeks
Change from Baseline 400 Meter Walk Test at 6 weeksBaseline, 6 weeks
Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeksBaseline, 6 weeksRange: 0-12; higher score better physical performance
Change from Baseline Clock-in-the-Box Test at 6 weeksBaseline, 6 weeks
Change from Baseline Trail Making Test at 6 weeksBaseline, 6 weeks
Change from Baseline Letter Fluency Test at 6 weeksBaseline, 6 weeks
Change from Baseline Hopkins Verbal Learning Test at 6 weeksBaseline, 6 weeks
Change from Baseline Cognitive Performance at 6 weeksBaseline, 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026