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OpenTrials
Completed

NCT Number: NCT04446455

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.

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InVEST: Increased Velocity Exercise Specific to Task

Other

Functional Power Training

TAPAT: Tonic and Phasic Alertness Training

Other

Computerized cognitive training.

Primary outcomes

  1. Change from Baseline Late-Life Function and Disability Instrument at 6 weeks

    Time frame: Baseline, 6 weeks

    Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument

Secondary outcomes

  1. Change from Baseline Figure-of-8 Performance 6 weeks

    Time frame: Baseline, 6 weeks

  2. Change from Baseline 400 Meter Walk Test at 6 weeks

    Time frame: Baseline, 6 weeks

  3. Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks

    Time frame: Baseline, 6 weeks

    Range: 0-12; higher score better physical performance

  4. Change from Baseline Cognitive Performance at 6 weeks

    Time frame: Baseline, 6 weeks

  5. Change from Baseline Trail Making Test at 6 weeks

    Time frame: Baseline, 6 weeks

  6. Change from Baseline Clock-in-the-Box Test at 6 weeks

    Time frame: Baseline, 6 weeks

  7. Change from Baseline Letter Fluency Test at 6 weeks

    Time frame: Baseline, 6 weeks

  8. Change from Baseline Hopkins Verbal Learning Test at 6 weeks

    Time frame: Baseline, 6 weeks

Sponsors and collaborators

Lead sponsor

VA Boston Healthcare System

Fed

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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