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

Early Phase 1

Completed

• Conditions: Mobility Limitation

• Registration Number: NCT04446455
• Lead Sponsor: VA Boston Healthcare System

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.

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks	Baseline, 6 weeks	Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Cognitive Performance at 6 weeks	Baseline, 6 weeks
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	Range: 0-12; higher score better physical performance
Change from Baseline Letter Fluency Test 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 Hopkins Verbal Learning Test at 6 weeks	Baseline, 6 weeks

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States