Clinical trial NCT04446455: A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
Official title: A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mobility Limitation
Keywords: Rehabilitation
Aging
Mobility Skills
Cognitive Training
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2020-06-25
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Pilot Study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change from Baseline Figure-of-8 Performance 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline 400 Meter Walk Test at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Cognitive Performance at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Trail Making Test at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Clock-in-the-Box Test at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Letter Fluency Test at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from Baseline Hopkins Verbal Learning Test at 6 weeks
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
References: