Back to resultsA Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
Primary Purpose
Mobility Limitation
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
InVEST: Increased Velocity Exercise Specific to Task
TAPAT: Tonic and Phasic Alertness Training
Sponsored by
About this trial
This is an interventional prevention trial for Mobility Limitation focused on measuring Rehabilitation, Aging, Mobility Skills, Cognitive Training
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
Sites / Locations
- VA Boston Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional Power + Cognitive Training
Functional Power Training
Arm Description
Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.
Training sessions began with 40 minutes of functional power training.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from Baseline Figure-of-8 Performance 6 weeks
Change from Baseline 400 Meter Walk Test at 6 weeks
Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
Range: 0-12; higher score better physical performance
Change from Baseline Cognitive Performance at 6 weeks
Change from Baseline Trail Making Test at 6 weeks
Change from Baseline Clock-in-the-Box Test at 6 weeks
Change from Baseline Letter Fluency Test at 6 weeks
Change from Baseline Hopkins Verbal Learning Test at 6 weeks
Full Information
NCT ID
NCT04446455
First Posted
June 16, 2020
Last Updated
June 22, 2020
Sponsor
VA Boston Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT04446455
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Boston Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
Rehabilitation, Aging, Mobility Skills, Cognitive Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized Pilot Study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Power + Cognitive Training
Arm Type
Experimental
Arm Description
Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training.
Arm Title
Functional Power Training
Arm Type
Active Comparator
Arm Description
Training sessions began with 40 minutes of functional power training.
Intervention Type
Other
Intervention Name(s)
InVEST: Increased Velocity Exercise Specific to Task
Intervention Description
Functional Power Training
Intervention Type
Other
Intervention Name(s)
TAPAT: Tonic and Phasic Alertness Training
Intervention Description
Computerized cognitive training.
Primary Outcome Measure Information:
Title
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
Description
Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Figure-of-8 Performance 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline 400 Meter Walk Test at 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
Description
Range: 0-12; higher score better physical performance
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Cognitive Performance at 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Trail Making Test at 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Clock-in-the-Box Test at 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Letter Fluency Test at 6 weeks
Time Frame
Baseline, 6 weeks
Title
Change from Baseline Hopkins Verbal Learning Test at 6 weeks
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
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