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

Mobility Limitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446455
• Other study ID #: 3014
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: June 2020
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Other:
• InVEST: Increased Velocity Exercise Specific to Task
Functional Power Training
• TAPAT: Tonic and Phasic Alertness Training
Computerized cognitive training.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 6 weeks
Secondary	Change from Baseline Figure-of-8 Performance 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline 400 Meter Walk Test at 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks	Range: 0-12; higher score better physical performance	Baseline, 6 weeks
Secondary	Change from Baseline Cognitive Performance at 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline Trail Making Test at 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline Clock-in-the-Box Test at 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline Letter Fluency Test at 6 weeks		Baseline, 6 weeks
Secondary	Change from Baseline Hopkins Verbal Learning Test at 6 weeks		Baseline, 6 weeks