NCT02567227

Brief Summary

The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 7, 2021

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

August 17, 2015

Results QC Date

March 15, 2021

Last Update Submit

February 22, 2024

Conditions

Mobility LimitationMotor ActivityDifficulty WalkingCognitive Ability General

Outcome Measures

Primary Outcomes (1)

  • Change in Walking Speed During Single and Dual-task Conditions.

    Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).

    Baseline and 2 months

Secondary Outcomes (15)

  • Change in Short Physical Performance Battery (SPPB).

    Baseline and 2 months

  • Stride Length.

    Baseline and 2 months

  • Gait Variability.

    Baseline and 2 months

  • Variability in Gait Domains

    Baseline and 2 Months

  • Number of Participants With Substantial Gait Speed Change.

    Baseline and 2 Months

  • +10 more secondary outcomes

Other Outcomes (9)

  • The Geriatric Depression Scale (GDS).

    Baseline and 2 months

  • Rosenberg Self-Esteem Scale.

    Baseline and 2 months

  • Falls Efficacy Scale.

    Baseline and 2 months

  • +6 more other outcomes

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

An individualized computerized cognitive remediation program.

Other: Cognitive Remediation

Active control

ACTIVE COMPARATOR

Individualized computer based exposure and interactive health education classes.

Other: Active Control

Interventions

Cognitive RemediationOTHER

This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.

Cognitive Remediation
Active ControlOTHER

Computer, multimedia and group based health education programs.

Active control

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults aged 70 and older, residing in the community.
  • Plan to be in area for next year.
  • Able to speak English at a level sufficient to undergo our cognitive assessment battery.
  • Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
  • Gait velocity ≤1 m/s.
  • Short Physical Performance Battery score ≤9.

You may not qualify if:

  • Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of \<5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment.
  • Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
  • Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.
  • Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
  • Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
  • Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
  • Severe auditory or visual loss.
  • Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
  • Living in nursing home.
  • Participation in other intervention trial or observational studies. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (3)

  • Verghese J, Mahoney J, Ambrose AF, Wang C, Holtzer R. Effect of cognitive remediation on gait in sedentary seniors. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1338-43. doi: 10.1093/gerona/glq127. Epub 2010 Jul 19.

    PMID: 20643703RESULT

  • Verghese J, Mahoney JR, Ayers E, Ambrose A, Wang C, Holtzer R. Computerised cognitive remediation to enhance mobility in older adults: a single-blind, single-centre, randomised trial. Lancet Healthy Longev. 2021 Sep;2(9):e571-e579. doi: 10.1016/s2666-7568(21)00173-2. Epub 2021 Sep 2.

    PMID: 34522910DERIVED

  • Verghese J, Ayers E, Mahoney JR, Ambrose A, Wang C, Holtzer R. Cognitive remediation to enhance mobility in older adults: the CREM study. Neurodegener Dis Manag. 2016 Dec;6(6):457-466. doi: 10.2217/nmt-2016-0034. Epub 2016 Nov 4.

    PMID: 27813452DERIVED

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Joe Verghese
Organization
Albert Einstein College of Medicine
joe.verghese@einsteinmed.org
718-430-3877

Study Officials

  • Joe Verghese, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Roee Holtzer, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

October 2, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

February 28, 2024

Results First Posted

June 7, 2021

Record last verified: 2024-02

Locations

US(1)