NCT01801943

Brief Summary

The purpose of this study is to determine the effects of a coordinated intervention of cognitive remediation training (CRT) and walking intervention on cognition and gait in the elderly.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 23, 2022

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

February 26, 2013

Last Update Submit

September 21, 2022

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Effects of interventions on cognition

    Standard psychometric tests will be used to measure cognition

    6 months

Secondary Outcomes (1)

  • Effects of interventions on gait

    6 months

Study Arms (4)

Cognitive Remediation Therapy Group

EXPERIMENTAL

30 minute Cognitive Remediation Therapy and 60 minute Healthy Living Class three time per week

Behavioral: Cognitive Remediation Therapy Group

Walking Intervention Group

EXPERIMENTAL

60 minutes of walking and 30 minutes of reading stimulation three times a week

Behavioral: Walking Intervention (WI) Group

Combination Group

EXPERIMENTAL

30 minutes of Cognitive Remediation therapy and 60 minutes of walking three times a week

Behavioral: Combination Group

Healthy Living Group

EXPERIMENTAL

60 minute Healthy Living Class and 30 minutes of reading stimulation three times a week.

Behavioral: Healthy Living Group

Interventions

Cognitive Remediation Therapy GroupBEHAVIORAL

30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week

Cognitive Remediation Therapy Group
Walking Intervention (WI) GroupBEHAVIORAL

60 min Walking Intervention + 30 min low interface reading 3x week

Walking Intervention Group
Combination GroupBEHAVIORAL

30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week

Combination Group
Healthy Living GroupBEHAVIORAL

60 Min Healthy Living class + 30 min low interface reading 3x week

Healthy Living Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women meeting all criteria listed below will be included in the study:
  • Subjects between 65-85 years of age inclusive
  • Subjects with Short Physical Performance Battery of 10 or greater
  • Subjects averaging less than 5,000 steps per day
  • Subjects with Mini Mental State Exam 25-28, inclusive
  • Subjects with normal for age physical-neurological exam
  • Subjects able to walk a city block without a walking aid
  • Written Informed Consent obtained PRIOR to performing any study procedures

You may not qualify if:

  • Subjects with difficult walking due to pain or posture
  • Subjects with difficulty in using computer due to significant visual and/or fine motor impairment
  • Subjects with large weight loss (\>15 Kilogram) in the last 12 months
  • Subjects with geriatric depression scale \> 9.
  • Subjects with Malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled
  • Subjects with abnormal electrocardiogram results. These include: a resting heart rate below 40 bpm or above 100 bpm, previously unknown and/or untreated atrial fibrillation or flutter, evidence of a third degree A-V block, a previously undocumented left bundle branch block, S-T segment depression of greater than 2 mm, evidence of a previous MI, or any other findings that in the clinical judgment of the medical investigator preclude participation in an exercise intervention.
  • Subjects with shortness of breath, exertional angina, uncontrolled high blood pressure or any other chronic medical condition deemed by the physician to preclude participation in an exercise intervention.
  • Subjects with any other medical condition or disease that is life-threatening or that can interfere with, or be aggravated by, exercise.
  • Subjects who currently smoke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Jeffrey Keller, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 23, 2022

Record last verified: 2014-06

Locations

US(1)