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Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment (WalkCog-MCI)

Primary Purpose

Cognitive Impairment

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Remediation Therapy Group

Walking Intervention (WI) Group

Combination Group

Healthy Living Group

About this trial

This is an interventional other trial for Cognitive Impairment

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cognitive Remediation Therapy Group

Walking Intervention Group

Combination Group

Healthy Living Group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Effects of interventions on cognition

Standard psychometric tests will be used to measure cognition

Secondary Outcome Measures

Effects of interventions on gait

Standard laboratory assessments and accelerometers will be used to measure gait.

Full Information

NCT ID

NCT01801943

First Posted

February 26, 2013

Last Updated

September 21, 2022

Sponsor

Pennington Biomedical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01801943

Brief Title

Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Acronym

WalkCog-MCI

Official Title

Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Terminated

Why Stopped

participants are no longer being examined or receiving intervention

Study Start Date

February 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a single blind randomized study designed to understand the effects of different interventions, walking interventions and cognitive remediation in particular, towards cognition and gait in the elderly. The study uses a 4 arm approach consisting of 4 intervention groups, with each intervention lasting for 12 weeks. The investigators will investigate the effect of each intervention towards cognitive function and gait. All interventions will be conducted on site at the Pennington Biomedical Research Center, and will be focused on determining the effects of different combinations of walking, cognitive remediation, healthy living courses, and reading. Cognitive measures will include objective clinical measures related to dementia, and the gait analysis will include in clinic and "free living" measures related to falls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Cognitive Remediation Therapy Group

Arm Type

Experimental

Arm Description

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

Arm Title

Walking Intervention Group

Arm Type

Experimental

Arm Description

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

Arm Title

Combination Group

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy Living Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Remediation Therapy Group

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Walking Intervention (WI) Group

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Combination Group

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Healthy Living Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Effects of interventions on cognition

Description

Standard psychometric tests will be used to measure cognition

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Effects of interventions on gait

Description

Standard laboratory assessments and accelerometers will be used to measure gait.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Keller, PhD

Organizational Affiliation

Pennington Biomedical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

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Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

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