Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

NCT ID: NCT01801943

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive Remediation Therapy Group

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

Group Type EXPERIMENTAL

Cognitive Remediation Therapy Group

Intervention Type BEHAVIORAL

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

Walking Intervention Group

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

Group Type EXPERIMENTAL

Walking Intervention (WI) Group

Intervention Type BEHAVIORAL

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

Combination Group

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

Group Type EXPERIMENTAL

Combination Group

Intervention Type BEHAVIORAL

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

Healthy Living Group

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

Group Type EXPERIMENTAL

Healthy Living Group

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Remediation Therapy Group

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

Intervention Type BEHAVIORAL

Walking Intervention (WI) Group

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

Intervention Type BEHAVIORAL

Combination Group

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

Intervention Type BEHAVIORAL

Healthy Living Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Keller, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 12032

Identifier Type: -

Identifier Source: org_study_id

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