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

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.

Study Overview

• Status: Terminated
• Conditions: Cognitive Impairment
• Intervention / Treatment: Behavioral: Cognitive Remediation Therapy Group; Behavioral: Walking Intervention (WI) Group; Behavioral: Combination Group; Behavioral: Healthy Living Group

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Remediation Therapy Group; 30 minute Cognitive Remediation Therapy and 60 minute Healthy Living Class three time per week	Behavioral: Cognitive Remediation Therapy Group; 30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week
Experimental: Walking Intervention Group; 60 minutes of walking and 30 minutes of reading stimulation three times a week	Behavioral: Walking Intervention (WI) Group; 60 min Walking Intervention + 30 min low interface reading 3x week
Experimental: Combination Group; 30 minutes of Cognitive Remediation therapy and 60 minutes of walking three times a week	Behavioral: Combination Group; 30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week
Experimental: Healthy Living Group; 60 minute Healthy Living Class and 30 minutes of reading stimulation three times a week.	Behavioral: Healthy Living Group; 60 Min Healthy Living class + 30 min low interface reading 3x week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of interventions on cognition	Standard psychometric tests will be used to measure cognition	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of interventions on gait	Standard laboratory assessments and accelerometers will be used to measure gait.	6 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Jeffrey Keller, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PBRC 12032