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Clinical Trials/NCT01801943
NCT01801943TerminatedNot Applicable

Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Pennington Biomedical Research Center1 site in 1 countryStarted: February 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Locations
1
Primary Endpoint
Effects of interventions on cognition

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
65 Years to 85 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 >
  • •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.

Arms & Interventions

Cognitive Remediation Therapy Group

Experimental

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

Intervention: Cognitive Remediation Therapy Group (Behavioral)

Walking Intervention Group

Experimental

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

Intervention: Walking Intervention (WI) Group (Behavioral)

Combination Group

Experimental

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

Intervention: Combination Group (Behavioral)

Healthy Living Group

Experimental

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

Intervention: Healthy Living Group (Behavioral)

Outcomes

Primary Outcomes

Effects of interventions on cognition

Time Frame: 6 months

Standard psychometric tests will be used to measure cognition

Secondary Outcomes

  • Effects of interventions on gait(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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