Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2014 by Pennington Biomedical Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jeffrey Keller, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01801943
First received: February 26, 2013
Last updated: June 6, 2014
Last verified: June 2014
  Purpose
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.

Condition Intervention
Cognitive Impairment
Behavioral: Cognitive Remediation Therapy Group
Behavioral: Walking Intervention (WI) Group
Behavioral: Combination Group
Behavioral: Healthy Living Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Effects of interventions on cognition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Standard psychometric tests will be used to measure cognition


Secondary Outcome Measures:
  • Effects of interventions on gait [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Standard laboratory assessments and accelerometers will be used to measure gait.


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801943

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Jeffrey Keller, PhD    225-763-3190    doctors@pbrc.edu   
Contact: Robert M. Brouillette, PhD    225-763-0277    doctors@pbrc.edu   
Principal Investigator: Jeffrey N Keller, PhD         
Sub-Investigator: Patrick Gahan, MD         
Sub-Investigator: Catrine Tudor-Locke, PhD         
Sub-Investigator: Corby Martin, PhD         
Sub-Investigator: William Johnson, PhD         
Sub-Investigator: Robert M. Brouillette, M.S.         
Sub-Investigator: Heather Walden, M.S.         
Sub-Investigator: Allison Davis, M.S.         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Jeffrey Keller, PhD Pennington Biomedical Research Center
  More Information

Responsible Party: Jeffrey Keller, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01801943     History of Changes
Other Study ID Numbers: WalkCog-MCI 
Study First Received: February 26, 2013
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 27, 2016