Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Cognitive Impairment Clinical Trial

— WalkCog-MCI  

Official title:

Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01801943
• Other study ID #: PBRC 12032
• Status: Terminated
• Phase: N/A
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2014
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• Cognitive Remediation Therapy Group
30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week
• Walking Intervention (WI) Group
60 min Walking Intervention + 30 min low interface reading 3x week
• Combination Group
30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week
• Healthy Living Group
60 Min Healthy Living class + 30 min low interface reading 3x week

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of interventions on cognition	Standard psychometric tests will be used to measure cognition	6 months
Secondary	Effects of interventions on gait	Standard laboratory assessments and accelerometers will be used to measure gait.	6 months