Clinical trial NCT01801943: Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment
Official title: Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-03-01
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Effects of interventions on cognition
timeFrame: 6 months
Secondary outcomes:
measure: Effects of interventions on gait
timeFrame: 6 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jeffrey Keller, PhD
role: PRINCIPAL_INVESTIGATOR
References: