Walking Interventions, Cognitive Remediation and Mild Cog... | NCT01801943

Studies
Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

NCT01801943

Sponsor

Pennington Biomedical Research Center

Status

Terminated

Last Update Posted

Sep 23, 2022Actual

Enrollment

Not provided

Phase

Not Applicable

Conditions

Cognitive Impairment

Interventions

Cognitive Remediation Therapy Group
Walking Intervention (WI) Group
Combination Group
Healthy Living Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

participants are no longer being examined or receiving intervention

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 26, 2013

First Submission Date that Met QC Criteria

Feb 27, 2013

First Posted Date

Mar 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2022

Last Update Posted Date

Sep 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Remediation Therapy Group	Experimental	30 minute Cognitive Remediation Therapy and 60 minute Healthy Living Class three time per week	Behavioral: Cognitive Remediation Therapy Group
Walking Intervention Group	Experimental	60 minutes of walking and 30 minutes of reading stimulation three times a week	Behavioral: Walking Intervention (WI) Group
Combination Group	Experimental	30 minutes of Cognitive Remediation therapy and 60 minutes of walking three times a week	Behavioral: Combination Group
Healthy Living Group	Experimental	60 minute Healthy Living Class and 30 minutes of reading stimulation three times a week.	Behavioral: Healthy Living Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Remediation Therapy Group	Behavioral	30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week	Cognitive Remediation Therapy Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D003710	Demography
D011154	Population Characteristics