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TerminatedNCT01801943WalkCog-MCIUpdated Sep 23, 2022

Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

An interventional study of Cognitive Remediation Therapy Group and Walking Intervention (WI) Group in Cognitive Impairment, sponsored by Pennington Biomedical Research Center. Terminated at 1 site in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Other

Why this study was terminated
participants are no longer being examined or receiving intervention
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Impairment
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

Browse Cognitive Dysfunction studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.

Browse Pennington Biomedical Research Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)

Study arms

  • 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

  • Experimental
    Walking Intervention Group

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

    Behavioral: Walking Intervention (WI) Group

  • Experimental
    Combination Group

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

    Behavioral: Combination Group

  • Experimental
    Healthy Living Group

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

    Behavioral: Healthy Living Group

Interventions

  • BehavioralCognitive Remediation Therapy Group

    30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week

  • BehavioralWalking Intervention (WI) Group

    60 min Walking Intervention + 30 min low interface reading 3x week

  • BehavioralCombination Group

    30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week

  • BehavioralHealthy Living Group

    60 Min Healthy Living class + 30 min low interface reading 3x week

06

What researchers measure

Primary outcomes

  1. Effects of interventions on cognition

    Standard psychometric tests will be used to measure cognition

    Time frame: 6 months

Secondary outcomes

  1. Effects of interventions on gait

    Standard laboratory assessments and accelerometers will be used to measure gait.

    Time frame: 6 months

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2013
First posted
Mar 1, 2013
Start
Feb 2013
Primary completionActual
Nov 2014
CompletionActual
Nov 2014
Last update
Sep 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01801943
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Sponsor
First posted
Mar 1, 2013
Start date
Feb 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Sep 23, 2022

Study contacts

Jeffrey Keller, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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