Cognitive ImpairmentWalkCog-MCINCT01801943
Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment
A study testing Cognitive Remediation Therapy Group, Walking Intervention (WI) Group and Combination Group in people with Cognitive Impairment, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Cognitive Remediation Therapy Group, Walking Intervention (WI) Group and Combination Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
- Conditions
- Cognitive Impairment
- Being tested
- Cognitive Remediation Therapy Group, Walking Intervention (WI) Group, Combination Group, Healthy Living Group
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation Therapy GroupBehavioural
30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week
Walking Intervention (WI) GroupBehavioural
60 min Walking Intervention + 30 min low interface reading 3x week
Combination GroupBehavioural
30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week
Healthy Living GroupBehavioural
60 Min Healthy Living class + 30 min low interface reading 3x week
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation Therapy Group | Experimental | 30 minute Cognitive Remediation Therapy and 60 minute Healthy Living Class three time per week Receives: Behavioral: Cognitive Remediation Therapy Group |
| Walking Intervention Group | Experimental | 60 minutes of walking and 30 minutes of reading stimulation three times a week Receives: Behavioral: Walking Intervention (WI) Group |
| Combination Group | Experimental | 30 minutes of Cognitive Remediation therapy and 60 minutes of walking three times a week Receives: Behavioral: Combination Group |
| Healthy Living Group | Experimental | 60 minute Healthy Living Class and 30 minutes of reading stimulation three times a week. Receives: Behavioral: Healthy Living Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of interventions on cognition
Standard psychometric tests will be used to measure cognition
Measured: 6 months
Secondary outcomes (1)
Effects of interventions on gait
Standard laboratory assessments and accelerometers will be used to measure gait.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Keller, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801943
- Sponsor's protocol ID
- PBRC 12032
- Acronym
- WalkCog-MCI
- Status last verified
- Jun 2014
- First submitted
- 26 Feb 2013
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01801943
- Acronym / sponsor ID
- WalkCog-MCI / PBRC 12032
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participants are no longer being examined or receiving intervention
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy Group | Experimental | Behavioral: Cognitive Remediation Therapy Group30 minute Cognitive Remediation Therapy and 60 minute Healthy Living Class three time per week |
| Walking Intervention Group | Experimental | Behavioral: Walking Intervention (WI) Group60 minutes of walking and 30 minutes of reading stimulation three times a week |
| Combination Group | Experimental | Behavioral: Combination Group30 minutes of Cognitive Remediation therapy and 60 minutes of walking three times a week |
| Healthy Living Group | Experimental | Behavioral: Healthy Living Group60 minute Healthy Living Class and 30 minutes of reading stimulation three times a week. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation Therapy Group30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week | Behavioural | Cognitive Remediation Therapy Group |
| Walking Intervention (WI) Group60 min Walking Intervention + 30 min low interface reading 3x week | Behavioural | Walking Intervention Group |
| Combination Group30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week | Behavioural | Combination Group |
| Healthy Living Group60 Min Healthy Living class + 30 min low interface reading 3x week | Behavioural | Healthy Living Group |
Primary outcome
Effects of interventions on cognition
Time frame: 6 months
Standard psychometric tests will be used to measure cognition
1 secondary outcome
Effects of interventions on gait
Time frame: 6 months
Results and safety
The study was stopped early (reason given: participants are no longer being examined or receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Keller, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy Group, Walking Intervention (WI) Group and Combination Group in people with Cognitive Impairment, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: participants are no longer being examined or receiving intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of interventions on cognition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.