Effect of Exercise on Cognitive FunctionPhase 3EXACTNCT01603784
Combining Exercise and Cognitive Training to Improve Everyday Function
A Phase 3 study testing Intensive Exercise, Home Exercise and Cognitive Training in people with Effect of Exercise on Cognitive Function, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Exercise on Cognitive Function
- What is being tested?
- Intensive Exercise, Home Exercise and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2013
- Phase
- Phase 3
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 55-75 years (inclusive)
- English-speaking
- sufficient visual and auditory perception to complete testing
- available informant (someone who knows the individual well)
- Clinical Dementia Rating of 0 (non-demented per the screening assessment).
Who cannot join
- participation in a regular exercise program in last 6 months
- participation in a cognitive training program in last 6 months
- inability to walk on a treadmill or ride an exercise bike
- less than a 10th grade education
- mild cognitive impairment or dementia
- cigarette smoking within the previous year
Show all 23Show fewer
- history of alcohol or substance abuse
- BMI greater than 35
- insulin-dependent diabetes
- major and/or unstable medical, neurological, or psychiatric disorder, including:
- active congestive heart failure
- unstable angina
- effort angina
- nocturnal angina
- MI within previous 6 months
- ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm
- resting blood pressure above 170 systolic or 100 diastolic
- chronic infections
- advanced arthritis
- contractures or weakness due to CVA that would prevent adequate performance of the exercises.
- disabling stroke
- late stage renal or liver disease
- major affective disorder with active symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.
- Conditions
- Effect of Exercise on Cognitive Function
- Being tested
- Intensive Exercise, Home Exercise, Cognitive Training, Health Education
- Keywords
- exercise, cognition, memory, adult
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive ExerciseBehavioural
Standardized aerobic training program that is individualized to each participant's fitness level, and supervised by a certified exercise specialist. Participants attend 3 training sessions per week for 6 months. The session begins with a 10-15 minute warm-up. Participants then exercise on a treadmill or stationary bike, followed by "cool-down" activities. Heart rate and rating of perceived exertion are used to evaluate exercise intensity. Participants begin at ~30 min/day 60-70% of HR max and/or an equivalent level of RPE, and progress to 45-50 minutes at 75-85% for HR max.
Home ExerciseBehavioural
Exercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. Each participant has a 60-minute sessions with an exercise trainer to teach them how to perform the exercises correctly. They are also given diagrams illustrating the exercises, along with written instructions. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes. They also go to the recreational center monthly to meet with an exercise trainer to ensure that they are doing the exercises correctly. Participants record their exercise activities on a calendar for the 6 months.
Cognitive TrainingBehavioural
Computer-based training that is is administered 3 days per week for 8 weeks during months 5 and 6. The training program focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. One day of the week is devoted to each of the three cognitive processes. Some training sessions include a homework assignment for application and practice of the target cognitive processes in everyday activities.
Health EducationBehavioural
Weekly educational sessions are administered during months 5 and 6, conducted at the recreational center by research staff. Sessions last 1 hour, and cover health and other topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and saving energy in one's home. At the completion of each session, participants are given a "homework" assignment.
| Study group | Role | What they receive |
|---|---|---|
| Combined | Experimental | Aerobic Exercise + Cognitive Training Receives: Behavioral: Intensive Exercise; Behavioral: Cognitive Training |
| Exercise | Experimental | Aerobic Exercise + Health Education Receives: Behavioral: Intensive Exercise; Behavioral: Health Education |
| Cognitive | Experimental | Home Exercise + Cognitive Training Receives: Behavioral: Home Exercise; Behavioral: Cognitive Training |
| Control | Experimental | Home Exercise + Health Education Receives: Behavioral: Home Exercise; Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory for Medical Information
This task measures the ability of the individual to learn and recall complex medical information, and the source of the information.
Measured: Change in memory task performance between baseline and 6 months
Cooking Breakfast task
Participants engage in a computerized laboratory simulation of a cooking task to assesses cognitive dimensions of planning, prospective memory, monitoring the progress of ongoing activity, anticipating potential problems, task switching, and task coordination.
Measured: Change in task performance between baseline and 6 months
Virtual Week task
Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities.
Measured: Change in task performance between baseline and 6 months
Secondary outcomes (9)
Activities of Daily Living--Yale Physical Activity Scale (YPAS)
Questionnaire that objectively measures frequency and time spent per week performing common physical activities, which are used to caculate total weekly metabolic work (KCals).
Measured: Baseline, Month 3, Month 6, Month 12
Uniform Data Set (UDS)
A standardized interview to ascertain and assess demographic information, health status, cognitive status, medications, and functional status. The interview is conducted with the research participant and a collateral source historian.
Measured: Baseline, Month 12
Geriatric Depression Scale
A 15-item questionnaire to assess for symptoms of depression.
Measured: Baseline, Month 12
Late Life Function & Disability Index (LLFDI)
A standardized questionnaire to assess performance of activities of daily living (ADLs) and the level of difficulty experienced while performing each activity.
Measured: Baseline, Month 6, Month 12
Pittsburgh Sleep Quality Index (PSQI)
Questionnaire to assess sleep quality and events in the prior month. Includes a section for roommate/bed partner response.
Measured: Baseline, Month 6, Month 12
Objective Physical Performance Tests
Physical Performance Test, Senior Fit Test, Dual Task Walking Speed. These tests objectively measure walking speed, muscle strength, balance, and coordination.
Measured: Baseline, Month 6
Prospective and Retrospective Memory Questionnaire (PMRQ)
Objective questionnaires to measure ability to learn and recall information.
Measured: Baseline, Month 6, Month 12
Peak Aerobic Power
The participant walks on a treadmill, with a progressively increased grade (level of incline)over a 8-15 minute period, with continuous measurements of expired oxygen and carbon dioxide. Information obtained is used to measure the total amount of work that the person performs during the test. The participant has continuous ECG monitoring during the test.
Measured: Baseline, Month 6
Cognitive assessment battery
Array of cognitive tasks to assess performance in a variety of areas. Includes Stroop (response time and attentional control), Trials A/B (sequencing), Crossing Off (motor control), Logical Memory (story recall), and Digit Symbol (corresponding symbols to digits).
Measured: Baseline, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Exercise on Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis Jewish Community Center, St. Louis Naturally Occurring Retirement Community (NORC)
- Responsible party
- Sponsor
- Investigators
- Ellen Binder, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603784
- Sponsor's protocol ID
- 201102416
- Other IDs
- 1R01AG034581-01
- Acronym
- EXACT
- Status last verified
- Aug 2014
- First submitted
- 2 May 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Exercise and Cognitive Training to Improve Everyday Function
- ClinicalTrials.gov ID
- NCT01603784
- Acronym / sponsor ID
- EXACT / 201102416
- Conditions
- Effect of Exercise on Cognitive Function
- Keywords
- exercise, cognition, memory, adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- St. Louis Jewish Community Center, St. Louis Naturally Occurring Retirement Community (NORC)
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 May 2012 (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 randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined | Experimental | Behavioral: Intensive Exercise, Behavioral: Cognitive TrainingAerobic Exercise + Cognitive Training |
| Exercise | Experimental | Behavioral: Intensive Exercise, Behavioral: Health EducationAerobic Exercise + Health Education |
| Cognitive | Experimental | Behavioral: Home Exercise, Behavioral: Cognitive TrainingHome Exercise + Cognitive Training |
| Control | Experimental | Behavioral: Home Exercise, Behavioral: Health EducationHome Exercise + Health Education |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 55-75 years (inclusive)
- English-speaking
- sufficient visual and auditory perception to complete testing
- available informant (someone who knows the individual well)
- Clinical Dementia Rating of 0 (non-demented per the screening assessment).
Key exclusion criteria (23 listed)
- participation in a regular exercise program in last 6 months
- participation in a cognitive training program in last 6 months
- inability to walk on a treadmill or ride an exercise bike
- less than a 10th grade education
- mild cognitive impairment or dementia
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 |
|---|---|---|
| Intensive ExerciseStandardized aerobic training program that is individualized to each participant's fitness level, and supervised by a certified exercise specialist. Participants attend 3 training sessions per week for 6 months. The session begins with a 10-15 minute warm-up. Participants then exercise on a treadmill or stationary bike, followed by "cool-down" activities. Heart rate and rating of perceived exertion are used to evaluate exercise intensity. Participants begin at ~30 min/day 60-70% of HR max and/or an equivalent level of RPE, and progress to 45-50 minutes at 75-85% for HR max. | Behavioural | Combined, Exercise |
| Home ExerciseExercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. Each participant has a 60-minute sessions with an exercise trainer to teach them how to perform the exercises correctly. They are also given diagrams illustrating the exercises, along with written instructions. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes. They also go to the recreational center monthly to meet with an exercise trainer to ensure that they are doing the exercises correctly. Participants record their exercise activities on a calendar for the 6 months. | Behavioural | Cognitive, Control |
| Cognitive TrainingComputer-based training that is is administered 3 days per week for 8 weeks during months 5 and 6. The training program focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. One day of the week is devoted to each of the three cognitive processes. Some training sessions include a homework assignment for application and practice of the target cognitive processes in everyday activities. | Behavioural | Cognitive, Combined |
| Health EducationWeekly educational sessions are administered during months 5 and 6, conducted at the recreational center by research staff. Sessions last 1 hour, and cover health and other topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and saving energy in one's home. At the completion of each session, participants are given a "homework" assignment. | Behavioural | Control, Exercise |
Primary outcome
Memory for Medical Information
Time frame: Change in memory task performance between baseline and 6 months
This task measures the ability of the individual to learn and recall complex medical information, and the source of the information.
Cooking Breakfast task
Time frame: Change in task performance between baseline and 6 months
Participants engage in a computerized laboratory simulation of a cooking task to assesses cognitive dimensions of planning, prospective memory, monitoring the progress of ongoing activity, anticipating potential problems, task switching, and task coordination.
Virtual Week task
Time frame: Change in task performance between baseline and 6 months
Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities.
9 secondary outcomes
Activities of Daily Living--Yale Physical Activity Scale (YPAS)
Time frame: Baseline, Month 3, Month 6, Month 12
Uniform Data Set (UDS)
Time frame: Baseline, Month 12
Geriatric Depression Scale
Time frame: Baseline, Month 12
Late Life Function & Disability Index (LLFDI)
Time frame: Baseline, Month 6, Month 12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Month 6, Month 12
Objective Physical Performance Tests
Time frame: Baseline, Month 6
Prospective and Retrospective Memory Questionnaire (PMRQ)
Time frame: Baseline, Month 6, Month 12
Peak Aerobic Power
Time frame: Baseline, Month 6
Cognitive assessment battery
Time frame: Baseline, Month 6, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Ellen Binder, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensive Exercise, Home Exercise and Cognitive Training in people with Effect of Exercise on Cognitive Function, run by Washington University School of Medicine 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 3 Sep 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Memory for Medical Information (time frame: Change in memory task performance between baseline and 6 months). The study lists 3 primary outcomes in all. 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 3 Sep 2014.