Physical Activity and Cognition Study (CTSI)
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ClinicalTrials.gov Identifier: NCT02773121 |
Recruitment Status :
Completed
First Posted : May 16, 2016
Last Update Posted : April 21, 2020
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Condition or disease | Intervention/treatment | Phase |
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Aging | Behavioral: Physical Activity | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Feasibility of Using Physical Activity Monitoring for Enhancing Cognition in Healthy Seniors |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | January 17, 2020 |
Actual Study Completion Date : | January 17, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Physical activity monitoring
Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their physical activity level to at least 150 min of moderate-intensity physical activity per week. They will be asked to follow guidelines in the "Go4Life" brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises.
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Behavioral: Physical Activity
Trainer-guided at-home behavioral intervention |
Active Comparator: Flexibility and balance
Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their balance and flexibility over the 12 week period of the intervention. They will be asked to follow guidelines in the "Go4Life" brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises.
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Behavioral: Physical Activity
Trainer-guided at-home behavioral intervention |
- Cognition [ Time Frame: 80-90 minutes ]Change in cognitive task performance post-intervention compared to baseline
- Aerobic Fitness [ Time Frame: 30 minutes ]Change aerobic fitness measured with treadmill test post-intervention
- Functional fitness: Five Times Sit to Stand [ Time Frame: 10 min ]Change in performance in the Five Times Sit to Stand test post-intervention
- Functional fitness: Timed Get Up and Go [ Time Frame: 10 min ]Change in performance in the Timed Get Up and Go test post-intervention compared to baseline
- Functional fitness: Flexibility [ Time Frame: 10 min ]Change in performance in the Sit and Reach test post-intervention
- Physical activity [ Time Frame: 12 weeks ]Greater overall moderate-intensity physical activity time and step count and lower sedentary time in the physical activity monitoring than the flexibility and balance group
- Gait: step and stride time [ Time Frame: 12 weeks ]Change in step and stride time over 12 weeks
- Gait: stride time variability [ Time Frame: 12 weeks ]Change in stride time variability over 12 weeks
- Gait: gait symmetry [ Time Frame: 12 weeks ]Change in gait symmetry over 12 weeks

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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Non-smoking
- Age between 55-85 years
- Sedentary status (physically inactive; not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months)
- Generally healthy men and women
- Living in the greater Boston area
- Available for the 4 month duration of the study
- Native-English speaking or fluent in English (must have attended elementary school and higher in English)
Exclusion Criteria:
- Poor vision that cannot be corrected with glasses or contact lenses
- Presence of an acute infection
- Diagnosis of kidney failure
- Diagnosis of liver disease
- Diagnosis of thyrotoxicosis/hyperthyroidism
- Diagnosis of cancer
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Past or present conditions that affect cognitive functioning:
- learning disability
- neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
- psychiatric disorders or conditions (depression, anxiety disorder, etc.)
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Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and moderate-intensity physical activity:
- heart conditions (e.g. heart attack, arrhythmias, etc.)
- circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)
- respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
- current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
- diagnosis of electrolyte disorder or abnormality
- presence of diabetes mellitus
- Obesity
- Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.)
- Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.)
- Implanted medical devices, such as a pacemaker or defibrillator
- Unavailable for the approx. 4-month duration of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773121
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Karin Schon, Ph.D. | Boston University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boston University |
ClinicalTrials.gov Identifier: | NCT02773121 |
Other Study ID Numbers: |
H-34352 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | April 21, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cognition Learning Memory Executive Function Attention Neuropsychological Tests Physical Activity Physical Fitness |
Exercise Resistance Training Walking Muscle Stretching Exercises Exercise Test Balance Flexibility Body Composition |