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Physical Activity and Cognition Study (CTSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773121
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:
The goal of this research study is to examine whether an intervention to increase physical activity using a body-worn sensor affects cognitive (thinking) processes.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Physical Activity Not Applicable

Detailed Description:
The overall duration of participation in this research study is approximately 4 months. During this time, three study visits will be required. The first visit is for informed consent and screening, the second visit is for baseline fitness and cognitive testing, and the third visit is for follow-up fitness and cognitive testing after a 12-week physical activity monitoring program. Participants will be randomized to one of two study arms, a physical activity monitoring arm and a flexibility and balance arm. Both study arms involve wearing a physical activity sensor and monitoring physical activity for a duration of 12 weeks.

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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

Resource links provided by the National Library of Medicine


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.
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.
Behavioral: Physical Activity
Trainer-guided at-home behavioral intervention




Primary Outcome Measures :
  1. Cognition [ Time Frame: 80-90 minutes ]
    Change in cognitive task performance post-intervention compared to baseline

  2. Aerobic Fitness [ Time Frame: 30 minutes ]
    Change aerobic fitness measured with treadmill test post-intervention


Secondary Outcome Measures :
  1. Functional fitness: Five Times Sit to Stand [ Time Frame: 10 min ]
    Change in performance in the Five Times Sit to Stand test post-intervention

  2. 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

  3. Functional fitness: Flexibility [ Time Frame: 10 min ]
    Change in performance in the Sit and Reach test post-intervention

  4. 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


Other Outcome Measures:
  1. Gait: step and stride time [ Time Frame: 12 weeks ]
    Change in step and stride time over 12 weeks

  2. Gait: stride time variability [ Time Frame: 12 weeks ]
    Change in stride time variability over 12 weeks

  3. Gait: gait symmetry [ Time Frame: 12 weeks ]
    Change in gait symmetry over 12 weeks



Information from the National Library of Medicine

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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
Criteria

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
  • Past or present conditions that affect cognitive functioning:

    1. learning disability
    2. neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
    3. psychiatric disorders or conditions (depression, anxiety disorder, etc.)
  • Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and moderate-intensity physical activity:

    1. heart conditions (e.g. heart attack, arrhythmias, etc.)
    2. circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)
    3. respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
    4. current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
    5. diagnosis of electrolyte disorder or abnormality
    6. 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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Karin Schon, Ph.D. Boston University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
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