Physical Activity and Cognition Study (CTSI)

• ClinicalTrials.gov Identifier: NCT02773121
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: April 21, 2020
• Sponsor: Boston University
• Information provided by (Responsible Party): Boston University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

Boston University School of Medicine

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

Investigators

• Principal Investigator: Karin Schon, Ph.D.; Boston University

More Information

Additional Information:

Brain Plasticity and Neuroimaging Laboratory at Boston University 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kern KL, Storer TW, Schon K. Cardiorespiratory fitness, hippocampal subfield volumes, and mnemonic discrimination task performance in aging. Hum Brain Mapp. 2021 Mar;42(4):871-892. doi: 10.1002/hbm.25259. Epub 2020 Dec 16.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT02773121
• Other Study ID Numbers: H-34352
• First Posted: May 16, 2016
• 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

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