Physical Activity and Cognition Study (CTSI)

Feasibility of Using Physical Activity Monitoring for Enhancing Cognition in Healthy Seniors

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Physical Activity

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	Change in cognitive task performance post-intervention compared to baseline	80-90 minutes
Aerobic Fitness	Change aerobic fitness measured with treadmill test post-intervention	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional fitness: Five Times Sit to Stand	Change in performance in the Five Times Sit to Stand test post-intervention	10 min
Functional fitness: Timed Get Up and Go	Change in performance in the Timed Get Up and Go test post-intervention compared to baseline	10 min
Functional fitness: Flexibility	Change in performance in the Sit and Reach test post-intervention	10 min
Physical activity	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	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait: step and stride time	Change in step and stride time over 12 weeks	12 weeks
Gait: stride time variability	Change in stride time variability over 12 weeks	12 weeks
Gait: gait symmetry	Change in gait symmetry over 12 weeks	12 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Brain Plasticity and Neuroimaging Laboratory at Boston University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Balance; Attention; Body Composition; Memory; Cognition; Walking; Resistance Training; Executive Function; Neuropsychological Tests; Learning; Physical Fitness; Muscle Stretching Exercises; Exercise Test; Flexibility
• Other Study ID Numbers: H-34352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No