Clinical trial NCT02773121: Physical Activity and Cognition Study
Official title: Feasibility of Using Physical Activity Monitoring for Enhancing Cognition in Healthy Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: 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
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Cognition
timeFrame: 80-90 minutes
measure: Aerobic Fitness
timeFrame: 30 minutes
Secondary outcomes:
measure: Functional fitness: Five Times Sit to Stand
timeFrame: 10 min
measure: Functional fitness: Timed Get Up and Go
timeFrame: 10 min
measure: Functional fitness: Flexibility
timeFrame: 10 min
measure: Physical activity
timeFrame: 12 weeks
Other outcomes:
measure: Gait: step and stride time
timeFrame: 12 weeks
measure: Gait: stride time variability
timeFrame: 12 weeks
measure: Gait: gait symmetry
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Karin Schon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.