Physical Activity and Cognition Study
CTSI
Feasibility of Using Physical Activity Monitoring for Enhancing Cognition in Healthy Seniors
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedApril 21, 2020
April 1, 2020
2.9 years
May 11, 2016
April 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Functional fitness: Five Times Sit to Stand
10 min
Functional fitness: Timed Get Up and Go
10 min
Functional fitness: Flexibility
10 min
Physical activity
12 weeks
Other Outcomes (3)
Gait: step and stride time
12 weeks
Gait: stride time variability
12 weeks
Gait: gait symmetry
12 weeks
Study Arms (2)
Physical activity monitoring
EXPERIMENTALParticipants 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.
Flexibility and balance
ACTIVE COMPARATORParticipants 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.
Interventions
Trainer-guided at-home behavioral intervention
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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:
- learning disability
- neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
- 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:
- 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.)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Related Publications (1)
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.
PMID: 33325614DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Schon, Ph.D.
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 16, 2016
Study Start
March 1, 2017
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
April 21, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share