Physical Activity and Cognition Study

NCT ID: NCT02773121

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-01-17

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

Trainer-guided at-home behavioral intervention

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

Trainer-guided at-home behavioral intervention

Interventions

Physical Activity

Trainer-guided at-home behavioral intervention

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Schon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33325614 (View on PubMed)

Related Links

http://sites.bu.edu/brainplasticity/contact-us/

Brain Plasticity and Neuroimaging Laboratory at Boston University

Other Identifiers

H-34352

Identifier Type: -

Identifier Source: org_study_id