CTSI: Physical Activity and Cognition Study

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT02773121

Collaborator

(none)

Enrollment

Location

Arms

34.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Mar 1, 2017

Actual Primary Completion Date :

Jan 17, 2020

Actual Study Completion Date :

Jan 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

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

Cognition [80-90 minutes]
Change in cognitive task performance post-intervention compared to baseline
Aerobic Fitness [30 minutes]
Change aerobic fitness measured with treadmill test post-intervention

Secondary Outcome Measures

Functional fitness: Five Times Sit to Stand [10 min]
Change in performance in the Five Times Sit to Stand test post-intervention
Functional fitness: Timed Get Up and Go [10 min]
Change in performance in the Timed Get Up and Go test post-intervention compared to baseline
Functional fitness: Flexibility [10 min]
Change in performance in the Sit and Reach test post-intervention
Physical activity [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

Gait: step and stride time [12 weeks]
Change in step and stride time over 12 weeks
Gait: stride time variability [12 weeks]
Change in stride time variability over 12 weeks
Gait: gait symmetry [12 weeks]
Change in gait symmetry over 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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.)
diagnosis of electrolyte disorder or abnormality
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