Physical Activity and Cognition Study

Aging Clinical Trial

— CTSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773121
• Other study ID #: H-34352
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 17, 2020

Study information

• Verified date: April 2020
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Physical Activity
Trainer-guided at-home behavioral intervention

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait: step and stride time	Change in step and stride time over 12 weeks	12 weeks
Other	Gait: stride time variability	Change in stride time variability over 12 weeks	12 weeks
Other	Gait: gait symmetry	Change in gait symmetry over 12 weeks	12 weeks
Primary	Cognition	Change in cognitive task performance post-intervention compared to baseline	80-90 minutes
Primary	Aerobic Fitness	Change aerobic fitness measured with treadmill test post-intervention	30 minutes
Secondary	Functional fitness: Five Times Sit to Stand	Change in performance in the Five Times Sit to Stand test post-intervention	10 min
Secondary	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
Secondary	Functional fitness: Flexibility	Change in performance in the Sit and Reach test post-intervention	10 min
Secondary	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

External Links

•   Brain Plasticity and Neuroimaging Laboratory at Boston University