Physical Activity and Cognition Study (CTSI)

Boston University

Status: Completed

Conditions: Aging

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02773121

H-34352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Physical activity monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity

Flexibility and balance

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity