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Completed

NCT Number: NCT02773121

Physical Activity and Cognition Study

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Trainer-guided at-home behavioral intervention

Primary outcomes

  1. Cognition

    Time frame: 80-90 minutes

    Change in cognitive task performance post-intervention compared to baseline

  2. Aerobic Fitness

    Time frame: 30 minutes

    Change aerobic fitness measured with treadmill test post-intervention

Secondary outcomes

  1. Functional fitness: Five Times Sit to Stand

    Time frame: 10 min

    Change in performance in the Five Times Sit to Stand test post-intervention

  2. Functional fitness: Timed Get Up and Go

    Time frame: 10 min

    Change in performance in the Timed Get Up and Go test post-intervention compared to baseline

  3. Functional fitness: Flexibility

    Time frame: 10 min

    Change in performance in the Sit and Reach test post-intervention

  4. Physical activity

    Time frame: 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 outcomes

  1. Gait: step and stride time

    Time frame: 12 weeks

    Change in step and stride time over 12 weeks

  2. Gait: stride time variability

    Time frame: 12 weeks

    Change in stride time variability over 12 weeks

  3. Gait: gait symmetry

    Time frame: 12 weeks

    Change in gait symmetry over 12 weeks

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

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

Acronym: CTSI

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 16, 2016
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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