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OpenTrials
Completed

NCT Number: NCT04498195

Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project

Background: Many studies suggest physical activity reduces risk of dementia and improves global cognitive function in individuals with mild cognitive impairment (MCI). Using commercial wearable technology to measure daily steps is feasible in this population.

Objectives: The purpose of this pilot study was to explore whether 12 weeks of increased physical activity improved cognitive function in individuals with MCI. A wearable activity tracker was used to measure participants' daily steps as a quantifiable measure of daily activity level.

Design: This was a one-group pretest-posttest study.

Setting: Established memory clinic patients within a neurology department in Northern California during 2019.

Participants: 17 enrolled and 14 included for data analysis. There were 7 females and 7 males whose mean age was 76.21 (SD 2.69). 12 participants were White, which reflected the clinic population.

Intervention: Participants were asked to wear an activity tracker for approximately 12 hours a day for 12 weeks and to increase their physical activity as much as possible. They were provided twice a month telephone support.

Measurements: The Montreal Cognitive Assessment (MoCA) was used to measure pretest-posttest cognitive function. Timed Up and Go (TUG) was used to assess fall risk at enrollment. Cumulative step count for the study period was measured with an activity tracker.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sutter Medical Neuroscience

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants had a score of 0.5 on the Clinical Dementia Rating and are on a stable medication regimen for 3 months prior to enrollment.

Exclusion criteria

  • a diagnosis of dementia; receiving chemotherapy; unstable chronic diseases; surgery with general anesthesia in the prior 3 months; MRI-confirmed brain damage from trauma, stroke, or other neurological disorder; a myocardial infarction < 1 year; a serious or non-healing wound, ulcer, or bone fracture; TUG ≥ 12 seconds; MoCA score >26 or <16; already using a wearable activity tracker; lacked access to the internet; or non-English speaking.

Treatment and study plan

increased exercise and physical activity

Behavioral

Participants were encouraged to increase physical activity for 12-week study duration and wear an activity tracker for a minimum of 12 hours a day.

Primary outcomes

  1. Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning.

    Time frame: 12 weeks

    participants would wear an activity tracker and increase physical activity as much as possible within their comfort level. Participants will be tested for pretest MoCA for cognitive function and TUG for fall risk. After 12 weeks, participants will be tested for posttest MoCA to find any cognitive function change.

Sponsors and collaborators

Lead sponsor

Samuel Merritt University

Other

Registry information

Official study title

Effect of a Walking Intervention on Cognitive Function in Individuals With Mild Cognitive Impairment: A Knowledge Translation to Practice Pilot Project

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2020
Registry last updated
Aug 4, 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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