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

Cognitive Impairment, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498195
• Other study ID #: SMUIRB#19-013
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: December 6, 2019

Study information

• Verified date: July 2020
• Source: Samuel Merritt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 6, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• increased exercise and physical activity
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.

Locations

Country	Name	City	State
United States	Sutter Medical Neuroscience	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Merritt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning.	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.	12 weeks