NCT04498195

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

July 28, 2020

Last Update Submit

July 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Increase physical activity and exercise

EXPERIMENTAL
Behavioral: increased exercise and physical activity

Interventions

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.

Increase physical activity and exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutter Medical Neuroscience

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DNP graduate

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 4, 2020

Study Start

January 7, 2019

Primary Completion

October 31, 2019

Study Completion

December 6, 2019

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations