Cognitive Impairment, MildNCT04498195
Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project
A study testing increased exercise and physical activity in people with Cognitive Impairment, Mild, run by Samuel Merritt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Mild
- What is being tested?
- increased exercise and physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sutter Medical Neuroscience
Sacramento, California, 95816
About this study
Official title: Effect of a Walking Intervention on Cognitive Function in Individuals With Mild Cognitive Impairment: A Knowledge Translation to Practice 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.
Read more
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.
- Conditions
- Cognitive Impairment, Mild
- Being tested
- increased exercise and physical activity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased exercise and physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Increase physical activity and exercise | Experimental | Not described Receives: Behavioral: increased exercise and physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start7 Jan 2019
- Primary completion31 Oct 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Merritt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gasong Yun Nickerson, Samuel Merritt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498195
- Sponsor's protocol ID
- SMUIRB#19-013
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Walking Intervention on Cognitive Function in Individuals With Mild Cognitive Impairment: A Knowledge Translation to Practice Pilot Project
- ClinicalTrials.gov ID
- NCT04498195
- Acronym / sponsor ID
- SMUIRB#19-013
- Conditions
- Cognitive Impairment, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Samuel Merritt UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Increase physical activity and exercise | Experimental | Behavioral: increased exercise and physical activity |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| increased exercise and physical activityParticipants were encouraged to increase physical activity for 12-week study duration and wear an activity tracker for a minimum of 12 hours a day. | Behavioural | Increase physical activity and exercise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increased exercise and physical activity in people with Cognitive Impairment, Mild, run by Samuel Merritt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.