- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255225
Making Activity Time for Cognitive Health (MATCH)
February 7, 2020 updated by: Edward McAuley, University of Illinois at Urbana-Champaign
Making Activity Time for Cognitive Health (MATCH)
Approximately 75% of cancer survivors experience some degree of cognitive deficit throughout their cancer experience, with upwards of one third of breast cancer survivors reporting impairments up to a decade after treatment.
Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life.
Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function.
The investigators recently reported on the beneficial effects of acute exercise, or single sessions of physical activity, on processing speed and spatial working memory in breast cancer survivors, suggesting that acute bouts of physical activity may mitigate select domains of CRCI.
Specifically, survivors in this study demonstrated faster processing speed, and trended towards faster and more accurate spatial working memory, after thirty minutes of moderate-intensity walking compared to seated rest.
But half an hour of walking may be challenging to certain subgroups of survivors, particularly those who are deconditioned or with significant barriers to longer walks.
With a renewed focus on un-bouted physical activity and avoiding inactivity during survivorship, it is important to better understand the dose or volume of exercise responsible for providing breast cancer survivors with the greatest cognitive benefits.
The investigators examined the effects of varying durations of exercise (e.g., 10, 20 and 30 minutes) on cognitive function in breast cancer survivors to identify the optimal length of acute exercise.
Findings from this study will inform new guidelines for acute exercise after cancer.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women over the age of 18
- diagnosis of breast cancer
- no longer undergoing treatment
- fluent in English
- no history of dementia or organic brain syndrome
- not currently pregnant
- able to walk unassisted
- no health reasons that would prevent ability to exercise
- not currently enrolled in another exercise research study
- reported trouble with memory/concentration
- physician's consent
Exclusion Criteria:
- male
- no diagnosis of breast cancer
- under 18 years of age
- currently undergoing treatment for breast cancer
- inability to communicate in English
- history of dementia or organic brain syndrome
- pregnant
- unable to walk unassisted
- other health reasons that may prevent ability to exercise
- enrolled in another exercise research study
- no reported trouble with memory or concentration
- non-consent of physician
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 10-minute Treadmill Walking
All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session.
Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
|
Participants will walk on a treadmill for 10 minutes at a moderate intensity.
|
|
Experimental: 20-minute Treadmill Walking
All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session.
Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
|
Participants will walk on a treadmill for 20 minutes at a moderate intensity.
|
|
Experimental: 30-minute Treadmill Walking
All participants will walk on the treadmill and perform a battery of cognitive tasks immediately prior and immediately after the walking session.
Participants will be randomized the length of time spent walking on the treadmill: 10, 20 or 30 minutes.
|
Participants will walk on a treadmill for 30 minutes at a moderate intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in working memory by walking as a function of walking duration (10, 20 or 30 minutes)
Time Frame: 1 year
|
All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly.
Prior to each session, participants will complete a cognitive battery consisting of a working memory task (Spatial Working Memory domain).
They will then complete the same cognitive battery immediately after the session.
Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
|
1 year
|
|
Change in attention by walking as a function of walking duration (10, 20 or 30 minutes)
Time Frame: 1 year
|
All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly.
Prior to each session, participants will complete a cognitive battery consisting of an attention task (Flanker task).
They will then complete the same cognitive battery immediately after the session.
Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
|
1 year
|
|
Change in cognitive flexibility by walking as a function of walking duration (10, 20 or 30 minutes)
Time Frame: 1 year
|
All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly.
Prior to each session, participants will complete a cognitive battery consisting of a cognitive flexibility task (Task Switching Paradigm).
They will then complete the same cognitive battery immediately after the session.
Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
|
1 year
|
|
Change in processing speed by walking as a function of walking duration (10, 20 or 30 minutes)
Time Frame: 1 year
|
All participants will complete both a walking and a sitting session, but the duration of these sessions will be determined randomly.
Prior to each session, participants will complete a cognitive battery consisting of a processing speed task (Letter Comparison task).
They will then complete the same cognitive battery immediately after the session.
Accuracy ranges from 0-100% and reaction time ranges from 0-5000 milliseconds.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lifestyle physical activity as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
Time Frame: 1 year
|
Investigators are interested in determining what lifestyle factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise.
Lifestyle physical activity will be measured via accelerometer in units of average minutes per day.
Higher values indicate greater levels of lifestyle physical activity.
|
1 year
|
|
Mental health as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
Time Frame: 1 year
|
Investigators are interested in determining what mental health factors are associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise.
Mental health factors of interest are anxiety and depression as measured via the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Scores range from 0-21 with higher scores indicating increased anxiety and depression.
|
1 year
|
|
Body mass index as a predictor of change in cognitive function (executive function domains: working memory, attention/inhibition/cognitive flexibility and processing speed) after acute exercise
Time Frame: 1 year
|
Investigators are interested in determining is body mass index associated with significant change in cognition (processing speed, working memory, attention/inhibition, cognitive flexibility) from pre- to post-acute exercise.
Body mass index will be measured using the standard kilograms/meters^2.
Increased body mass index indicates worsened health.
|
1 year
|
|
Change from baseline in anxiety levels after one bout of exercise as assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Time Frame: 30 minutes
|
Participants will complete a short anxiety questionnaire before and after a 30 minute bout of aerobic exercise.
The investigators will then compare the pre- and post- values to examine if any changes are present.
Scores on the HADS range from 0-21 with higher scores indicating increased anxiety and depression.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
February 2, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UIUC_IRB_16912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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