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Breast CancerMATCHNCT04255225

Making Activity Time for Cognitive Health

A study testing Walking for 10 minutes, Walking for 20 minutes and Walking for 30 minutes in people with Breast Cancer and Cancer-related Problem/Condition, run by University of Illinois at Urbana-Champaign.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Walking for 10 minutes, Walking for 20 minutes and Walking for 30 minutes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2016to Apr 2017
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

Official title: 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.

Being tested
Walking for 10 minutes, Walking for 20 minutes, Walking for 30 minutes
Medical subject headings
Breast Neoplasms, Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking for 10 minutesBehavioural

    Participants will walk on a treadmill for 10 minutes at a moderate intensity.

  • Walking for 20 minutesBehavioural

    Participants will walk on a treadmill for 20 minutes at a moderate intensity.

  • Walking for 30 minutesBehavioural

    Participants will walk on a treadmill for 30 minutes at a moderate intensity.

Study groups in NCT04255225
Study groupRoleWhat they receive
10-minute Treadmill WalkingExperimentalAll 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.
Receives: Behavioral: Walking for 10 minutes
20-minute Treadmill WalkingExperimentalAll 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.
Receives: Behavioral: Walking for 20 minutes
30-minute Treadmill WalkingExperimentalAll 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.
Receives: Behavioral: Walking for 30 minutes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in working memory by walking as a function of walking duration (10, 20 or 30 minutes)

    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.

    Measured: 1 year

  2. Change in attention by walking as a function of walking duration (10, 20 or 30 minutes)

    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.

    Measured: 1 year

  3. Change in cognitive flexibility by walking as a function of walking duration (10, 20 or 30 minutes)

    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.

    Measured: 1 year

  4. Change in processing speed by walking as a function of walking duration (10, 20 or 30 minutes)

    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.

    Measured: 1 year

Secondary outcomes (4)

  1. 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

    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.

    Measured: 1 year

  2. 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

    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.

    Measured: 1 year

  3. 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

    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.

    Measured: 1 year

  4. Change from baseline in anxiety levels after one bout of exercise as assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire.

    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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study startSep 2016
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255225
Sponsor's protocol ID
UIUC_IRB_16912
Acronym
MATCH
Status last verified
Feb 2020
First submitted
29 Jan 2020
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salerno EA, Rowland K, Hillman CH, Trinh L, Kramer AF, McAuley E. Dose-Response Effects of Acute Aerobic Exercise Duration on Cognitive Function in Patients With Breast Cancer: A Randomized Crossover Trial. Front Psychol. 2020 Jul 14;11:1500. doi: 10.3389/fpsyg.2020.01500. eCollection 2020.

    PubMed 32760319

Questions about this trial

What is this clinical trial studying?

A study testing Walking for 10 minutes, Walking for 20 minutes and Walking for 30 minutes in people with Breast Cancer and Cancer-related Problem/Condition, run by University of Illinois at Urbana-Champaign.

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 11 inclusion and 12 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in working memory by walking as a function of walking duration (10, 20 or 30 minutes) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255225, which also lists 1 linked publication.

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 11 Feb 2020.

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