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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Walking for 10 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.
Behavioral: Walking for 20 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.
Behavioral: Walking for 30 minutes
Participants will walk on a treadmill for 30 minutes at a moderate intensity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings