Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04255225
Other study ID # UIUC_IRB_16912
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date April 2017

Study information

Verified date February 2020
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Walking for 10 minutes
Participants will walk on a treadmill for 10 minutes at a moderate intensity.
Walking for 20 minutes
Participants will walk on a treadmill for 20 minutes at a moderate intensity.
Walking for 30 minutes
Participants will walk on a treadmill for 30 minutes at a moderate intensity.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Primary 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. 1 year
Primary 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. 1 year
Primary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary 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. 30 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A