Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

October 1, 2020 updated by: Kessler Foundation
Breast cancer patients often suffer from long-term physical symptoms of weakness. In this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. Using brain imaging, the study will also investigate changes in brain structure, and muscle activity associated with handgrip.

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.

Detailed Description

Participants will be randomized to either a no treatment group or one of two low intensity 6-week exercise training. Outcomes will be measured at baseline, post-intervention and 4 weeks post intervention.

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.
23

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female aged 40-75 yrs
  • Right handed, as determined by the Edinburgh Inventory (Oldfield, 1971)
  • Proficient in English
  • Must be available for the familiarization, and testing sessions

Exclusion Criteria:

  • Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
  • Significant cognitive impairments as defined by a score <28 in the Folstein Mini-Mental Screening Examination (MMSE, Folstein et al .1975).
  • Participated in any type of motor imagery or strength training program in the last 5 years, or plan to start any motor imagery or physical strength training program for the 3 months duration of the study
  • Neurological, psychiatric, musculoskeletal or other types of disorder that may affect participants sensorimotor function and cognitive abilities
  • Current medication believed to affect cognitive/psychomotor function (i.e., opioid, analgesics, anxiolytics or antidepressants)
  • History of alcohol, smoking, and drug abuse
  • Any contraindication for MRI

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Low Intensity Exercise Training 1
Cancer survivors will receive low intensity handgrip exercise training.
Behavioral: Low Intensity Exercise Training 1
Subjects will perform handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
Experimental: Low Intensity Exercise Training 2
Cancer survivors will receive low intensity handgrip exercise training different than other arm.
Behavioral: Low Intensity Exercise Training 2
Subjects will perform a different handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
No Intervention: Control
This group will receive no training.

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
Hand grip force
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Primary outcome will be used to compare pre to post change in maximum force contraction at the end of the 6-week intervention between groups.Similar comparison will be done between retention test (4 weeks after training) and posttest (immediately after training).
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)

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
Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Functional brain to muscle coupling will be measured by computing the EMG-EEG coherence before training, after training, and 4 weeks after end of intervention. Values will be compared between groups.
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in EMG amplitude at maximum handgrip contraction
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
EMG of the right arm muscles will be assessed during maximum handgrip contraction before training, after training, and 4 weeks after end of intervention. Values will be compared between groups.
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in Brain activity during maximum handgrip contraction
Time Frame: Pretest (before training), Posttest (immediately after end of training)
functional magnetic resonance imaging will used to measure brain activity when subject performs maximum muscle handgrip contraction before training, after training. Values will be compared between groups.
Pretest (before training), Posttest (immediately after end of training)
Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Corticomuscular coherence between EEG signal from contralateral motor region and EMG signal from handgrip muscles will be computed while subjects perform handgrip contraction at 20% of their maximum force.Group x Time interaction will be measured.
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
EEG Brain connectivity during low intensity handgrip muscle contraction
Time Frame: Pretest (before training), Posttest (immediately after end of training)
functional connectivity within the brain networks will be studied while subjects perform 20% of their maximum handgrip contraction. Group x Time interaction will be measured.
Pretest (before training), Posttest (immediately after end of training)
Fatigue sustained handgrip contraction task duration
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Subjects will perform a sustained handgrip contraction task at 20% maximal force.The task duration (a measure of endurance) will be measured for each subject in the three groups, before and after training, and after 4 weeks of end of intervention. Group x Time interaction will be measured.
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
functional brain to muscle coupling during fatigue
Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
EMG-EEG coherence will be studied when subjects get fatigue after performing a sustained muscle contraction task at 20% maximal force. Group x Time interaction will be measured.
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)

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.
Kessler Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Kessler Institute for Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guang Yue, PhD, Kessler Foundation

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.
May 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.
September 1, 2020

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.
September 1, 2020

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).
June 23, 2016

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.
July 21, 2016

First Posted (Estimate)

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.
July 26, 2016

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.
October 5, 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.
October 1, 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.
October 1, 2020

More Information

Terms related to this study

Keywords

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.
  • R-849-14
  • 5R01CA189665-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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