Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

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: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Low Intensity Exercise Training 1; Behavioral: Low Intensity Exercise Training 2

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: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Hand grip force	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

Outcome Measure	Measure Description	Time Frame
Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction	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	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	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.	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	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	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	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

• Sponsor: Kessler Foundation
• Collaborators: National Cancer Institute (NCI); Kessler Institute for Rehabilitation
• Investigators: Principal Investigator: Guang Yue, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Fatigue; Breast cancer; Motor imagery; Cancer Treatment; Force
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Asthenia
• Other Study ID 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