search
Back to results

Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Intensity Exercise Training 1
Low Intensity Exercise Training 2
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Fatigue, Breast cancer, Force, Motor imagery, Cancer Treatment

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kessler Foundation
  • Kessler Institute for Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Low Intensity Exercise Training 1

Low Intensity Exercise Training 2

Control

Arm Description

Cancer survivors will receive low intensity handgrip exercise training.

Cancer survivors will receive low intensity handgrip exercise training different than other arm.

This group will receive no training.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 23, 2016
Last Updated
October 1, 2020
Sponsor
Kessler Foundation
Collaborators
National Cancer Institute (NCI), Kessler Institute for Rehabilitation
search

1. Study Identification

Unique Protocol Identification Number
NCT02844504
Brief Title
Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
Official Title
Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
National Cancer Institute (NCI), Kessler Institute for Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Fatigue, Breast cancer, Force, Motor imagery, Cancer Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Intensity Exercise Training 1
Arm Type
Experimental
Arm Description
Cancer survivors will receive low intensity handgrip exercise training.
Arm Title
Low Intensity Exercise Training 2
Arm Type
Experimental
Arm Description
Cancer survivors will receive low intensity handgrip exercise training different than other arm.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive no training.
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Exercise Training 1
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Exercise Training 2
Intervention Description
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)
Primary Outcome Measure Information:
Title
Hand grip force
Description
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).
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Secondary Outcome Measure Information:
Title
Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Title
Pre to Post changes in EMG amplitude at maximum handgrip contraction
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Title
Pre to Post changes in Brain activity during maximum handgrip contraction
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training)
Title
Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Title
EEG Brain connectivity during low intensity handgrip muscle contraction
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training)
Title
Fatigue sustained handgrip contraction task duration
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Title
functional brain to muscle coupling during fatigue
Description
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.
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Yue, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

We'll reach out to this number within 24 hrs