Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

Breast Cancer Clinical Trial

Official title:

Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844504
• Other study ID #: R-849-14
• Secondary ID: 5R01CA189665-02
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: September 2020

Study information

• Verified date: October 2020
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Kessler Foundation	Kessler Institute for Rehabilitation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)