Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

NCT02844504 | Completed

• 2 other identifiers: R-849-145R01CA189665-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Fatigue; Breast cancer; Force; Motor imagery; Cancer Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction

  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

  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

  Pretest (before training), Posttest (immediately after end of training)

• Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.

  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

  Pretest (before training), Posttest (immediately after end of training)

Study Arms (3)

Low Intensity Exercise Training 1

EXPERIMENTAL

Cancer survivors will receive low intensity handgrip exercise training.

Behavioral: Low Intensity Exercise Training 1

Low Intensity Exercise Training 2

EXPERIMENTAL

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

Behavioral: Low Intensity Exercise Training 2

Control

NO INTERVENTION

This group will receive no training.

Interventions

Low Intensity Exercise Training 1 BEHAVIORAL

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 1

Low Intensity Exercise Training 2 BEHAVIORAL

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)

Low Intensity Exercise Training 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• National Cancer Institute (NCI): collaborator
• Kessler Institute for Rehabilitation: collaborator

Study Sites (2)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guang Yue, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 26, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)