Clinical trial NCT02844504: Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
Official title: Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Fatigue
Breast cancer
Force
Motor imagery
Cancer Treatment
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Kessler Institute for Rehabilitation
First posted: 2016-07-26
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hand grip force
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Secondary outcomes:
measure: Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
measure: Pre to Post changes in EMG amplitude at maximum handgrip contraction
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
measure: Pre to Post changes in Brain activity during maximum handgrip contraction
timeFrame: Pretest (before training), Posttest (immediately after end of training)
measure: Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
measure: EEG Brain connectivity during low intensity handgrip muscle contraction
timeFrame: Pretest (before training), Posttest (immediately after end of training)
measure: Fatigue sustained handgrip contraction task duration
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
measure: functional brain to muscle coupling during fatigue
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Guang Yue, PhD
role: PRINCIPAL_INVESTIGATOR
References: