Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

Kessler Foundation

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Low Intensity Exercise Training 1; Behavioral: Low Intensity Exercise Training 2

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02844504

5R01CA189665-02 (U.S. NIH Grant/Contract)

R-849-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

23 participants in 3 patient groups

Low Intensity Exercise Training 1

Experimental group

Description:

Cancer survivors will receive low intensity handgrip exercise training.

Treatment:

Behavioral: Low Intensity Exercise Training 1

Low Intensity Exercise Training 2

Experimental group

Description:

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

Treatment:

Behavioral: Low Intensity Exercise Training 2

Control

No Intervention group

Description:

This group will receive no training.