Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness

NCT ID: NCT02844504

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Intensity Exercise Training 1

Cancer survivors will receive low intensity handgrip exercise training.

Group Type EXPERIMENTAL

Low Intensity Exercise Training 1

Intervention Type 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 2

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

Group Type EXPERIMENTAL

Low Intensity Exercise Training 2

Intervention Type 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)

Control

This group will receive no training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Kessler Institute for Rehabilitation

INDUSTRY

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guang Yue, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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5R01CA189665-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R-849-14

Identifier Type: -

Identifier Source: org_study_id

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