Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

NCT ID: NCT01236417

Last Updated: 2012-04-13

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.

Detailed Description

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Conditions

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Breast Cancer Arthralgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise

Subjects will be participating in a home-based flexibility and exercise program

Group Type EXPERIMENTAL

Exercising block

Intervention Type BEHAVIORAL

Exercising for 8 weeks using an elastic band

Interventions

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Exercising block

Exercising for 8 weeks using an elastic band

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
* Patients must complain of mild to moderate arthralgia.
* Ability to understand and sign informed consent.
* Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.

Exclusion Criteria

* Inability to comply with study requirements.
* Metastatic breast cancer.
* Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
* Rheumatoid arthritis.
* History of MI, angina or congestive heart failure.
* Pregnant or lactating females.
* Patients that are high risk for moderate exercise based on ACSM risk classification.
* Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.
* Morbidly obese with BMI ≥ 40
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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I 169310

Identifier Type: -

Identifier Source: org_study_id

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