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Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236417
First Posted: November 8, 2010
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
November 5, 2010
November 8, 2010
April 13, 2012
March 2010
March 2012   (Final data collection date for primary outcome measure)
Effects of exercise [ Time Frame: Length of study ]
To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.
Same as current
Complete list of historical versions of study NCT01236417 on ClinicalTrials.gov Archive Site
Feasibility of Multi-institutional study [ Time Frame: Length of the study ]
To perform a pilot to access the feasibility of a multi-institutional approach
Same as current
Not Provided
Not Provided
 
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Breast Cancer
  • Arthralgia
Behavioral: Exercising block
Exercising for 8 weeks using an elastic band
Experimental: Exercise
Subjects will be participating in a home-based flexibility and exercise program
Intervention: Behavioral: Exercising block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01236417
I 169310
Yes
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Tracy O'Connor, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP