Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2013-03-31

Brief Summary

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RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.

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Detailed Description

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OBJECTIVES:

Primary

* To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.

OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.

* Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
* Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

Conditions

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Breast Cancer Depression Fatigue Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm I: Yoga Therapy

Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.

Group Type EXPERIMENTAL

Yoga Therapy

Intervention Type PROCEDURE

Patients will undergo yoga therapy

Arm II: Wait-List

Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga Therapy

Patients will undergo yoga therapy

Intervention Type PROCEDURE

Other Intervention Names

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Yoga

Eligibility Criteria

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Inclusion Criteria

* No inflammatory breast cancer

PATIENT CHARACTERISTICS:

* Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of \< 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
* Physically able to fully participate in yoga intervention

Exclusion Criteria

* Inability to comfortably get up and down from the floor 2-3 times in a session
* Breathing problems requiring use of oxygen
* Problems walking without a cane or walker assistance
* Prior knee or hip replacement with limited movement in the joint
* Inability to comfortably lie on the stomach
* Alcohol, or drug abuse
* Diagnosis of any of the following conditions:

* Diabetes
* Chronic obstructive pulmonary disease
* Uncontrolled hypertension
* Evidence of liver or kidney failure
* Symptomatic ischemic heart disease
* Significant visual or auditory problems
* Mental disorder or cognitive impairment
* Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
* Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
* History of breast or any other cancer, except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No regular use of medications with major immunological consequences (e.g., steroids)

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No