Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
yoga
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- breast cancer with stage1 or stage2, Sedentary life style, no orthopaedic disease and medical disease
Exclusion criteria
- recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
yoga training
control
Arm Description
Yoga training
no yoga training
Outcomes
Primary Outcome Measures
change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 13th weeks
Secondary Outcome Measures
change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 25th weeks
Full Information
NCT ID
NCT01743573
First Posted
November 20, 2012
Last Updated
December 5, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01743573
Brief Title
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
Official Title
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study wants to prove that Yoga Training can improve physical Fitness, immunity, and quality of Life of in Breast Cancer Survivors. In summary, our findings show potential benefits of yoga for people with cancer in improvements of psychological health. Because of the small number of studies having been conducted and the methodological limitations, the results should be regarded as preliminary and treated with caution. Our preliminary findings also provide practitioners with important information that yoga may be a possible adjunctive therapy for cancer patients to help manage psychological distress and to improve quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
yoga training
Arm Type
Experimental
Arm Description
Yoga training
Arm Title
control
Arm Type
No Intervention
Arm Description
no yoga training
Intervention Type
Other
Intervention Name(s)
yoga
Primary Outcome Measure Information:
Title
change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 13th weeks
Time Frame
13th week
Secondary Outcome Measure Information:
Title
change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 25th weeks
Time Frame
25th week
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
breast cancer with stage1 or stage2, Sedentary life style, no orthopaedic disease and medical disease
Exclusion criteria
recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jau-Yih Tsauo, PhD
Email
jytsauo@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsauo Jau-Yih, Ph.D
Phone
+886-2-33662180
Email
jytsauo@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
We'll reach out to this number within 24 hrs