- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162133
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
July 26, 2020 updated by: KunWang, Guangdong Provincial People's Hospital
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy:: A Pilot Study
A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months.
All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control.
Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ,BMI,BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment
- Taking an AI (aromatase inhibitors ),and had been receiving an AI for at least 6 months
Exclusion Criteria:
- A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer
- With exercise contraindications:chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse
- Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months
- Women reporting 5 hours or more of vigorous physical activity per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
After completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week.
The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China.
Two senior Baduanjin teachers from Guangzhou Sports University conducted the training.
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Experimental: Waiting list Control group
Participants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise. After their post-assessment they were able to attend the Baduanjin classes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Quality of Life (QoL) at 3 months
Time Frame: at baseline and 3 months
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European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)
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at baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline IL-6 at 3 months
Time Frame: at baseline and 3 months
|
proinflammatory cytokines interleukin-6
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at baseline and 3 months
|
Change from Baseline Fatigue at 3 months
Time Frame: at baseline and 3 months
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Piper fatigue questionnaire
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at baseline and 3 months
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Change from Baseline sleep quality at 3 months
Time Frame: at baseline and 3 months
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Pittsburgh sleep quality index, PSQI
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at baseline and 3 months
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Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
Time Frame: at baseline and 3 months
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Brief Pain Inventory-Short Form
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at baseline and 3 months
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Change from Baseline Symptoms of climacteric syndrome at 3 months
Time Frame: at baseline and 3 months
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Kupperman Index
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at baseline and 3 months
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Change from Baseline BMD at 3 months
Time Frame: at baseline and 3 months
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Bone mineral density
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at baseline and 3 months
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Change from Baseline BMI at 3 months
Time Frame: at baseline and 3 months
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Body Mass Index
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at baseline and 3 months
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Change from Baseline Aerobic Fitness Assessment at 3 months
Time Frame: at baseline and 3 months
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Six-min walk test (6MWT)
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at baseline and 3 months
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Change from Baseline Muscle strength test at 3 months
Time Frame: at baseline and 3 months
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Upper strength: hand grip (measured by a dynamometer; the average of 3 readings) lower limb strength:sit-to-stand (measured as number of reps in a 30-s period)
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at baseline and 3 months
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Change from Baseline Flexibility test at 3 months
Time Frame: at baseline and 3 months
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Test of scratching his back and Sit in the chair and reach
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at baseline and 3 months
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Change from Baseline Balance test at 3 months
Time Frame: at baseline and 3 months
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stand on one foot
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at baseline and 3 months
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Change from Baseline TNF-α at 3 months
Time Frame: at baseline and 3 months
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tumor necrosis factor alpha
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at baseline and 3 months
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Change from Baseline IL-1β at 3 months
Time Frame: at baseline and 3 months
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interleukin-1β
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at baseline and 3 months
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Change from Baseline CRP at 3 months
Time Frame: at baseline and 3 months
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C-reactive protein
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at baseline and 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kun Wang, Guangdong Provincial People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2016
Primary Completion (Actual)
November 10, 2017
Study Completion (Actual)
November 10, 2018
Study Registration Dates
First Submitted
May 12, 2017
First Submitted That Met QC Criteria
May 19, 2017
First Posted (Actual)
May 22, 2017
Study Record Updates
Last Update Posted (Actual)
July 29, 2020
Last Update Submitted That Met QC Criteria
July 26, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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China Medical University HospitalCompletedBreast Cancer | Knee Pain | Yoga | Aromatase InhibitorTaiwan
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