Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study

Conditions
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Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Intervention / Treatment
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* Other: Baduanjin exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>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. | Other: Baduanjin exercise<br> <br> |
| Experimental: Waiting list Control group<br>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. | Other: Baduanjin exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Quality of Life (QoL) at 3 months | European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30) | at baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline IL-6 at 3 months | proinﬂammatory cytokines interleukin-6 | at baseline and 3 months | 
| Change from Baseline Fatigue at 3 months | Piper fatigue questionnaire | at baseline and 3 months | 
| Change from Baseline sleep quality at 3 months | Pittsburgh sleep quality index, PSQI | at baseline and 3 months | 
| Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months | Brief Pain Inventory-Short Form | at baseline and 3 months | 
| Change from Baseline Symptoms of climacteric syndrome at 3 months | Kupperman Index | at baseline and 3 months | 
| Change from Baseline BMD at 3 months | Bone mineral density | at baseline and 3 months | 
| Change from Baseline BMI at 3 months | Body Mass Index | at baseline and 3 months | 
| Change from Baseline Aerobic Fitness Assessment at 3 months | Six-min walk test (6MWT) | at baseline and 3 months | 
| Change from Baseline Muscle strength test at 3 months | 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) | at baseline and 3 months | 
| Change from Baseline Flexibility test at 3 months | Test of scratching his back and Sit in the chair and reach | at baseline and 3 months | 
| Change from Baseline Balance test at 3 months | stand on one foot | at baseline and 3 months | 
| Change from Baseline TNF-α at 3 months | tumor necrosis factor alpha | at baseline and 3 months | 
| Change from Baseline IL-1β at 3 months | interleukin-1β | at baseline and 3 months | 
| Change from Baseline CRP at 3 months | C-reactive protein | at baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise