Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
- Conditions
- Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
- Registration Number
- NCT03162133
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline Quality of Life (QoL) at 3 months at baseline and 3 months European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)
- Secondary Outcome Measures
Name Time Method Change from Baseline BMI at 3 months at baseline and 3 months Body Mass Index
Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months at baseline and 3 months Brief Pain Inventory-Short Form
Change from Baseline BMD at 3 months at baseline and 3 months Bone mineral density
Change from Baseline Flexibility test at 3 months at baseline and 3 months Test of scratching his back and Sit in the chair and reach
Change from Baseline IL-1β at 3 months at baseline and 3 months interleukin-1β
Change from Baseline CRP at 3 months at baseline and 3 months C-reactive protein
Change from Baseline IL-6 at 3 months at baseline and 3 months proinflammatory cytokines interleukin-6
Change from Baseline Fatigue at 3 months at baseline and 3 months Piper fatigue questionnaire
Change from Baseline sleep quality at 3 months at baseline and 3 months Pittsburgh sleep quality index, PSQI
Change from Baseline Symptoms of climacteric syndrome at 3 months at baseline and 3 months Kupperman Index
Change from Baseline Aerobic Fitness Assessment at 3 months at baseline and 3 months Six-min walk test (6MWT)
Change from Baseline Muscle strength test at 3 months at baseline and 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)
Change from Baseline Balance test at 3 months at baseline and 3 months stand on one foot
Change from Baseline TNF-α at 3 months at baseline and 3 months tumor necrosis factor alpha
Trial Locations
- Locations (1)
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong General Hospital🇨🇳Guangzhou, Guangdong, China