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
- Interventions
- Other: Baduanjin exercise
- 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
- Arm && Interventions
Group Intervention Description Exercise group Baduanjin exercise 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. Waiting list Control group Baduanjin exercise 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.
- 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 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 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 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