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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Completed

Conditions: Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Treatments: Other: Baduanjin exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03162133

20170217

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Exercise group

Experimental group

Description:

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.

Treatment:

Other: Baduanjin exercise

Waiting list Control group

Experimental group

Description:

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.

Treatment:

Other: Baduanjin exercise