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

NCT ID: NCT03162133

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-10
• Study Completion Date: 2018-11-10

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.

Conditions

Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Baduanjin exercise

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Baduanjin exercise

Intervention Type: OTHER

Interventions

Baduanjin exercise

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Sport University

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

KunWang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kun Wang

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

20170217

Identifier Type: -

Identifier Source: org_study_id