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

July 26, 2020 updated by: KunWang, Guangdong Provincial People's Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kun Wang, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 10, 2018

Study Registration Dates

First Submitted

May 12, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 26, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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