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

Primary Purpose

Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin exercise
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy focused on measuring Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise group

Waiting list Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Quality of Life (QoL) at 3 months
European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)

Secondary Outcome Measures

Change from Baseline IL-6 at 3 months
proinflammatory cytokines interleukin-6
Change from Baseline Fatigue at 3 months
Piper fatigue questionnaire
Change from Baseline sleep quality at 3 months
Pittsburgh sleep quality index, PSQI
Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
Brief Pain Inventory-Short Form
Change from Baseline Symptoms of climacteric syndrome at 3 months
Kupperman Index
Change from Baseline BMD at 3 months
Bone mineral density
Change from Baseline BMI at 3 months
Body Mass Index
Change from Baseline Aerobic Fitness Assessment at 3 months
Six-min walk test (6MWT)
Change from Baseline Muscle strength test at 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 Flexibility test at 3 months
Test of scratching his back and Sit in the chair and reach
Change from Baseline Balance test at 3 months
stand on one foot
Change from Baseline TNF-α at 3 months
tumor necrosis factor alpha
Change from Baseline IL-1β at 3 months
interleukin-1β
Change from Baseline CRP at 3 months
C-reactive protein

Full Information

First Posted
May 12, 2017
Last Updated
July 26, 2020
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Guangzhou Sport University
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1. Study Identification

Unique Protocol Identification Number
NCT03162133
Brief Title
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Official Title
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Guangzhou Sport University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Keywords
Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm 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.
Arm Title
Waiting list Control group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Baduanjin exercise
Primary Outcome Measure Information:
Title
Change from Baseline Quality of Life (QoL) at 3 months
Description
European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)
Time Frame
at baseline and 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline IL-6 at 3 months
Description
proinflammatory cytokines interleukin-6
Time Frame
at baseline and 3 months
Title
Change from Baseline Fatigue at 3 months
Description
Piper fatigue questionnaire
Time Frame
at baseline and 3 months
Title
Change from Baseline sleep quality at 3 months
Description
Pittsburgh sleep quality index, PSQI
Time Frame
at baseline and 3 months
Title
Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
Description
Brief Pain Inventory-Short Form
Time Frame
at baseline and 3 months
Title
Change from Baseline Symptoms of climacteric syndrome at 3 months
Description
Kupperman Index
Time Frame
at baseline and 3 months
Title
Change from Baseline BMD at 3 months
Description
Bone mineral density
Time Frame
at baseline and 3 months
Title
Change from Baseline BMI at 3 months
Description
Body Mass Index
Time Frame
at baseline and 3 months
Title
Change from Baseline Aerobic Fitness Assessment at 3 months
Description
Six-min walk test (6MWT)
Time Frame
at baseline and 3 months
Title
Change from Baseline Muscle strength test at 3 months
Description
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)
Time Frame
at baseline and 3 months
Title
Change from Baseline Flexibility test at 3 months
Description
Test of scratching his back and Sit in the chair and reach
Time Frame
at baseline and 3 months
Title
Change from Baseline Balance test at 3 months
Description
stand on one foot
Time Frame
at baseline and 3 months
Title
Change from Baseline TNF-α at 3 months
Description
tumor necrosis factor alpha
Time Frame
at baseline and 3 months
Title
Change from Baseline IL-1β at 3 months
Description
interleukin-1β
Time Frame
at baseline and 3 months
Title
Change from Baseline CRP at 3 months
Description
C-reactive protein
Time Frame
at baseline and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Wang
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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