Skip to main content
OpenTrials
Completed

NCT Number: NCT03162133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baduanjin Exercise

Other

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change from Baseline IL-6 at 3 months

    Time frame: at baseline and 3 months

    proinflammatory cytokines interleukin-6

  2. Change from Baseline Fatigue at 3 months

    Time frame: at baseline and 3 months

    Piper fatigue questionnaire

  3. Change from Baseline sleep quality at 3 months

    Time frame: at baseline and 3 months

    Pittsburgh sleep quality index, PSQI

  4. Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months

    Time frame: at baseline and 3 months

    Brief Pain Inventory-Short Form

  5. Change from Baseline Symptoms of climacteric syndrome at 3 months

    Time frame: at baseline and 3 months

    Kupperman Index

  6. Change from Baseline BMD at 3 months

    Time frame: at baseline and 3 months

    Bone mineral density

  7. Change from Baseline BMI at 3 months

    Time frame: at baseline and 3 months

    Body Mass Index

  8. Change from Baseline Aerobic Fitness Assessment at 3 months

    Time frame: at baseline and 3 months

    Six-min walk test (6MWT)

  9. 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)

  10. 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

  11. Change from Baseline Balance test at 3 months

    Time frame: at baseline and 3 months

    stand on one foot

  12. Change from Baseline TNF-α at 3 months

    Time frame: at baseline and 3 months

    tumor necrosis factor alpha

  13. Change from Baseline IL-1β at 3 months

    Time frame: at baseline and 3 months

    interleukin-1β

  14. Change from Baseline CRP at 3 months

    Time frame: at baseline and 3 months

    C-reactive protein

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Guangzhou Sport University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 22, 2017
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.