Breast Cancer SurvivorNCT07522593
Baduanjin Exercise on Upper Limb Dysfunction Among Breast Cancer Survivors
A study testing Baduanjin exercise in people with Breast Cancer Survivor, run by University of Southern Queensland at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Baduanjin exercise could be adopted by breast cancer survivors and improve their upper limb dysfunction. The main questions it aims to answer are: Does Baduanjin exercise improve upper limb dysfunction among breast cancer survivors? What problems or adverse events do… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor
- What is being tested?
- Baduanjin exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged ≥ 18 years, diagnosed with non-metastatic unilateral Stage I-IIIa non-metastatic breast cancer, regardless of cancer type;
- Surgeries completed at least two months before enrolment, and completion of radiotherapy and/or chemotherapy, with or without aromatase inhibitor therapy, upon enrolment;
- Experiencing breast cancer treatment-related ULD, which is measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) scale with a score of 20 or above;
- Karnofsky Performance Status Scale (KPS), used to measure a patient's ability to perform daily activities and self-care independently, with a score of 90 or above;
- Ability to read, write, and communicate in Chinese;
- Have a personal cellphone;
- Agree to participate in this study and provide written informed consent.
Who cannot join
- Any patient with a history of upper limb surgery, injury (fracture or shoulder dislocation), or other conditions not related to breast cancer treatments;
- With other complications or adverse medical conditions that cannot perform BdjE, such as severe lymphedema, axillary web syndrome, or adhesive capsulitis;
- Undergoing any physiotherapy for ULD or leading regular physical exercises in the previous three months;
- Had skin grafting and autologous myocutaneous flap breast reconstruction;
- Current clinical diagnosis of depression or anxiety, or receipt of active psychological treatment for significant mood or anxiety disorders;
- Currently involved in other clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
LI Yang, 86-15185210524, 583726149@qq.com
About this study
Official title: Feasibility and Preliminary Evaluation of an Evidence-based Baduanjin Exercise Program for Upper Limb Dysfunction in Breast Cancer Survivors: A Pilot Randomised Controlled Trial
The goal of this clinical trial is to learn if Baduanjin exercise could be adopted by breast cancer survivors and improve their upper limb dysfunction. The main questions it aims to answer are:
- Does Baduanjin exercise improve upper limb dysfunction among breast cancer survivors?
- What problems or adverse events do participants have if they adopt Baduanjin exercise to improve upper limb dysfunction?
Participants will:
- Adopt Baduanjin exercise following an evidence-based intervention protocol
- Report their exercise frequency, length, and unexpected symptoms
- Receive three times assessment and follow-up every week
Read the detailed description
To evaluate the feasibility, acceptability, and preliminary effects of Baduanjin exercise on upper limb dysfunction (ULD), shoulder range of motion (ROM), pain, sleep quality, depression and anxiety, and quality of life (QoL) in breast cancer survivors. The objectives of this study are to:
- Develop an evidence-based Badunajin exercise intervention protocol for managing ULD among breast cancer survivors ;
- Design and conduct a pilot Randomised Controlled Trial (RCT) using the Buduanjin exercise intervention protocol to manage the ULD;
- Test the feasibility and acceptability of the Baduanjin exercise intervention and RCT procedures by the recruitment rate, retention rate, and attrition rate during the pilot RCT;
- Evaluate the safety, efficacy, and acceptability of the Baduanjin exercise intervention by identifying potential adverse effects associated with the Baduanjin exercise intervention;
- Examine the potential effects of Baduanjin exercise intervention on ULD, shoulder ROM, pain, sleep quality, depression and anxiety, as well as QoL among breast cancer survivors;
- Explore the participants' experience and suggestions for the Baduanjin exercise intervention and study procedures; and
- Provide evidence for refinement of the Baduanjin exercise intervention for a multi-center, full-scale RCT among breast cancer survivors.
- Conditions
- Breast Cancer Survivor
- Being tested
- Baduanjin exercise
- Keywords
- breast cancer survivors, Baduanjin exercise, pilot study, randomised control trail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseBehavioural
Baduanjin exercise is a low-to-moderate-intensity aerobic mind-body exercise that integrates movement (physical postures), meditation (focused attention), and controlled breathing. When practicing it, people stand in a position and perform eight movements, including 1) Two Hands Hold up the Heavens; 2) drawing the bow to shoot the eagle; 3)separate heaven and earth, 4)wise owl gazes backward or looking back, 5)sway the head and shake the tail, 6)two hands hold the keen to strengthen the kidneys and waist, 7) clench the fists and glare fiercely; 8) bouncing on the toes seven times.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin arm | Experimental | Participants in this arm will adopte Baduanjin exercise following the intervention protocol Receives: Behavioral: Baduanjin exercise |
| Control arm | No intervention | Participants in this arm will take their routine activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Dysfunction
The Disability of Arm, Shoulder, and Hand (DASH) (Chinese version) will assess upper limb dysfunction. The DASH has 30 items, and 5-Likert scale was used to demonstrate the disability of the upper limb (1=not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely), and DASH symptom score = [(sum of n response)/n-1] *25 (n is the number of completed responses)(Hudak et al., 1996). A higher score indicates a greater disability. At least 27 items must be completed for each questionnaire, or it will not be able to calculate a score.
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Secondary outcomes (5)
Shoulder Range of Motion (ROM)
The shoulder ROM includes flexion, extension, abduction, adduction, and internal and external rotation. A digital goniometer is a precision instrument commonly used to measure shoulder ROM in clinical settings. each movement will be measured and recorded once per assessment to minimize fatigue and prevent artificially increased ROM due to repeated measurements
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Pain
The brief pain inventory (BPI) will be employed to measure pain among BCSs, which is a self-administered measure that can rapidly assess the intensity of pain and the impact of pain on daily function.
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) (Chinese version) was adopted to evaluate sleep quality in the project. It was developed in 1989, with 19 items in seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction (Buysse et al., 1989). Each component score ranges from 0 (no difficulty) to 3 (severe difficulty), and the global score ranges from 0 to 21 points; a higher score indicates a worse sleep quality (Buysse et al., 1989).
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Depression and Anxiety
The Hospital Anxiety and Depression Scale (HADS) was selected to assess the participants' depression and anxiety. HADS was developed in 1983 with 14 items, 7 items measuring cognitive and emotional aspects of depression, intermingled with 7 items that focus on cognitive and emotional aspects of anxiety(Zigmond \& Snaith, 1983). Each item is scored from 0 to 3, resulting in a total subscale score ranging from 0 to 21. Higher scores indicate greater levels of depression or anxiety(Zigmond \& Snaith, 1983)
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Quality of Life(QoL)
FACT-B+4 will be used to assess the QoL among breast cancer survivors with upper limb dysfunction. FACT-B has 37 items, including 7 items for physical well-being, 7 items for social/family well-being, 6 items for emotional well-being, 7 items for functional well-being, and 10 additional items specific to breast cancer concerns(Brady et al., 1997). The FACT-B+4 is an extended version of the original one, and the "+4" refers to four additional items specifically designed to assess arm morbidity in BCSs(Coster et al., 2001). Each item of the FACT-B+4 is rated on a 5-point Likert scale from 0 (not at all) to 4 (very much), and the total score range is 0-168 (Some items are reverse scored). A higher score indicates a better QoL.
Measured: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinqiu Li, University of Southern Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522593
- Sponsor's protocol ID
- ETH2025-0586
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Evaluation of an Evidence-based Baduanjin Exercise Program for Upper Limb Dysfunction in Breast Cancer Survivors: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07522593
- Acronym / sponsor ID
- ETH2025-0586
- Conditions
- Breast Cancer Survivor
- Keywords
- breast cancer survivors, Baduanjin exercise, pilot study, randomised control trail
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Southern QueenslandUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Baduanjin exercise could be adopted by breast cancer survivors and improve their upper limb dysfunction. The main questions it aims to answer are:
- Does Baduanjin exercise improve upper limb dysfunction among breast cancer survivors?
- What problems or adverse events do participants have if they adopt Baduanjin exercise to improve upper limb dysfunction?
Participants will:
- Adopt Baduanjin exercise following an evidence-based intervention protocol
- Report their exercise frequency, length, and unexpected symptoms
- Receive three times assessment and follow-up every week
Detailed description
To evaluate the feasibility, acceptability, and preliminary effects of Baduanjin exercise on upper limb dysfunction (ULD), shoulder range of motion (ROM), pain, sleep quality, depression and anxiety, and quality of life (QoL) in breast cancer survivors. The objectives of this study are to:
- Develop an evidence-based Badunajin exercise intervention protocol for managing ULD among breast cancer survivors ;
- Design and conduct a pilot Randomised Controlled Trial (RCT) using the Buduanjin exercise intervention protocol to manage the ULD;
- Test the feasibility and acceptability of the Baduanjin exercise intervention and RCT procedures by the recruitment rate, retention rate, and attrition rate during the pilot RCT;
- Evaluate the safety, efficacy, and acceptability of the Baduanjin exercise intervention by identifying potential adverse effects associated with the Baduanjin exercise intervention;
- Examine the potential effects of Baduanjin exercise intervention on ULD, shoulder ROM, pain, sleep quality, depression and anxiety, as well as QoL among breast cancer survivors;
- Explore the participants' experience and suggestions for the Baduanjin exercise intervention and study procedures; and
- Provide evidence for refinement of the Baduanjin exercise intervention for a multi-center, full-scale RCT among breast cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin arm | Experimental | Behavioral: Baduanjin exerciseParticipants in this arm will adopte Baduanjin exercise following the intervention protocol |
| Control arm | No intervention | –Participants in this arm will take their routine activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, aged ≥ 18 years, diagnosed with non-metastatic unilateral Stage I-IIIa non-metastatic breast cancer, regardless of cancer type;
- Surgeries completed at least two months before enrolment, and completion of radiotherapy and/or chemotherapy, with or without aromatase inhibitor therapy, upon enrolment;
- Experiencing breast cancer treatment-related ULD, which is measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) scale with a score of 20 or above;
- Karnofsky Performance Status Scale (KPS), used to measure a patient's ability to perform daily activities and self-care independently, with a score of 90 or above;
- Ability to read, write, and communicate in Chinese;
Key exclusion criteria (6 listed)
- Any patient with a history of upper limb surgery, injury (fracture or shoulder dislocation), or other conditions not related to breast cancer treatments;
- With other complications or adverse medical conditions that cannot perform BdjE, such as severe lymphedema, axillary web syndrome, or adhesive capsulitis;
- Undergoing any physiotherapy for ULD or leading regular physical exercises in the previous three months;
- Had skin grafting and autologous myocutaneous flap breast reconstruction;
- Current clinical diagnosis of depression or anxiety, or receipt of active psychological treatment for significant mood or anxiety disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exerciseBaduanjin exercise is a low-to-moderate-intensity aerobic mind-body exercise that integrates movement (physical postures), meditation (focused attention), and controlled breathing. When practicing it, people stand in a position and perform eight movements, including 1) Two Hands Hold up the Heavens; 2) drawing the bow to shoot the eagle; 3)separate heaven and earth, 4)wise owl gazes backward or looking back, 5)sway the head and shake the tail, 6)two hands hold the keen to strengthen the kidneys and waist, 7) clench the fists and glare fiercely; 8) bouncing on the toes seven times. | Behavioural | Baduanjin arm |
Primary outcome
Upper Limb Dysfunction
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
The Disability of Arm, Shoulder, and Hand (DASH) (Chinese version) will assess upper limb dysfunction. The DASH has 30 items, and 5-Likert scale was used to demonstrate the disability of the upper limb (1=not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely), and DASH symptom score = [(sum of n response)/n-1] *25 (n is the number of completed responses)(Hudak et al., 1996). A higher score indicates a greater disability. At least 27 items must be completed for each questionnaire, or it will not be able to calculate a score.
5 secondary outcomes
Shoulder Range of Motion (ROM)
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Pain
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Sleep Quality
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Depression and Anxiety
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Quality of Life(QoL)
Time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise in people with Breast Cancer Survivor, run by University of Southern Queensland at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinqiu LI (610430499054, jinqiu.li@unisq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Dysfunction (time frame: At enrollment, at the end of the intervention, and eight weeks after the intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.