NCT07522593

Brief 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 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

March 30, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

breast cancer survivorsBaduanjin exercisepilot studyrandomised control trail

Outcome Measures

Primary Outcomes (1)

  • 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.

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

Secondary Outcomes (5)

  • Shoulder Range of Motion (ROM)

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

  • Pain

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

  • Sleep Quality

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

  • Depression and Anxiety

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

  • Quality of Life(QoL)

    At enrollment, at the end of the intervention, and eight weeks after the intervention completion

Study Arms (2)

Baduanjin arm

EXPERIMENTAL

Participants in this arm will adopte Baduanjin exercise following the intervention protocol

Behavioral: Baduanjin exercise

Control arm

NO INTERVENTION

Participants in this arm will take their routine activity.

Interventions

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.

Baduanjin arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-01

Locations