A Randomized, Open, Single Center Clinical Study of Dragon Boat Race Versus Family Unsupervised Training to Improve the Physical Function and Quality of Life in Breast Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Investigators plans to conduct a randomized, open, single center clinical study of Dragon Boat Race versus family unsupervised training to improve the physical function and quality of life in breast cancer patients to compare the effects of organized and supervised short-term dragon boat training versus unsupervised home training on body composition, physical function, and quality of life in women after breast cancer surgery. Participants will be assigned to the following intervention protocols at a 1:1 ratio:Dragon Boat Training Group (DB): Conduct 12-week dragon boat training under the guidance of professional coaches.Home-based Unsupervised Training Group (HG): Perform exercises at home independently according to instructional videos for 12 weeks.The primary outcomes are to analyze differences in body composition, physical function, and quality of life.The secondary exploratory outcomes include stratified factors such as menopausal status and surgical methods

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Female patients aged 18-75 years;

• ECOG performance status of 0-1;

• BMI between 18.0 and 30.0;

• No prior experience with dragon boat or kayaking;

• Histologically or pathologically confirmed invasive breast cancer;

• Function levels of major organs must meet the following requirements (no blood transfusion, no use of leukocyte-elevating or platelet-elevating drugs within 2 weeks before screening):

‣ Routine blood test: absolute neutrophil count (ANC) \> 1.5×10⁹/L; platelet count (PLT) \> 75×10⁹/L; hemoglobin (Hb) \> 90g/L; lymphocyte count ≥ 1.5×10⁹/L.

⁃ Blood biochemistry: total bilirubin (TBIL) \< 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.5×ULN; alkaline phosphatase \< 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) \< 1.5×ULN.

⁃ Echocardiography: left ventricular ejection fraction (LVEF) \> 55%.

⁃ 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec. For premenopausal female patients or those not surgically sterilized: effective contraceptive methods must be used during treatment and for at least 6 months after the last dose in the study treatment.

• Voluntary participation in the study, signing of informed consent, good compliance, and willingness to cooperate with follow-up.

Locations
Other Locations
China
The First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Zhijun Dai Professor
dzj0911@126.com
+86 157 0581 9132
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-04-07
Participants
Target number of participants: 72
Treatments
Experimental: Dragon Boat Training Group (DB)
The total training duration is 12 weeks, divided into cycles of 4 weeks each, with distinct training contents and goals for every cycle. Training sessions are held 3 times a week, and all participants train together on the same day. Each training session lasts approximately 60 minutes.~In the first 4 weeks, participants spend half an hour training on land and the subsequent half an hour training on dragon boats.~Then, from week 4 to week 8, they train for 20 minutes on land and 40 minutes on dragon boats.~Finally, from week 8 to week 12, they only conduct 10-15 minutes of land training (as warm-up) followed by nearly an hour of on-boat training.~This progressive training plan is designed to ensure that each participant can tolerate the training intensity as much as possible, preventing injuries caused by training.
Active_comparator: Home-based Unsupervised Training Group (HG)
The total training duration is 12 weeks. After a 15-minute warm-up (including walking, exercises, etc.), participants will perform the following 10 movements in sequence: squats, rowing simulation with rubber bands, lateral raises, sit-ups, shoulder presses, alternating bilateral lunges, dumbbell curls (for biceps), sit-ups, and planks.~Each movement lasts 60 seconds, with a 10-second rest allowed midway through the same movement (i.e., 15 seconds of exercise followed by a 10-second rest, then another 15 seconds to complete the movement). A 20-second rest is permitted before moving on to the next movement.~Once participants can complete 30 seconds of the same movement without needing rest or adjustment, the training intensity will be increased-progressing from one round of training (10 minutes) to two rounds (20 minutes) or even three rounds (30 minutes).
Related Therapeutic Areas
Breast Cancer
Sponsors
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov

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