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Effect of Baduanjin Exercise Intervention on Cognitive Function and Quality of Life in Women With Breast Cancer Receiving Chemotherapy: Study Protocol of A Randomized Controlled Trial
- Source :
- Trials, Vol 22, Iss 1, Pp 1-10 (2021), Trials
- Publication Year :
- 2021
- Publisher :
- Research Square Platform LLC, 2021.
-
Abstract
- Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020
- Subjects :
- Quality of life
China
Medicine (General)
medicine.medical_specialty
Medicine (miscellaneous)
Breast Neoplasms
Pilot Projects
law.invention
Study Protocol
03 medical and health sciences
Cognition
Percutaneous Coronary Intervention
Breast cancer
R5-920
0302 clinical medicine
Randomized controlled trial
law
Survivorship curve
medicine
Humans
Pharmacology (medical)
Randomized Controlled Trials as Topic
business.industry
Cancer
medicine.disease
Exercise Therapy
Clinical trial
030220 oncology & carcinogenesis
Physical therapy
Anxiety
Female
Baduanjin exercise
Cognitive function
medicine.symptom
business
030217 neurology & neurosurgery
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Trials, Vol 22, Iss 1, Pp 1-10 (2021), Trials
- Accession number :
- edsair.doi.dedup.....2f8a88a0c32228675cbec23826b27444