Neoplasms Clinical Trial
Official title:
Randomised Controlled Trial of Qigong Training Programme to Alleviate Arm Oedema, ¬Reduce Shoulder Impairment, Improve Body Balance and Quality of Life in Community-dwelling Breast Cancer Survivors
Objectives: (1) To investigate the effects of Qigong training on upper limb oedema,
circulatory status, shoulder flexibility and muscular strength, body balance, and quality of
life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the
relationship between the impairment outcomes and QOL outcomes.
Hypothesis: (1) The experimental participants will have less impairment and a better QOL
after Qigong training compared with the no-training control group; and (2) the impairment
parameters will be related to the QOL indexes in the Qigong participants.
Design and subjects: This will be a prospective, randomised, single-blinded controlled
trial. Approximately 60 breast cancer survivors will be randomly assigned to either the
Qigong training group (n~30) or control group (n~30).
Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal
Qigong training for 3 months with two supervised 1-hour sessions per week.
Main outcome measures: The primary outcome measures are upper limb circumference, arterial
blood flow velocities and resistance index, shoulder joint passive range of motion, muscular
strength (peak force) and body balance. The secondary outcome measure is quality of life as
measured by the Functional Assessment of Cancer Therapy - Breast scale.
Data analysis: Data will be analysed via repeated-measures analysis of variance followed by
post-hoc tests (α = 0.05).
Expected results: The investigators pilot studies produced encouraging results on the
efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors.
Therefore, the investigators expect that participants in the Qigong group will have fewer
upper limb impairments and a better quality of life after Qigong training. If the results
are positive, this Qigong training regime is readily transferrable to clinical practice, and
could have positive socioeconomic effects such as reduced healthcare costs.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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