An interventional study of Qigong training in Neoplasms, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-15.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The inclusion criteria are
Exclusion Criteria:
The exclusion criteria are
Participants assigned to the Qigong group will receive Qigong training. The Qigong training programme will be run for 3 months with two supervised 1-hour sessions per week. Participants will learn the 18 Forms of Tai Chi Internal Qigong. The training sessions will be conducted by a qualified Qigong instructor from the Natural Health Qigong Association. Participants in the control group will receive no Qigong training during the study period. They will receive an 18 Forms of Tai Chi Internal Qigong training package after the study.
Behavioral: Qigong training
Participants in the control group will receive no Qigong training.
Participants will learn the 18 Forms of Tai Chi Internal Qigong. Detailed movement and breathing descriptions of the Qigong training protocol can been found in Mak YK. 18 Forms Tai Chi Qigong \[in Chinese\]. 7th ed. Hong Kong: Wan Li Book Co.; 2012.
Change in upper limb circumference
Circumference of both arms will be measured using a cloth measuring tape.
Time frame: Baseline (0 month) and post-intervention (3 months)
Change in arterial resistance and blood flow velocities
A Doppler ultrasound machine will be used to examine the arterial blood flow velocities.
Time frame: Baseline (0 month) and post-intervention (3 months)
Change in shoulder flexibility
A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction.
Time frame: Baseline (0 month) and post-intervention (3 months)
Change in shoulder muscular strength
The maximum isometric muscular strength of the shoulder flexor, abductor, internal rotator and external rotator muscles will be measured bilaterally using the Lafayette Manual Muscle Test System.
Time frame: Baseline (0 month) and post-intervention (3 months)
Change in body balance
Standing balance of the participants will be measured using timed single leg standing test.
Time frame: Baseline (0 month) and post-intervention (3 months)
Change in quality of life
Functional Assessment of Cancer Therapy - Breast scale version 4 will be used.
Time frame: Baseline (0 month) and post-intervention (3 months)
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong