Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Qigong training group
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.
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.
Control group
Participants in the control group will receive no Qigong training.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
3. having completed conventional cancer treatment and medically stable
4. no known neurological deficits resulting from breast cancer treatment or other neurological disorders
5. persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
6. female aged 18 or above.
Exclusion Criteria
2. receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
3. recurrent cancer or cancer that has spread to another organ
4. participation in regular physical activity
5. prior experience of Qigong or Tai Chi
6. a smoking habit
7. pregnancy during the study period.
18 Years
FEMALE
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Shirley S.M. Fong
Assistant Professor, DRPC chairperson
Locations
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University of Hong Kong
Pokfulam, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Shirley SM Fong, PT, PhD
Role: primary
Other Identifiers
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201410159001
Identifier Type: -
Identifier Source: org_study_id