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
NCT number | NCT02420249 |
Other study ID # | 201410159001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | April 9, 2015 |
Last updated | December 13, 2015 |
Start date | March 2015 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: The inclusion criteria are 1. history of a breast malignancy of any stage 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: The exclusion criteria are 1. presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | University of Hong Kong | Pokfulam |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in upper limb circumference | Circumference of both arms will be measured using a cloth measuring tape. | Baseline (0 month) and post-intervention (3 months) | No |
Primary | Change in arterial resistance and blood flow velocities | A Doppler ultrasound machine will be used to examine the arterial blood flow velocities. | Baseline (0 month) and post-intervention (3 months) | No |
Primary | 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. | Baseline (0 month) and post-intervention (3 months) | No |
Primary | 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. | Baseline (0 month) and post-intervention (3 months) | No |
Primary | Change in body balance | Standing balance of the participants will be measured using timed single leg standing test. | Baseline (0 month) and post-intervention (3 months) | No |
Secondary | Change in quality of life | Functional Assessment of Cancer Therapy - Breast scale version 4 will be used. | Baseline (0 month) and post-intervention (3 months) | No |
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