Neoplasms
Conditions
Brief summary
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.
Interventions
BEHAVIORALQigong 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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial resistance and blood flow velocities | Baseline (0 month) and post-intervention (3 months) | A Doppler ultrasound machine will be used to examine the arterial blood flow velocities. |
| Change in upper limb circumference | Baseline (0 month) and post-intervention (3 months) | Circumference of both arms will be measured using a cloth measuring tape. |
| Change in shoulder flexibility | Baseline (0 month) and post-intervention (3 months) | A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction. |
| Change in shoulder muscular strength | Baseline (0 month) and post-intervention (3 months) | 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. |
| Change in body balance | Baseline (0 month) and post-intervention (3 months) | Standing balance of the participants will be measured using timed single leg standing test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Baseline (0 month) and post-intervention (3 months) | Functional Assessment of Cancer Therapy - Breast scale version 4 will be used. |
Countries
Hong Kong
Contacts
Primary ContactShirley SM Fong, PhD
Outcome results
None listed