Clinical trial NCT02420249: Qigong for Breast Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in upper limb circumference
timeFrame: Baseline (0 month) and post-intervention (3 months)
measure: Change in arterial resistance and blood flow velocities
timeFrame: Baseline (0 month) and post-intervention (3 months)
measure: Change in shoulder flexibility
timeFrame: Baseline (0 month) and post-intervention (3 months)
measure: Change in shoulder muscular strength
timeFrame: Baseline (0 month) and post-intervention (3 months)
measure: Change in body balance
timeFrame: Baseline (0 month) and post-intervention (3 months)
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline (0 month) and post-intervention (3 months)
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: University of Hong Kong
Study officials:
References: