Qigong for Breast Cancer Survivors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02420249
• Other study ID #: 201410159001
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2015
• Last updated: December 13, 2015
• Start date: March 2015

Study information

• Verified date: December 2015
• Source: The University of Hong Kong
• Contact: Shirley SM Fong, PhD
• Phone: 85297090337
• Email: smfong[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: University of Hong Kong
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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