- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02420249
Qigong for Breast Cancer Survivors
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
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pokfulam, 홍콩
- 모병
- University of Hong Kong
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The inclusion criteria are
- history of a breast malignancy of any stage
- history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
- having completed conventional cancer treatment and medically stable
- no known neurological deficits resulting from breast cancer treatment or other neurological disorders
- persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
- female aged 18 or above.
Exclusion Criteria:
The exclusion criteria are
- presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder
- receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
- recurrent cancer or cancer that has spread to another organ
- participation in regular physical activity
- prior experience of Qigong or Tai Chi
- a smoking habit
- pregnancy during the study period.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
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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.
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간섭 없음: Control group
Participants in the control group will receive no Qigong training.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in upper limb circumference
기간: Baseline (0 month) and post-intervention (3 months)
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Circumference of both arms will be measured using a cloth measuring tape.
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Baseline (0 month) and post-intervention (3 months)
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Change in arterial resistance and blood flow velocities
기간: Baseline (0 month) and post-intervention (3 months)
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A Doppler ultrasound machine will be used to examine the arterial blood flow velocities.
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Baseline (0 month) and post-intervention (3 months)
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Change in shoulder flexibility
기간: Baseline (0 month) and post-intervention (3 months)
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A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction.
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Baseline (0 month) and post-intervention (3 months)
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Change in shoulder muscular strength
기간: Baseline (0 month) and post-intervention (3 months)
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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.
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Baseline (0 month) and post-intervention (3 months)
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Change in body balance
기간: Baseline (0 month) and post-intervention (3 months)
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Standing balance of the participants will be measured using timed single leg standing test.
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Baseline (0 month) and post-intervention (3 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in quality of life
기간: Baseline (0 month) and post-intervention (3 months)
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Functional Assessment of Cancer Therapy - Breast scale version 4 will be used.
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Baseline (0 month) and post-intervention (3 months)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 201410159001
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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