Effects of Selected Exercise Program on Microcirculation and Lymphedema in Postmastectomy Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- microcirculation of blood cells
研究概览
简要总结
PURPOSE: to assess the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.
BACKGROUND: Qigong is a mind-body integrative exercise originating from traditional Chinese medicine and is used to improve health and energy levels through regular training, yet its effects are not empirically assessed.
Qigong may be a potentially beneficial exercise for survivors of breast cancer and could be used to regulate upper limb blood flow and decrease lymphedema. There is lack in knowledge and information in published studies about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.
So, this study will be designed to provide a guideline about the efficacy of Qigong exercise on microcirculation in postmastectomy lymphedema patient.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Qigong exercise has no or limited effect in microcirculation in postmastectomy lymphedema patient.
RESEARCH QUESTION: Does Qigong exercise an effect on microcirculation in postmastectomy lymphedema patient?
详细描述
- Measurement procedure:
Both methods of measurements will be done before the beginning of the treatment (pre-treatment) then at the end of the study after 2 months of treatment (post treatment) for both groups of the study.
A-Upper Limb Circumference by manual goniometer
B- LASER Doppler Imaging: 2. Treatment procedures:
In this study the treatment protocol was presented in the form of an exercise program lasted for 60 minutes, twice weekly for 8 weeks postmastectomy and achieved under the following phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age from 25-40 years
- •with or without adjuvant chemotherapy/ radiotherapy
- •had completed conventional treatments of breast cancer
- •medically stable
- •had lymphedema, defined as a circumference difference greater than 2 cm at any point between the surgical-side upper limb and the contralateral upper limb
- •had no known neurological deficit resulting from breast cancer treatment.
- •Participants were also able to perform 18 Forms Tai Chi Internal Qigong independently.
排除标准
- •Participants were excluded if they:
- •had significant neurological, musculoskeletal, cardiovascular, peripheral vascular, or kidney disorders.
- •had recurrent breast cancer or cancer in another organ during the study period.
- •did regular exercises other than qigong
- •received lumpectomy but not mastectomy
- •pregnant during the study period.
研究组 & 干预措施
group A
Qigong exercise program twice weekly for 8 weeks postmastectomy in addition to traditional medical and physical therapy treatment.
干预措施: Qigong exercise (Combination Product)
group B
traditional medical and physical therapy treatment only .
干预措施: Qigong exercise (Combination Product)
结局指标
主要结局
microcirculation of blood cells
时间窗: changes from the baseline at 2 months after treatment
* As these blood cells are moving, the reflected light is subject to the Doppler shift, which is a small change in frequency. * When laser light penetrates the tissue under study it is scattered and partly absorbed. Some of the scattered light returns to the tissue surface, where it is registered by a photo detector inside the instrument. This signal is then processed to extract information about the microcirculatory blood flow. According to the Doppler principle, light particles which hit moving blood cells undergo a change in wavelength/frequency (a Doppler shift), while light particles which encounter static structures return unchanged. The perfusion can be calculated since the magnitude and frequency distribution of the doppler shifted light are directly related to the number and velocity of blood cells but unrelated to their direction of movement.
Upper Limb Circumference
时间窗: changes from the baseline at 2 months after treatment
The circumferences of both arms that represented the participants' lymphedema status were taken at the level of (a) 10 cm proximal to the lateral epicondyle; (b) the elbow joint, right at the lateral epicondyle; (c) 10 cm distal to the lateral epicondyle; and (d) the wrist joint, just distal to the ulnar styloid process. The upper limb circumferences were measured with a cloth measuring tape. The difference in each circumference measurement between the ipsilateral and contralateral arms was calculated to detect a 2 cm between-side difference.
次要结局
未报告次要终点
研究者
Eman Mohamed othman
professor
Cairo University