The Effect of Oral Contraceptives on Dynamic Balance in Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall joint stability
研究概览
简要总结
- Recording Data Sheet:
All data and information of each woman in both groups (A & B) participated in this study were recorded in a recording data sheet (Appendix II). 2. Weight-Height scale:
A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight, and 1 to 200 centimeters height was used to measure the relevant subject's data. 3. Siemens Immulite Immunoassay System:
(Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A) to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE 21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone. 4. Biodex balance system:
Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows approximately 20 degree inclination in 360 degree range and is interfaced with computer software. It measures the patient's ability to control the platform's angle of tilt, which is quantified as a variance from the center, as well as the degree of deflection over time at various stability levels as shown in (Fig. 6).
Stability levels allowed by the system ranged from one to eight. Stability level 8, allows the highest level of stability as it makes the platform to be the least tilted. On the other hand, stability level one represents the least level of stability and is more difficult for the subject to maintain stability on.
The test consists of recording the patient's ability to control the platform variance from a perfectly balanced position. A large variance is indicative of poor control and balance. Further definition is realized with the quantification of Anterior/ Posterior and Medial/Lateral responses.
详细描述
- Recording Data Sheet:
All data and information of each woman in both groups (A & B) participated in this study were recorded in a recording data sheet. 2. Weight-Height scale:
A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight, and 1 to 200 centimeters height was used to measure the relevant subject's data. 3. Siemens Immulite Immunoassay System:
(Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A) to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE 21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone. 4. Biodex balance system:
Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows approximately 20 degree inclination in 360 degree range and is interfaced with computer software. It measures the patient's ability to control the platform's angle of tilt, which is quantified as a variance from the center, as well as the degree of deflection over time at various stability levels as shown in .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women in group (A) had takenthe oral contraceptive pill have done so routinely for the past three months.
- •All women in group (B) had a normal menstrual cycle; use any other non-hormonal contraceptive method.
- •Their body mass index did not exceed 30 Kg/m
- •All women had a normal menstrual cycle of 25-32 days for the past 3 months.
- •They can stand independently.
排除标准
- •Respiratory or heart problems.
- •Skeletal deformityorusing assistive devices.
- •Visual and vestibular system affection.
- •Cognition problems.
- •Previous surgeries at their back and/or lower limbs.
- •Genital and breast cancer and active liver disease.
研究组 & 干预措施
Oral contraceptive pills users
The participants received treatment for 6 consecutive cycles. Each treatment cycle consisted of 3 weeks of ring/pill treatment followed by a 1-week pill-free period. The women were randomized in a 1:1 ratio to receive the COC containing 30 μg of EE and 3mg of drospirenone (Yasmin; Schering AG, Berlin, Germany)
干预措施: COC containing 30 μg of EE and 3mg of drospirenone (Drug)
结局指标
主要结局
overall joint stability
时间窗: 6 months after pill use
A) Biodex balance system: Testing procedures was done at mid-luteal phase (20th to 23th days of the cycle). Each woman was received verbal explanation about the test steps. The woman was tested without footwear and with eyes opened. Two test trials was done before specific test condition for the purpose of instrument familiarity prior to data collection. A high stability level (stability level 8) and reduced test time (20 sec) was chosen to avoid falling. Each woman was asked to perform two trial tests and their mean was calculated. Each test started with the balance platform in the locked position and standing on its center.
次要结局
- side effects(6 months after pill use)
研究者
Ahmed Maged
Assistant professor
Cairo University