Effects of Supervised Structured Aerobic Exercise Training Program on Serum BDNF, Androgens Level, Menstrual Irregularity and Quality of Life in Females With Insulin Resistant Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depression Anxiety Stress Scale (DASS)
研究概览
简要总结
Design: RCT Randomized Clinical Trial Non Probability Convenient Sampling Technique Duration of treatment: 25 weeks 2 groups; (group A=30) SSAET +Normal routine medication+ Normal Dietary Plan , Other group (Group B=30) with normal routine medication + Normal Dietary Plan.
Patients will be enrolled in experimental group according to speeds test.
HYPOTHESIS:
Alternate hypothesis:
There is difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome.
Null Hypothesis:
There is no difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome.
OBJECTIVES:
To determine the effects of Supervised Structured Aerobic Exercise Training Program on quality of life in women with PCOS.
2. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BDNF levels in women with PCOS.
3. To determine the effect of Supervised Structured Aerobic Exercise Training Program on mental health (stress, depression, anxiety) in women with PCOS.
4. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BMI in women with PCOS.
5. To determine the effect of Supervised Structured Aerobic Exercise Training Program on menstrual irregularity in women with PCOS.
6. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Aerobic fitness in women with PCOS.
7. To determine the effect of Supervised Structured Aerobic Exercise Training Program on androgens level in PCOS.
8. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Lipid accumulation product in PCOS.
9. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Glycemic control in PCOS.
详细描述
Polycystic ovarian syndrome is a very common systemic disease consisting of hormone problem for women of childbearing age. Women with PCOS may not ovulate, have high levels of androgens, and have many small cysts on the ovaries. PCOS can cause missed or irregular menstrual periods, excess hair growth, acne, infertility, and weight gain. BDNF is linked with exercise and its receptors are also in ovaries. Hence, if the levels of BDNF falls below average then it plays an important role in hyperandrogenism and this often accompanied with lack of physical activity. Another factor, lipid accumulation product is closely related to glucose intolerance and wight gain which eventually gives rise to hyperandrogenism and it eventually affects the quality of life of females with polycystic ovarian syndrome.
It will be a randomized controlled trial. Convenient sampling technique would be used.
Inclusion criteria would be females of age 18-35 years, insulin resistant polycystic ovarian syndrome, pre-diagnosed, married and un married both, diabetic & nulliparous females.
Exclusion criteria would be post pill, Inflammatory & Adrenal PCOS, any psychological disease or disorder, any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, renal tumor, etc), Orthopedic conditions (including fracture, dislocation, etc), any surgery in past 6 months, involved in any other exercise regimen at the same time, having any specialized diet plan & Pregnant females.
Patients enrolled in the study will be divided randomly by even odd method. (Group A=30) will be given the Supervised Structured Aerobic Exercise Treatment Program for 12 weeks along with their normal routine medications given to them by their gynecologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 To 35 years Females.
- •Insulin resistant PCOS type.
- •Already Diagnosed patients form gynecological department according to the Rotterdam criteria.
- •Both Married and unmarried females.
- •Nulliparous females.
排除标准
- •Post pill PCOS, Inflammatory PCOS & Adrenal PCOS
- •Any psychological disease or disorder
- •Any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, etc)
- •Orthopedic conditions (including fracture, dislocation, etc)
- •Any surgery in past 6 months.
- •Involved in any other exercise regimen at the same time.
- •Having any specialized diet plan.
研究组 & 干预措施
Interventional group- PCOS
25 weeks of supervised structured aerobic exercise treatment program will be applied on the females with PCOS in the gym setting.
干预措施: Supervised structured aerobic exercise training (Other)
Second group- PCOS
walk will be asked for these patients and their feedback will be taken through cell phone
干预措施: Walk (Other)
结局指标
主要结局
Depression Anxiety Stress Scale (DASS)
时间窗: 12 weeks and 25 weeks
Mental Health (Stress, depression \& Anxiety) by DASS 21 Scoring Process: 1. Sum the scores for each subscale: Add the scores for the 7 items within each subscale (Depression, Anxiety, and Stress). 2. Multiply by 2: Multiply the sum of each subscale by 2 to get the final score for each area (Depression, Anxiety, and Stress). 3. Interpret the scores: The resulting scores are then interpreted using the provided severity levels for each subscale. Severity Levels: The DASS-21 provides severity levels for each subscale: Depression: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+). Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+). Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+). \> Higher the scores means more severity and less healthy.
Polycystic ovarian syndrome Quality of Life Questionnaire (PCOSQOL)
时间窗: 12 weeks and 25 weeks
This is a tool to measure quality of life in females with Polycystic Ovarian syndrome. There are total 35 Questions in it. Scoring: Summate each item to give a total score. A low score represents that a lower quality of life, a higher score represents a lesser to no impact on quality of life.
MIQ (Menstrual Irregularity Questionnaire)
时间窗: 12 weeks and 25 weeks
Measures menstrual irregularity The MIQ is a 6-point questionnaire, and the total score reflects the overall impact of heavy menstrual bleeding on the woman's life. Higher scores indicate a greater negative impact of heavy menstrual bleeding on the woman's quality of life. The MIQ helps healthcare professionals understand the severity of the problem and tailor treatment accordingly.
3 min bench step test II. Indirect estimation of VO2 max by formula VO2 max (walking) = (0.2 x speed of treadmill) + (0.9 x speed x treadmill grade) + 3.5
时间窗: 12 weeks and 25 weeks
To measure Aerobic fitness. YMCA 3-minute Bench Step Test: You step up and down on a 30 cm (12-inch) step for three minutes at a consistent pace, and your heart rate is measured afterward to estimate fitness for 1 minute through carotid artery. The more fit you are, the lower your recovery heart rate will be, meaning a lower number is a better score. Compare to Charts: Use your age and gender to find the appropriate fitness rating chart, such as the YMCA charts. Determine Your Level: The chart will show whether your 1-minute heart rate falls into categories like excellent, good, above average, average, or below average fitness. YMCA FEMALES Scoring: Excellent \<109 Above Average 110 - 117 Average 118 - 134 Below Average 135-137 Poor \>137
ELISA
时间窗: 12 and 25 weeks
BDNF levels
Androgens level
时间窗: 12 weeks and 25 weeks
Serum SHBG will be measured by coated-tube immunoradiometric assay using commercial kits. Testosterone will be measured by RIA using commercial enzymatic kits. Free androgen index (FAI) will be calculated as testosterone/SHBG × 100. Clinical hyperandrogenism (a score of 6 or higher on the modified Ferriman-Gallwey scale)
次要结局
- HOMA-IR for Glycemic control(12 weeks and 25 weeks)
- Lipid Accumulation Product(12 weeks and 25 weeks)
- BMI(12 weeks and 25 weeks)
研究者
Muzna Munir
Assistant Professor
Riphah International University