الفهرس 
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Abstract
For many years the most conventional treatment for menopausal symptoms
worldwide has been the use of HRT. However, because of its significant associative risks,
more women are turning to the use of complementary & alternative therapies that would
not only be risk-free, but would also compensate for the estrogen deficiency. Soy food is
believed “natural estrogen” that would provide all of the benefits but none of the risks of
prescribed hormones. Also, Pilates exercise has been widely used in fields which include
many exercises that induce palliative care and obstetric & gynecologic nursing for
menopausal women.
The present study is a quasi-experimental research design. The study aimed to
determine the effect of soy isoflavones consumption versus modified Pilates exercise program
on menopausal symptoms. The study was conducted at the health clinics of eight none-medical
colleges affiliated to the University of Alexandria namely: Faculty of Commerce, Engineering,
Education of early childhood, Fine Arts, Agriculture, Science, Specific Education and
Economics studies & Political Science. A purposively selected 80 females aged from 50 years
and more, comprised the study subjects, were having menopausal symptoms. The study
subjects were divided equally into Soya and Pilates groups.
Tools:
Two tools were used for data collection, tool one: Basic data structured interview
schedule, used for assessment of basic data such as: age, education, marital status &
duration of marriage, residence, family income and crowding index as well as, clinical data
such as: weight, height, body mass index, medical condition. Reproductive history
comprised: number of gravity, parity and number of abortions. It also included menstrual
& menopausal history as: age of menopausal onset, duration since last menstruation and
personal habits as: nature of physical activity, daily dietary and knowledge about soybean
and Pilates exercise.
Tool II: Menopausal Symptoms Rating Scale: this scale was adopted and used to assess
the severity of menopausal symptoms before and after intervention. It composed of eleven
symptoms that grouped into 3 categories: Somatic (4) symptoms, Psychological (4) symptoms
and urogenital (3) symptoms.
Total symptoms score ranged from 11 to 44 where, each menopausal woman‟s total
score was categorized as follow:
Mild menopausal symptoms if her total score 11≤ 18.
Moderate menopausal symptoms if her total score 19-26.
Severe menopausal symptoms if her total score 27-34.
Very sever menopausal symptoms if her total score ≥35.
Methods of the study
A certificate about the safety & benefits of soybean isoflavones for menopausal
symptoms was issued by Prof. Dr. Salama El-Dareer - Professor Emeritus of the
Botany and Microbiology department Faculty of Science - Alexandria University and
prof. Dr. Mohamed Hussein Khalil - prof. of Obstetric and Gynecological Medicine,
Faculty of Medicine Alexandria University (Appendix III).
Official letters from the Faculty of Nursing Alex University were submitted to the
chosen study settings for obtaining their permission to carry out the study and collect
the necessary data after explaining the aim of the study.
Preparation of soy isoflavones and capsules:
The soy isoflavones was prepared for oral administration in a hard gelatin capsules
as followed;
3 kg soybeans was purchased from the local stores, washed under distilled water,
dried and crushed. (This quantity was sufficient to prepare 11205 capsules).
Each capsule equivalent to 35 mg powdered soybean isoflavones totaling of 105 mg
per day for 12 weeks (90 days). This is to say: 3 capsules x 90 days x 40 cases.
The capsules were prepared under supervision of prof. Dr. Salama El-Darier, at the
Botany and Microbiology department, Science Faculty, University of Alexandria.
Finally each 136 capsules were placed in one package for individual 6-weeks use. A
total of 80 packages were prepared.
Tool I was developed by the researcher after reviewing related literature
Tool II was adopted and translated into Arabic.
Tools content validity was tested by a jury of five experts in the related field. The
required corrections and modifications were carried out accordingly. Then the
reliability of the tools was done.
A pilot study was carried out on 8 women and following this pilot study, the
necessary modifications for the tools were done and a plan to resolve the
implementation obstacles was put and considered during the actual study process
and data collection.
Soya group consumed soybean isoflavones therapy for twelve weeks (90 days)
three times per day & Pilates group performed Pilates exercise program, two
session per weekly, each session lasted nearly 40 minutes (outside working hours
and agreement was obtained from the subjects) 10 min. for warming phase, 20 for
the main exercise program phase and the last phase for cooling exercises.
Data collection:
After securing the administrative approval, the data were collected over a period of
5 months from 8th November 2019 to 28th march 2020. The data was conducted
through three phases:
I. The assessment phase:
The researcher screened for all menopausal women using tool II. The 80 eligible
subjects who had mild to very severe menopausal symptoms and meet the eligible
criteria were included in the study. Then they were individually interviewed by the
researcher to collect the basic data using (tool I &II) and randomly assigned into
either Soya group (40) or Pilates group (40).
Oral consents were taken from the women to participate in the study.
IV. The phase of implementation:
For Soya group (SG): among this study group each subject was individually
interviewed then each subject was provided with two packages each one containing 136
soy isoflavones capsules for 12 weeks of the intervention. The subjects were instructed to
consume 3 capsules daily (after meals).
Follow up for women of the (SG) on phone and visit to follow their compliance
with capsules consumption at frequent interval (day after day) was done and were
asked about the presence of any side effects associated with the capsules intake.
For Pilates group (PG)
Based on the data collected from the assessment phase and extensive review of
literature, A Pilate‟s exercise program contents priorities and expected outcomes
were developed by the researcher. The program was adopted and was modified in
accordance with the participants‟ capabilities.
Different teaching strategies were used including videos, posters, demonstrated &
re-demonstration using verbal and visual instructions to conduct the exercises. The
exercise was performed as group training and supervised by the researcher.
The Pilates integrated exercise program comprised of 24 sessions each lasting 30-45
minutes in average or longer), held two sessions a week for 12 weeks in succession
for every woman.
Only the initial session lasted 60 minutes, at the beginning of this session the
researcher introduced herself to the Pilates group and explained the general
objectives of the program, benefits, principles & time schedule.
Each session in the Pilates exercise program conducted through three phases as
ordered: Warm-up, the main program & cool-down.
(4) 1st phase (Warm-up): 7–10 min. for the, session consisting of 5 minutes general warmup
for major muscle groups and 5 minutes of stretching exercises. Appropriate
coordination of breathing with performance of an exercise is considered; (2) 2nd phase
(the main program): this phase held 30 - 45 min. in average comprised of 6 stretching
and strengthen exercises namely; Side-Lying Bicycle, Pelvic Peel (pelvic tilt),
Hundred, Spine Stretch: Forward and Side, Roll Up and Saw. (3) 3rd phase (cooldown):
was included the same exercises in warming up phase and continued for 5–7
min.
Each exercise was repeated 5–10 times for 2–5 sets, with a 10-sec rest per repetition
and 60 sec. between sets.
V. The evaluation phase:
Menopausal symptoms were re-assessed for both groups at the end of the 12th
week using tool II.
Results of the study revealed that:
The results of the present study revealed that there were no statistical significant
differences in the study subjects‟ basic & clinical data which included age, marital status,
level of education, menstrual & menopausal and reproductive history.
Main findings
Regarding physical activity, nearly three-fifths (65% & 62%) of Soya and Pilates
groups respectively carried out light activities. Further, one-quarter (25%) of them
perform moderate physical activity while one-tenth and more (10% & 12.5%) of
Soya and Pilates groups respectively carried out vigorous daily activities.
There was no statistical significant difference between both groups in relation to
daily dietary intake.
Exposure to stress was reported by the vast majority of Soya and Pilates groups
(95% & 87.5%) respectively.
Knowledge about soybeans was reported by around three-fifths (62.5%) of Soya
group compared to more than two-fifths (45%) of Pilates group.
Severity of menopausal symptoms subscale among Soya &Pilates groups
There were statistically significant differences between Soya and Pilates groups in all
menopausal symptoms’ subscale before and after intervention in favor of the former. As
for somatic symptoms, more than one-third (37.5%) of Soya group had reported either
absence (2.5%) and presence of mild (35%) symptoms after intervention compared to
only 2.5% of Pilates group who had mild symptoms. Moreover, a statistically significant
improvement in somatic symptoms was noticed within Soya group P=(0.000) where,
only 15% of them had reported severe symptoms after intervention compared to those of
Pilates group who had either severe (45%) or very severe (32.5%) symptoms.
Regarding psychological symptoms, more than one-half (52.50%) of Soya group had
mild symptoms after intervention compared to only 25% of Pilates group. In addition,
this was evident in the fact that psychological symptoms had improved among Pilates
group where, severe psychological symptoms had declined from 32.5 % to 17.5% but no
statistically significant difference P= (0.148) were observed within the Pilates group.
As for urogenital symptoms, there was a statistically significant difference between
Soya and Pilates groups in favor of the former (P= 0.000) where, Soybean
isoflavone‟s effectiveness was evident in abolishing menopausal urogenital
symptoms completely among more than one-third (37.5%) of Soya group compared
to only % 5 of Pilates group.
Total score of menopausal symptoms
A highly statistically significant difference among Soya group before and after
intervention was found (P=0.000) compared to no statistically significant difference
among Pilates group (P=0.088).
After intervention, there was a highly statistically significant difference between
Soya and Pilates groups (P=0.000), where a sizeable proportion of the former group
(67.5%) experienced mild symptoms compared to only 20% of the latter group.
It was concluded that:
Results support the hypothesis that menopausal women who consume soybean
isoflavones capsules exhibit less severity of menopausal symptoms in relation to somatic,
psychological and urogenital symptoms than those who undergo Pilates exercise program.
Based on the findings of the present study, the following recommendations are
suggested:
Incorporate intake of soy isoflavones as one of herbal remedy within clinical
nursing curricula, so that students will be trained to consider it as an integral
component of health education provided to menopausal women in different nursing
educational institutions.
Extensive training for maternity nurses about management of menopausal
symptoms with complementary & alternative therapies especially soybean and
clarify simple information about its: properties, benefits, doses & uses.
Educational programs should be carried out for menopausal women and their
caregivers about non-pharmacological measures (soybean isoflavones and Pilates
exercise program) to alleviate menopausal symptoms and minimize using of
hormonal replacement therapy.
Further studies:
- Replicate the study on a lager sample size and different settings for the purpose of
better generalization.
- Compare intake of soy isoflavones with other alternative therapy such as: black
cohosh, ginseng and flaxseed in alleviating menopausal symptoms.