Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05892094 |
| Other study ID # |
E-10840098-772.02-754 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
February 14, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Istanbul Medipol University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Vasomotor symptoms (VMS) develop in the premenopausal period and symptoms may persist for
years after menopause.Vasomotor symptoms such as hot flashes, night sweats, mood swings and
sleep disturbances affect women's quality of life. There is a need for alternative treatments
to reduce vasomotor symptoms due to the inadequacy of current treatments and the need for an
effective treatment. Exercise is seen as a low-risk treatment to reduce vasomotor symptoms.
Resistance trainig combined with aerobic training may be effective in reducing vasomotor
symptoms and improving quality of life. The effects of the combination of resistance trainig
2 days a week and aerobic trainig 3 days a week on vasomotor symptoms, quality of life, sleep
disturbance and depression will be investigated and compared with the control group.
Description:
The climacterium, which is seen in the transition of women from the fertile period to the
life stage where they lose their fertility, is seen as a natural process of aging. The World
Health Organization (WHO) defines menopause as "the permanent cessation of menstruation as a
result of loss of ovarian activity". The diagnosis of menopause in women is made
retrospectively, usually one year after the cessation of menstrual bleeding between the ages
of 45-55. The climacteric period, which consists of four phases: premenopause, menopause,
perimenopause and postmenopause, covers a period of time starting around the age of 40-45 and
extending to the age of 65. The premenopausal period covers the period from the onset of
menstrual irregularities and the first symptoms to menopause. The first symptoms in the
premenopausal period can be seen 4 years before the cessation of menstrual bleeding.
Perimenopause (transition to menopause) covers premenopause, menopause and the one-year
period after menopause. The postmenopausal stage, on the other hand, takes place in a long
period of time from one year after menopause in women to old age. During the climacteric
period, women may experience various symptoms. Vasomotor symptoms (VMS), including both
daytime hot flashes and night sweats during sleep, can be experienced by middle-aged women
with regular menstrual cycles, with a prevalence peaking at approximately 79% in late
perimenopause. Vasomotor symptoms affects approximately 60% to 80% of women report that they
feel discomfort due to vasomotor symptoms and negatively affect their quality of life. In
women, these symptoms last up to 1-2 years after menopause. However, some women may
experience symptoms for 10 years or longer. Vasomotor episodes are usually felt as
spontaneous warmth on the chest, neck, and face of women, and this condition has often been
found to be associated with sweating, anxiety, and palpitations. These symptoms can be seen
as hot flashes, night sweats and facial flushing. Vasomotor symptoms interrupt women's work
and daily activities and may cause sleep problems that require medical treatment. Although
the cause of vasomotor symptoms is not known exactly, it is thought to develop due to
hormonal changes.
Exercise is seen as a low-risk treatment to reduce vasomotor symptoms, but the evidence in
the literature is inconclusive. Some observational studies have reported less VMS in
physically active postmenopausal women than in sedentary women. Results from intervention
studies are of low quality. The World Health Organization recommends resistance exercise
twice a week for all adults. The American College of Sports Medicine (ACSM) recommends at
least two days a week of resistance exercise, as well as aerobic activities three days a
week. Exercise training is especially important in postmenopausal women, where decreases in
muscle strength, bone mineral density and basal metabolic rate are accelerated. Previous
studies, although limited, have focused on the effect of resistance training on vasomotor
symptoms. In our current study, the effects of aerobic activity combined with resistance
exercises on vasomotor symptoms, quality of life, sleep disturbance and depression will be
investigated and compared with the control group.
