Clinical trial NCT05892094: Comparison of the Effect of Exercises on Vasomotor Symptoms in Middle Aged Women
Official title: Comparison of the Effect of Resistance and Aerobic Training on Vasomotor Symptoms in Women in the Climacteric Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Menopause
Keywords: Exercise
Hot flashes
Menopause
Resistance training
Aerobic exercise
Vasomotor symptoms
Quality of life
Sleep quality
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 36
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 40-65
* Those who report moderate or severe vasomotor symptoms
* Those who have not received hormone replacement therapy for at least 3 months
* Maximum of 225 minutes of physical activity per week

Exclusion Criteria:

* Receiving medical treatment for menopausal symptoms in the past 2 months
* Any medical condition or physical inability to participate in exercise training
* Systolic blood pressure \>160 mmHg
* Diastolic blood pressure \>100 mmHg

Primary outcomes:
measure: Change in vasomotor sypmtoms
timeFrame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
measure: Change in the Menopause-specific Quality of Life (MENQOL) Questionnaire
timeFrame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
measure: Change in the Menopause Rating Scale (MRS)
timeFrame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Secondary outcomes:
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Gizem Yılmaz, RA
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Zeliha Candan Algun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Ahmet Fatih Durmuşoğlu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University
name: Sebile Güler Çekiç, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: