Hot FlashesNCT05892094
Comparison of the Effect of Exercises on Vasomotor Symptoms in Middle Aged Women
A study testing Resistance and Aerobic Training in people with Hot Flashes and Menopause, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- Resistance and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Koc University Hospital
Istanbul, 34010
Istanbul Medipol University
Istanbul, 34820
About this study
Official title: Comparison of the Effect of Resistance and Aerobic Training on Vasomotor Symptoms in Women in the Climacteric Period
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.
Read the 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.
- Conditions
- Hot Flashes, Menopause
- Being tested
- Resistance and Aerobic Training
- Keywords
- Exercise, Hot flashes, Menopause, Resistance training, Aerobic exercise, Vasomotor symptoms, Quality of life, Sleep quality
- Medical subject headings
- Hot Flashes, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and Aerobic TrainingOther
For aerobic exercise, participants will do brisk walking 30 minutes in the first two weeks, 3-6. weeks will be 35 minutes, 7th and 8th weeks will be 40 minutes.The first and last 10 minutes of each walk will be said to be done at a slow pace, for the warm-up and cool-down periods. Participants will be called regularly to monitor their participation in the aerobic exercise program, and their compliance with the exercise will be checked, and they will be motivated to continue the exercises by providing the necessary information. Resistance exercises sessions will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. The training load will be provided by progressively increasing the repetitions. The Borg Scale will be used to adjust the exercise intensity. Rest time between sets will be 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants will participate in a 12-week full-body resistance and aerobic exercise program. It will include full body resistance exercises two days a week and aerobic exercise program three days a week. For aerobic exercise, participants will be asked to do brisk walking 3 days a week. Participants will be called regularly to monitor their participation in the aerobic exercise program. Resistance exercises sessions will be supervised by a physical therapist. Each resistance training session will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. Resistance exercises will consist of weight-bearing exercises performed with the participant's own body weight. Participants in the exercise group will complete the questionnaires at baseline and after 12 weeks at the end of the intervention. Receives: Other: Resistance and Aerobic Training |
| Control Group | No intervention | Participants in the control group were instructed not to change their physical activity habits during 15 weeks and to avoid any other treatment for vasomotor symptoms. Participants in the control group will complete the questionnaires at baseline and after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vasomotor sypmtoms
It will be assessed with vasomotor domain of the The Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL assesses the impact of the menopausal symptoms and one of the four domains is vasomotor symptoms.
Measured: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Change in the Menopause-specific Quality of Life (MENQOL) Questionnaire
The MENQOL is a validated questionnaire for the assessment of menopausal women's symptoms and an effective instrument. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual.
Measured: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Change in the Menopause Rating Scale (MRS)
MRS is a health-related quality of life scale (HRQoL) and was developed in response to the lack of standardized scales to measure the severity of aging-symptoms and their impact on the HRQoL. The MRS consists of a list of 11 items. Each of the eleven symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale.
Measured: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Secondary outcomes (1)
Change in the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Measured: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start15 Jun 2023
- Primary completion23 Jan 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem yilmaz, Istanbul Medipol University Hospital
- Investigators
- Gizem Yılmaz, RA, Principal investigator, Medipol UniversityZeliha Candan Algun, PhD, Principal investigator, Medipol UniversityAhmet Fatih Durmuşoğlu, PhD, MD, Principal investigator, Medipol UniversitySebile Güler Çekiç, PhD, MD, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892094
- Sponsor's protocol ID
- E-10840098-772.02-754
- Status last verified
- Feb 2024
- First submitted
- 17 May 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz Babacan G, Guler Cekic S, Algun ZC, Durmusoglu AF. Effects of exercise training on vasomotor symptoms and quality of life in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2025 Dec 22;25(1):612. doi: 10.1186/s12905-025-04231-y.
PubMed 41430672
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Resistance and Aerobic Training on Vasomotor Symptoms in Women in the Climacteric Period
- ClinicalTrials.gov ID
- NCT05892094
- Acronym / sponsor ID
- E-10840098-772.02-754
- Conditions
- Hot Flashes, Menopause
- Keywords
- Exercise, Hot flashes, Menopause, Resistance training, Aerobic exercise, Vasomotor symptoms, Quality of life, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Resistance and Aerobic TrainingParticipants will participate in a 12-week full-body resistance and aerobic exercise program. It will include full body resistance exercises two days a week and aerobic exercise program three days a week. For aerobic exercise, participants will be asked to do brisk walking 3 days a week. Participants will be called regularly to monitor their participation in the aerobic exercise program. Resistance exercises sessions will be supervised by a physical therapist. Each resistance training session will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. Resistance exercises will consist of weight-bearing exercises performed with the participant's own body weight. Participants in the exercise group will complete the questionnaires at baseline and after 12 weeks at the end of the intervention. |
| Control Group | No intervention | –Participants in the control group were instructed not to change their physical activity habits during 15 weeks and to avoid any other treatment for vasomotor symptoms. Participants in the control group will complete the questionnaires at baseline and after 12 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance and Aerobic TrainingFor aerobic exercise, participants will do brisk walking 30 minutes in the first two weeks, 3-6. weeks will be 35 minutes, 7th and 8th weeks will be 40 minutes.The first and last 10 minutes of each walk will be said to be done at a slow pace, for the warm-up and cool-down periods. Participants will be called regularly to monitor their participation in the aerobic exercise program, and their compliance with the exercise will be checked, and they will be motivated to continue the exercises by providing the necessary information. Resistance exercises sessions will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. The training load will be provided by progressively increasing the repetitions. The Borg Scale will be used to adjust the exercise intensity. Rest time between sets will be 60 seconds. | Other | Exercise Group |
Primary outcome
Change in vasomotor sypmtoms
Time frame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
It will be assessed with vasomotor domain of the The Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL assesses the impact of the menopausal symptoms and one of the four domains is vasomotor symptoms.
Change in the Menopause-specific Quality of Life (MENQOL) Questionnaire
Time frame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
The MENQOL is a validated questionnaire for the assessment of menopausal women's symptoms and an effective instrument. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual.
Change in the Menopause Rating Scale (MRS)
Time frame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
MRS is a health-related quality of life scale (HRQoL) and was developed in response to the lack of standardized scales to measure the severity of aging-symptoms and their impact on the HRQoL. The MRS consists of a list of 11 items. Each of the eleven symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale.
1 secondary outcome
Change in the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (Before intervention) and at the end of the intervention after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 41430672Yilmaz Babacan G, Guler Cekic S, Algun ZC, Durmusoglu AF. Effects of exercise training on vasomotor symptoms and quality of life in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2025 Dec 22;25(1):612. doi: 10.1186/s12905-025-04231-y.
Related trials for Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Yılmaz, RA principal investigator
Medipol University
Zeliha Candan Algun, PhD principal investigator
Medipol University
Ahmet Fatih Durmuşoğlu, PhD, MD principal investigator
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance and Aerobic Training in people with Hot Flashes and Menopause, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vasomotor sypmtoms (time frame: Baseline (Before intervention) and at the end of the intervention after 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.