Menopausal WomenClimWoNCT05505266
Physical and Emotional Coping Variables in Climacteric Women
An observational study of Menopausal Women, run by University of Valencia at 1 site in Spain.
Trial summary
Introduction: The transition to menopause entails several changes in the biopsychosocial sphere of climacteric women. Compared to other therapies, physical exercise has no side effects, is not costly and can have a positive influence on the symptoms reported by women at this stage. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- What is being tested?
- observational
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 11 Nov 2022
- Phase
- Observational
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Climacteric women
Who may be able to join
- Climacteric women
- Age between 40 and 60 years.
Who cannot join
- Not having internet access to complete the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity, Quality of Life, Emotional State and Coping Strategies in Climacteric Women.
Introduction: The transition to menopause entails several changes in the biopsychosocial sphere of climacteric women. Compared to other therapies, physical exercise has no side effects, is not costly and can have a positive influence on the symptoms reported by women at this stage. The emotional and physical state of climacteric women is affected by the alterations typical of menopause, deteriorating their quality of life. Likewise, physical exercise improves the associated symptomatology. The objective is to know how the study variables (symptomatology, quality of life, emotional state, physical exercise and level of coping) correlate.
Material and methods: Cross-sectional descriptive observational design with a study population made up of women in the climacteric stage carried out through an anonymous and voluntary survey.
Read the detailed description
The climacteric is a progressive period, which lasts for years, before and after menopause, the latter being the physiological stage of aging characterized by the decrease in the follicular function of the ovaries that ends with the cessation of menstrual periods. permanent, a phenomenon associated with the decrease in the production of hormones, as well as the arrest by the ovaries in the release of ovules. Menopause most commonly occurs between the ages of 45 and 55. The climacteric is experienced by each woman in a different way, since it is also influenced by biopsychosocial factors, but the investigators can speak of a common symptomatology typical of the climacteric that groups together vasomotor symptoms such as hot flashes and palpitations, psychological symptoms such as changes in mood, depression, irritability and anxiety, alterations in sleep quality, cognitive symptoms such as memory loss, among others. Among the therapies to alleviate the symptoms associated with menopause, the investigators find estrogenic and non-estrogenic hormonal therapies, inhibitors and physical exercise.
Despite the lack of evidence to support physical exercise as a tool to eradicate symptoms linked to menopause, the investigators can affirm that it relieves both somatic and psychological symptoms, and vasomotor and sexual symptoms to a lesser extent, which is associated with an improvement overall quality of life. In addition, with regular physical activity the investigators will be able to strengthen the musculoskeletal system and improve the quality of life.
The investigators found a scarcity of studies that relate therapeutic exercise as a physiotherapeutic tool in relieving the symptomatology of climacteric women, for this reason the need to study the activity they carry out in this area and know its characteristics is raised, in order to guide future strategies in physiotherapy.
Objective: To know the physical exercise carried out by women in this period, to know the existence of levels of anxiety and depression, Coping level and quality of life.
Material and methods Subjects: Women between 40 and 60 years old. For the development of the study, a questionnaire is prepared, which consists of an initial section with basic questions about personal data and symptomatology referred to by each subject, to later move on to the rest of the sections that will include questions from other validated questionnaires: quality of life using the SF -12; For the emotional state, the Goldberg scale; For physical activity, the International Physical Activity Questionnaire (IPAQ); And for coping level, the Brief COPE inventory.
At the end, 2 questions are included about how often they go to a physical therapist to deal with musculoskeletal pain.
Once the questionnaire is closed, the results will be analyzed using SPSS, which will allow us to contrast hypotheses and generate new ones.
- Conditions
- Menopausal Women
- Being tested
- observational
- Keywords
- climateric women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
It is evaluated using the International Physical Activity Questionnaire (IPAQ). This questionnaire in its short version consists of 7 questions about the frequency, duration and intensity of physical activity performed during the last 7 days and is designed to be used with adults between the ages of 18 and 65. The aim is thus to monitor the time spent for each type of activity. Weekly physical activity will be quantified in Metabolic Rate Units (METs) per minute and per week. The reference values used in this questionnaire mark 3.3 METs for walking, 4 METs for moderate physical activity and 8 METs for intense physical activity. These amounts must be multiplied by the time in minutes and by the number of days used to carry out each of the different exercise modalities according to their value. The IPAQ classifies the level of physical activity performed into 3 categories: low, medium and high.
Measured: 1 day
Secondary outcomes (3)
Well-being
It is evaluated using the SF-12 questionnaire. This questionnaire thus provides an instrument to assess the functional capacity and level of well-being of people over 14 years of age, in order to define a positive or negative state of physical and mental health, testing for each of them 4 dimensions, resulting in a total of 8 different dimensions in the entire questionnaire, which are mentioned below: for physical health; physical function, physical role, bodily pain and general health and for mental health; social function, emotional role, mental health and vitality. The response modality for each of the questions is Likert-type, that is, the scales have between 3 and 6 points, depending on the number of options. They aim to assess the intensity and/or frequency of the degree of health of the women surveyed. The total score of the questionnaire is collected between the values 0 and 100, being a high score equivalent to a better health condition of the person.
Measured: 1 day
Anxiety and depression
It is evaluated using the Goldberg Anxiety and Depression Scale (GADS). In the test, questions are asked that refer to the state of mind of the last 2 weeks, with questions about the symptoms mentioned, specifically, 4 will be specific to anxiety and another 4 specific to depression. Given 2 or more affirmative answers in the anxiety section, another 5 questions about anxiety will be asked and, following the same line, if 1 or more positive answers are obtained in the depression section, the test will end with 5 more questions.This means that, if at least 2 affirmative questions were obtained from the 4 existing anxiety questions and 1 affirmative question from depression questions, we would have that the scale consists of a total of 18 questions, with 9 in each subscale. The cut-off points assigned to classify the existence of anxiety are 4 or more points, which are obtained with each affirmative answer, and 2 or more points to classify depression.
Measured: 1 day
Coping level
It is evaluated through the COPE-28 inventory. This inventory consists of 28 questions, with 2 items for each of the 14 subscales. It has four response alternatives, scored from 0 to 3, which refer to "I never resort to this" to "I always resort to this" with intermediate scores; "almost never" and "frequently". Once the inventory is complete, the score of two items of each subscale will be added. High scores indicate more frequent use of that coping style.
This questionnaire collects the following variables: active coping, emotional support, social support, self-blame, acceptance, self-distraction, relief, behavioral disconnection, humor, denial, planning, positive reinterpretation, religion, and use of substances such as alcohol or medication.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505266
- Sponsor's protocol ID
- ID0037
- Acronym
- ClimWo
- Status last verified
- Nov 2022
- First submitted
- 15 Aug 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Quality of Life, Emotional State and Coping Strategies in Climacteric Women.
- ClinicalTrials.gov ID
- NCT05505266
- Acronym / sponsor ID
- ClimWo / ID0037
- Conditions
- Menopausal Women
- Keywords
- climateric women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 17 Aug 2022 (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.
Introduction: The transition to menopause entails several changes in the biopsychosocial sphere of climacteric women. Compared to other therapies, physical exercise has no side effects, is not costly and can have a positive influence on the symptoms reported by women at this stage. The emotional and physical state of climacteric women is affected by the alterations typical of menopause, deteriorating their quality of life. Likewise, physical exercise improves the associated symptomatology. The objective is to know how the study variables (symptomatology, quality of life, emotional state, physical exercise and level of coping) correlate.
Material and methods: Cross-sectional descriptive observational design with a study population made up of women in the climacteric stage carried out through an anonymous and voluntary survey.
Detailed description
The climacteric is a progressive period, which lasts for years, before and after menopause, the latter being the physiological stage of aging characterized by the decrease in the follicular function of the ovaries that ends with the cessation of menstrual periods. permanent, a phenomenon associated with the decrease in the production of hormones, as well as the arrest by the ovaries in the release of ovules. Menopause most commonly occurs between the ages of 45 and 55. The climacteric is experienced by each woman in a different way, since it is also influenced by biopsychosocial factors, but the investigators can speak of a common symptomatology typical of the climacteric that groups together vasomotor symptoms such as hot flashes and palpitations, psychological symptoms such as changes in mood, depression, irritability and anxiety, alterations in sleep quality, cognitive symptoms such as memory loss, among others. Among the therapies to alleviate the symptoms associated with menopause, the investigators find estrogenic and non-estrogenic hormonal therapies, inhibitors and physical exercise.
Despite the lack of evidence to support physical exercise as a tool to eradicate symptoms linked to menopause, the investigators can affirm that it relieves both somatic and psychological symptoms, and vasomotor and sexual symptoms to a lesser extent, which is associated with an improvement overall quality of life. In addition, with regular physical activity the investigators will be able to strengthen the musculoskeletal system and improve the quality of life.
The investigators found a scarcity of studies that relate therapeutic exercise as a physiotherapeutic tool in relieving the symptomatology of climacteric women, for this reason the need to study the activity they carry out in this area and know its characteristics is raised, in order to guide future strategies in physiotherapy.
Objective: To know the physical exercise carried out by women in this period, to know the existence of levels of anxiety and depression, Coping level and quality of life.
Material and methods Subjects: Women between 40 and 60 years old. For the development of the study, a questionnaire is prepared, which consists of an initial section with basic questions about personal data and symptomatology referred to by each subject, to later move on to the rest of the sections that will include questions from other validated questionnaires: quality of life using the SF -12; For the emotional state, the Goldberg scale; For physical activity, the International Physical Activity Questionnaire (IPAQ); And for coping level, the Brief COPE inventory.
At the end, 2 questions are included about how often they go to a physical therapist to deal with musculoskeletal pain.
Once the questionnaire is closed, the results will be analyzed using SPSS, which will allow us to contrast hypotheses and generate new ones.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Climacteric women
Key inclusion criteria (2 listed)
- Climacteric women
- Age between 40 and 60 years.
Key exclusion criteria (1 listed)
- Not having internet access to complete the questionnaire.
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 |
|---|---|---|
| observationalobservational | Other | – |
Primary outcome
Physical activity
Time frame: 1 day
It is evaluated using the International Physical Activity Questionnaire (IPAQ). This questionnaire in its short version consists of 7 questions about the frequency, duration and intensity of physical activity performed during the last 7 days and is designed to be used with adults between the ages of 18 and 65. The aim is thus to monitor the time spent for each type of activity. Weekly physical activity will be quantified in Metabolic Rate Units (METs) per minute and per week. The reference values used in this questionnaire mark 3.3 METs for walking, 4 METs for moderate physical activity and 8 METs for intense physical activity. These amounts must be multiplied by the time in minutes and by the number of days used to carry out each of the different exercise modalities according to their value. The IPAQ classifies the level of physical activity performed into 3 categories: low, medium and high.
3 secondary outcomes
Well-being
Time frame: 1 day
Anxiety and depression
Time frame: 1 day
Coping level
Time frame: 1 day
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 14 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Women, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 1 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Physical activity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2022.