Postmenopausal WomenNCT05324956
The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity
An observational study of Postmenopausal Women, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
If the bone mineral density of a patient with a diagnosis of osteopenia falls further, he develops osteoporosis.Menopause causes many changes in women's bodies in the form of vasomotor, sleep disorders, fatigue, aches and pains, altered cognitive functions, as well as genitourinary problems such as vaginal dryness… Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2022to Jun 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women aged between 40-80 years old and diagnosed with osteoporosis or osteopenia
Who may be able to join
- Between 40-80 years old
- Female gender
- Being diagnosed with menopause
- Being diagnosed with osteoporosis or osteopenia
- Volunteer to participate in the study
Who cannot join
- Hemoptysis of unknown cause
- Recent abdominal, thoracic, or eye surgery
- Thoracic, abdominal, or cerebral aneurysm
- pulmonary embolism
- Mental state disorder that interferes with cooperation
- Arrhythmias disrupting hemodynamics
Show all 13Show fewer
- Having any diagnosed disease affecting the respiratory system
- pneumothorax
- unstable angina
- Recent myocardial infarction
- Thrombosis in lower extremity
- Acute myocarditis
- Other diseases that will prevent exercise (infection, kidney failure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity in Postmenopausal Women
If the bone mineral density of a patient with a diagnosis of osteopenia falls further, he develops osteoporosis.Menopause causes many changes in women's bodies in the form of vasomotor, sleep disorders, fatigue, aches and pains, altered cognitive functions, as well as genitourinary problems such as vaginal dryness, irritation, recurrent urinary tract infections. In the long term, inevitable changes occur in the musculoskeletal system. Osteoporosis, sarcopenia, postural dysfunction, regression in gait cycle, Loss of balance control and instability and increased risk of falling are the changes reported during this period. These mentioned effects negatively affect the quality of life of women. The aim of this study is to investigate the relationship of bone mineral density with respiratory functions and exercise capacity in postmenopausal women.The second aim is to compare the respiratory functions and exercise capacities of postmenopausal women with osteopenia and osteoporosis.
Read the detailed description
The 1993 Consensus Development Conference paper defined osteoporosis as ''a disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and consequent increased risk of fracture.In 1994, the World Health Organization (WHO) established criteria for measuring bone mineral density (BMD) that allowed the diagnosis of osteoporosis before fractures. This practical definition is based on the main (known) risk factor: reduced bone strength or density and people at high risk but without fractures.Premenopausal women have a low rate of osteoporosis; however, the prevalence increases with age due to progressive bone loss.Bone densitometry is an established method for evaluating osteoporosis. Various different methods have been developed in the last 25 years. DEXA is recommended and FDA approved for BMD measurement; It is precise, noninvasive, has low radiation exposure and takes 10 minutes to administer. Osteoporosis can have a significant impact on patients' daily lives. Vertebral deformity causes loss of spinal mobility, and patients with osteoporosis have difficulty standing, bending over, getting up from a chair, walking, carrying objects, dressing, fixing hair, bathing, moving in bed, using the toilet, and descending to the floor. Compared with women without existing vertebral deformities, women with extensive deformities have higher crude mortality and hospitalization rates overall.Osteoporosis deprives older women of many of their social roles. Failure to fulfill roles such as cooking, housework, work, and intimacy can be devastating, leading to frustration and embarrassment. Interpersonal relationships can be deeply affected by the effects of osteoporosis, straining family ties and destroying extra-familial relationships, leading to social isolation. Therefore, treatment options should be well evaluated because affected individuals should focus not only on bone remodeling, but also on ways in which negative outcomes such as pain, depression and loss of self-esteem can be improved. Considering all these situations, we asked the question whether there is any relationship between bone mineral density and respiratory functions and exercise capacity. In order to evaluate these parameters, we decided to examine the patient's detailed demographic information, posture evaluation according to the New York Posture Scale, 6-minute walking test result, and Pulmonary Function Test result.
- Conditions
- Postmenopausal Women
- Being tested
- No intervention
- Keywords
- Osteopenia, Osteoporosis, Spirometry, 6 Minute Walk Test, New York Posture Rating Chart
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Individuals will not receive any interventions
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Women | Postmenopausal women be between 40-79 years and being diagnosed with osteoporosis or osteopenia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Respiratory Functions
Spirometry will be applied to evaluate respiratory functions.It is the most commonly performed lung function test, which evaluates volume against time using a device called a spirometer. The expiratory time should be at least 6 seconds and extended up to 15 seconds if necessary.The patient is instructed to take a deep breath and blow as hard and as fast as possible and take a deep breath to complete the flow volume cycle. The one with the highest values out of at least three tests done in succession is selected.
Measured: at baseline
Evaluation of Exercise Capacity
6 Minutes Walking Test will be applied to evaluate exercise capacity. The goal of this test is to walk the maximum distance that can be walked in 6 minutes. Average walking distances: 20/50 age:590-640m 60/70 age:540/570m 70/80 age:470-530m.
Measured: at baseline
Posture Assessment
Posture assessment will be made using the New York Posture Rating Chart (NYPR).NYPR is an inexpensive, easy and fast-applied subjective postural assessment method that is widely used for clinical postural assessment. The grading chart is used to evaluate 13 areas of the body based on the assumption that posture is the alignment of the body and its parts.Each field is awarded a point based on position: 5 points for correct position; 3 points for a slight deviation and 1 point for a significant deviation. The total score ranges from 18-90 points. The higher the score, the better the postural alignment.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öykünur CANSU, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324956
- Sponsor's protocol ID
- 2021/348
- Status last verified
- Apr 2022
- First submitted
- 22 Feb 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05324956
- Acronym / sponsor ID
- 2021/348
- Conditions
- Postmenopausal Women
- Keywords
- Osteopenia, Osteoporosis, Spirometry, 6 Minute Walk Test, New York Posture Rating Chart
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Apr 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.
If the bone mineral density of a patient with a diagnosis of osteopenia falls further, he develops osteoporosis.Menopause causes many changes in women's bodies in the form of vasomotor, sleep disorders, fatigue, aches and pains, altered cognitive functions, as well as genitourinary problems such as vaginal dryness, irritation, recurrent urinary tract infections. In the long term, inevitable changes occur in the musculoskeletal system. Osteoporosis, sarcopenia, postural dysfunction, regression in gait cycle, Loss of balance control and instability and increased risk of falling are the changes reported during this period. These mentioned effects negatively affect the quality of life of women. The aim of this study is to investigate the relationship of bone mineral density with respiratory functions and exercise capacity in postmenopausal women.The second aim is to compare the respiratory functions and exercise capacities of postmenopausal women with osteopenia and osteoporosis.
Detailed description
The 1993 Consensus Development Conference paper defined osteoporosis as ''a disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and consequent increased risk of fracture.In 1994, the World Health Organization (WHO) established criteria for measuring bone mineral density (BMD) that allowed the diagnosis of osteoporosis before fractures. This practical definition is based on the main (known) risk factor: reduced bone strength or density and people at high risk but without fractures.Premenopausal women have a low rate of osteoporosis; however, the prevalence increases with age due to progressive bone loss.Bone densitometry is an established method for evaluating osteoporosis. Various different methods have been developed in the last 25 years. DEXA is recommended and FDA approved for BMD measurement; It is precise, noninvasive, has low radiation exposure and takes 10 minutes to administer. Osteoporosis can have a significant impact on patients' daily lives. Vertebral deformity causes loss of spinal mobility, and patients with osteoporosis have difficulty standing, bending over, getting up from a chair, walking, carrying objects, dressing, fixing hair, bathing, moving in bed, using the toilet, and descending to the floor. Compared with women without existing vertebral deformities, women with extensive deformities have higher crude mortality and hospitalization rates overall.Osteoporosis deprives older women of many of their social roles. Failure to fulfill roles such as cooking, housework, work, and intimacy can be devastating, leading to frustration and embarrassment. Interpersonal relationships can be deeply affected by the effects of osteoporosis, straining family ties and destroying extra-familial relationships, leading to social isolation. Therefore, treatment options should be well evaluated because affected individuals should focus not only on bone remodeling, but also on ways in which negative outcomes such as pain, depression and loss of self-esteem can be improved. Considering all these situations, we asked the question whether there is any relationship between bone mineral density and respiratory functions and exercise capacity. In order to evaluate these parameters, we decided to examine the patient's detailed demographic information, posture evaluation according to the New York Posture Scale, 6-minute walking test result, and Pulmonary Function Test result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Women | – | Other: No interventionPostmenopausal women be between 40-79 years and being diagnosed with osteoporosis or osteopenia |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women aged between 40-80 years old and diagnosed with osteoporosis or osteopenia
Key inclusion criteria (5 listed)
- Between 40-80 years old
- Female gender
- Being diagnosed with menopause
- Being diagnosed with osteoporosis or osteopenia
- Volunteer to participate in the study
Key exclusion criteria (13 listed)
- Hemoptysis of unknown cause
- Recent abdominal, thoracic, or eye surgery
- Thoracic, abdominal, or cerebral aneurysm
- pulmonary embolism
- Mental state disorder that interferes with cooperation
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 |
|---|---|---|
| No interventionIndividuals will not receive any interventions | Other | Postmenopausal Women |
Primary outcome
Evaluation of Respiratory Functions
Time frame: at baseline
Spirometry will be applied to evaluate respiratory functions.It is the most commonly performed lung function test, which evaluates volume against time using a device called a spirometer. The expiratory time should be at least 6 seconds and extended up to 15 seconds if necessary.The patient is instructed to take a deep breath and blow as hard and as fast as possible and take a deep breath to complete the flow volume cycle. The one with the highest values out of at least three tests done in succession is selected.
Evaluation of Exercise Capacity
Time frame: at baseline
6 Minutes Walking Test will be applied to evaluate exercise capacity. The goal of this test is to walk the maximum distance that can be walked in 6 minutes. Average walking distances: 20/50 age:590-640m 60/70 age:540/570m 70/80 age:470-530m.
Posture Assessment
Time frame: at baseline
Posture assessment will be made using the New York Posture Rating Chart (NYPR).NYPR is an inexpensive, easy and fast-applied subjective postural assessment method that is widely used for clinical postural assessment. The grading chart is used to evaluate 13 areas of the body based on the assumption that posture is the alignment of the body and its parts.Each field is awarded a point based on position: 5 points for correct position; 3 points for a slight deviation and 1 point for a significant deviation. The total score ranges from 18-90 points. The higher the score, the better the postural alignment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Postmenopausal Women, run by Izmir Bakircay University at 1 site 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Öykünur Cansu (+902324930000, 6009121@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Respiratory Functions (time frame: at baseline). 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?
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 13 Apr 2022.