The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity

NCT ID: NCT05324956

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-30

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Postmenopausal Women

Postmenopausal women be between 40-79 years and being diagnosed with osteoporosis or osteopenia

No intervention

Intervention Type OTHER

Individuals will not receive any interventions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Individuals will not receive any interventions

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 40-80 years old
* Female gender
* Being diagnosed with menopause
* Being diagnosed with osteoporosis or osteopenia
* Volunteer to participate in the study

Exclusion Criteria

* 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
* 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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Öykünur CANSU

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Öykünur CANSU

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Öykünur Cansu

Role: CONTACT

+902324930000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/348

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteosarcopenia and Exercise
NCT04526327 COMPLETED NA
Osteoporosis After Stroke
NCT07059468 NOT_YET_RECRUITING