Clinical trial NCT05324956: The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity
Official title: The Relationship Between Bone Mineral Density With Respiratory Functions and Exercise Capacity in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postmenopausal Women
Keywords: Osteopenia
Osteoporosis
Spirometry
6 Minute Walk Test
New York Posture Rating Chart
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women aged between 40-80 years old and diagnosed with osteoporosis or osteopenia

Brief 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, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of Respiratory Functions
timeFrame: at baseline
measure: Evaluation of Exercise Capacity
timeFrame: at baseline
measure: Posture Assessment
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Öykünur CANSU
Study officials:
References: