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

NCT05324956 | Unknown

• 1 other identifier: 2021/348
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Women

Keywords

Osteopenia; Osteoporosis; Spirometry; 6 Minute Walk Test; New York Posture Rating Chart

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  at baseline

Study Arms (1)

Postmenopausal Women

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

Other: No intervention

Interventions

No intervention OTHER

Individuals will not receive any interventions

Postmenopausal Women

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women aged between 40-80 years old and diagnosed with osteoporosis or osteopenia

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Öykünur CANSU

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Öykünur Cansu

CONTACT

+902324930000; 6009121@bakircay.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

TU (1)