Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women
1 other identifier
interventional
40
1 country
1
Brief Summary
the present study examined the effect of different types of exercises for improving the age-related hyperkyphotic curve of postmenopausal women and also examined how it affects diaphragmatic excursion and respiratory function. Increasing the respiratory functions for elderly will act as a preventive method against nowadays chest diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
September 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJanuary 9, 2024
January 1, 2024
3 months
September 17, 2023
January 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
flexicurve ruler
A flexible curve ruler was used to measure the kyphosis angle. The adjustable curve is one of the non-invasive methods for kyphosis and lordosis angle assessments in the sagittal plan.
period of treatment is for 12 weeks
Diaphragmatic excursion
To measure diaphragmatic excursion, an ultrasonography device was applied with a probe frequency of 2-5 MHz. The right hemi-diaphragmatic excursion was assessed during deep inspiration and deep expiration
period of treatment is for 12 weeks
Quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-41)
The QUALEFFO-41 is a self-administered, disease specific questionnaire used frequently in clinical research. It possesses five domains (41 items in total): pain (5 items), physical function (17 items), social function (7 items), general health perception (3 items) and mental function (9 items). The total QUALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100. The worse the HRQOL condition is, the higher the score gets. The actual score was calculated by the summation of all questions answers, the lowest possible score was 41, the score range was 164 (41 subtracted from 205)
period of treatment is for 12 weeks
Pain assessment scale
Visual analogue scale (VAS) is the most common pain scale for quantification of endometriosis-related pain and skin graft donor site-related pain. A review came to the conclusion that VAS was one of the best adapted pain scales for pain measurement for research purposes.The scale described by the researcher to patients in order to make its use easy. The patients will chose a value from numerized values from 0-10 printed on the scale, 0 (indicates no pain) while 10 (indicates maximum pain) and in between the values are classified.
period of treatment is for 12 weeks
Study Arms (2)
control group
EXPERIMENTALThis group consists of 20 postmenopausal women suffering from thoracic hyper kyphosis. They receive daily session of 30minutes even by therapist or at home for 12 weeks. the corrective exercises for the thoracic spine consist of strengthening exercises for back muscles and stretching exercises for pectoral muscles
interventional group
EXPERIMENTALThis group consists of 20 postmenopausal women suffering from thoracic hyper kyphosis, who receive the corrective exercises prescribed above in addition to resisted diaphragmatic breathing exercise. They receive daily session of 30minutes even by therapist or at home for 12 weeks.
Interventions
corrective exercises: 1. Strengthening exercises : 1. Thoracic extension exercises: * Mckanzie's thoracic extension exercise: * Thoracic spine stretching position 2. Back extension exercise 3. Abdominal curl up exercise 4. Scapular retraction exercises 5. Trunk rotation exercise 2. Stretching exercises: 1. Pectoral muscles stretch from sitting 2. self-stretch for pectoral muscle infront of door
1. Diaphragmatic breathing exercise: From the supine position, overlapping hands on the diaphragm located in the abdominal region: each woman took deep inspiring by the nose and exhaling through the mouth with lips half-closed slowly. 2. Resisted diaphragmatic breathing exercise: From the supine position, with a weight of 1 kg on the diaphragm located in the abdominal region: each woman took deep inspiring by the nose and exhaling through the mouth with lips half-closed slowly
Eligibility Criteria
You may qualify if:
- All postmenopausal women suffering from thoracic kyphosis.
- Their thoracic kyphosis (Cobb's) angles were more than 45 degrees.
- Their age ranged from 50-60 years old.
- Their BMI were \>25 and \<30 kg/m2.
You may not qualify if:
- All patients with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
- Patients with previous trauma to the spine, pelvis and lower limbs.
- Patients with a previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or kyphoplasty).
- Patients with congenital spinal deformities and scoliosis.
- Patients with a history of spinal tumors, ankylosing spondylitis, osteoporosis and other spondyloarthritis.
- The patients received medications that might affect the neuromuscular functions at least three months before or during the study course.
- Patients suffered from mental or psychological disorders.
- Patients suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
faculty of physical therapy, Cairo university
Giza, 12662, Egypt
Study Officials
- STUDY CHAIR
Fahima okeel
Cairo University
- STUDY DIRECTOR
Amal Yousef
Cairo University
- PRINCIPAL INVESTIGATOR
Khaled Kamel
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 17, 2023
First Posted
September 28, 2023
Study Start
September 30, 2023
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
January 9, 2024
Record last verified: 2024-01