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Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women

Primary Purpose

Kyphosis Postural Thoracic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
corrective exercises
resisted diaphragmatic breathing exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kyphosis Postural Thoracic focused on measuring postmenopausal kyphosis, flexicurve ruler, diaphragmatic excursion, corrective exercises, resisted diaphragmatic breathing

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • faculty of physical therapy, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

control group

interventional group

Arm Description

This 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

This 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.

Outcomes

Primary Outcome Measures

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.
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
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)
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2023
Last Updated
September 29, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06057701
Brief Title
Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women
Official Title
Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study was conducted to examine the effect of exercises on diaphragmatic excursion in postmenopausal kyphotic women. Design of study: A prospective, randomized, single-blind, pre-post-test, controlled trial. The study followed the Guidelines of Declaration of Helsinki on the conduct of human research. Ethical approval was obtained from the institutional review board at Faculty of physical therapy, Cairo University before study commencement (no.P.T,REC/012/003800). This study was carried on forty postmenopausal women clinically diagnosed with thoracic kyphosis. They selected randomly from the outpatient clinic of El Kaser El-Einy University Hospital, Cairo University. Their ages ranged from 50-60 years. Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis Postural Thoracic
Keywords
postmenopausal kyphosis, flexicurve ruler, diaphragmatic excursion, corrective exercises, resisted diaphragmatic breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention: Group A: This group was consisted of 20 postmenopausal women suffering from thoracic kyphosis. They received corrective exercises for twice a week for 12 weeks. corrective exercises: The patient did a daily session of 20-30 min (under the supervision of the therapist or alone at home). It consisted of warm up phase for 5 minutes (breathing exercises), active phase (corrective exercises) and cooling down phase finally for return to the initial state. strengthening exercises and stretching exercise Group B: The study group consisted of 20 postmenopausal women suffering from thoracic kyphosis, who received corrective exercises prescribed above in addition to resisted diaphragmatic breathing exercise.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
This 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
Arm Title
interventional group
Arm Type
Experimental
Arm Description
This 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.
Intervention Type
Other
Intervention Name(s)
corrective exercises
Intervention Description
corrective exercises: Strengthening exercises : Thoracic extension exercises: Mckanzie's thoracic extension exercise: Thoracic spine stretching position Back extension exercise Abdominal curl up exercise Scapular retraction exercises Trunk rotation exercise Stretching exercises: Pectoral muscles stretch from sitting self-stretch for pectoral muscle infront of door
Intervention Type
Other
Intervention Name(s)
resisted diaphragmatic breathing exercises
Intervention Description
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. 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
Primary Outcome Measure Information:
Title
flexicurve ruler
Description
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.
Time Frame
period of treatment is for 12 weeks
Title
Diaphragmatic excursion
Description
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
Time Frame
period of treatment is for 12 weeks
Title
Quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-41)
Description
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)
Time Frame
period of treatment is for 12 weeks
Title
Pain assessment scale
Description
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.
Time Frame
period of treatment is for 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samia Rashed
Phone
01226190094
Email
dr.samia_samir@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahima okeel
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amal Yousef
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled Kamel
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
ZIP/Postal Code
12662
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samia Rashed
Email
dr.samia_samir@yahoo.com

12. IPD Sharing Statement

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Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women

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