Kyphosis Postural ThoracicNCT06057701
Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women
A study testing corrective exercises and resisted diaphragmatic breathing exercises in people with Kyphosis Postural Thoracic, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kyphosis Postural Thoracic
- What is being tested?
- corrective exercises and resisted diaphragmatic breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kyphosis Postural Thoracic
- Being tested
- corrective exercises, resisted diaphragmatic breathing exercises
- Keywords
- postmenopausal kyphosis, flexicurve ruler, diaphragmatic excursion, corrective exercises, resisted diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corrective exercisesOther
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
resisted diaphragmatic breathing exercisesOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | 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 Receives: Other: corrective exercises |
| interventional group | Experimental | 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. Receives: Other: corrective exercises; Other: resisted diaphragmatic breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: period of treatment is for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start30 Sep 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kyphosis Postural ThoracicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Samir Rashed, Cairo University
- Investigators
- Fahima okeel, Study chair, Cairo UniversityAmal Yousef, Study director, Cairo UniversityKhaled Kamel, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057701
- Sponsor's protocol ID
- postmenopausal kyphosis
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women
- ClinicalTrials.gov ID
- NCT06057701
- Acronym / sponsor ID
- postmenopausal kyphosis
- Conditions
- Kyphosis Postural Thoracic
- Keywords
- postmenopausal kyphosis, flexicurve ruler, diaphragmatic excursion, corrective exercises, resisted diaphragmatic breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: corrective exercisesThis 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 | Experimental | Other: corrective exercises, Other: resisted diaphragmatic breathing exercisesThis 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corrective exercisescorrective 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 | Other | control group, interventional group |
| resisted diaphragmatic breathing exercises1. 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 | Other | interventional group |
Primary outcome
flexicurve ruler
Time frame: period of treatment is for 12 weeks
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
Time frame: period of treatment is for 12 weeks
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)
Time frame: period of treatment is for 12 weeks
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
Time frame: period of treatment is for 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahima okeel study chair
Cairo University
Amal Yousef study director
Cairo University
Khaled Kamel principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corrective exercises and resisted diaphragmatic breathing exercises in people with Kyphosis Postural Thoracic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flexicurve ruler (time frame: period of treatment is for 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.