Clinical trial NCT06057701: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis Postural Thoracic
Keywords: postmenopausal kyphosis
flexicurve ruler
diaphragmatic excursion
corrective exercises
resisted diaphragmatic breathing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. All postmenopausal women suffering from thoracic kyphosis.
2. Their thoracic kyphosis (Cobb's) angles were more than 45 degrees.
3. Their age ranged from 50-60 years old.
4. Their BMI were \>25 and \<30 kg/m2.

Exclusion Criteria:

1. All patients with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
2. Patients with previous trauma to the spine, pelvis and lower limbs.
3. Patients with a previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or kyphoplasty).
4. Patients with congenital spinal deformities and scoliosis.
5. Patients with a history of spinal tumors, ankylosing spondylitis, osteoporosis and other spondyloarthritis.
6. The patients received medications that might affect the neuromuscular functions at least three months before or during the study course.
7. Patients suffered from mental or psychological disorders.
8. Patients suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.

Primary outcomes:
measure: flexicurve ruler
timeFrame: period of treatment is for 12 weeks
measure: Diaphragmatic excursion
timeFrame: period of treatment is for 12 weeks
measure: Quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-41)
timeFrame: period of treatment is for 12 weeks
measure: Pain assessment scale
timeFrame: period of treatment is for 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Fahima okeel
role: STUDY_CHAIR
affiliation: Cairo University
name: Amal Yousef
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Khaled Kamel
role: PRINCIPAL_INVESTIGATOR
References: