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NCT Number: NCT06057701

Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women

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.

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Key information

Conditions

Kyphosis Postural Thoracic

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Corrective exercises

Other

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 exercises

Other
  • 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 outcomes

  1. 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.

  2. 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

  3. 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)

  4. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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