Effect of Exercises on Diaphragmatic Excursion in Postmenopausal Kyphotic Women

January 7, 2024 updated by: Samia Samir Rashed, Cairo University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12662
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
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
Other: corrective exercises

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
Experimental: interventional group
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.
Other: corrective exercises

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
Other: resisted diaphragmatic breathing exercises
  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
period of treatment is for 12 weeks
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
period of treatment is for 12 weeks
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)
period of treatment is for 12 weeks
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.
period of treatment is for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Fahima okeel, Cairo University
  • Study Director: Amal Yousef, Cairo University
  • Principal Investigator: Khaled Kamel, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • postmenopausal kyphosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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