NCT06057701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

September 17, 2023

Last Update Submit

January 7, 2024

Conditions

Keywords

postmenopausal kyphosisflexicurve rulerdiaphragmatic excursioncorrective exercisesresisted diaphragmatic breathing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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)

    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.

    period of treatment is for 12 weeks

Study Arms (2)

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

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.

Other: corrective exercisesOther: resisted diaphragmatic breathing exercises

Interventions

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

control groupinterventional group

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

interventional group

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

Study Officials

  • Fahima okeel

    Cairo University

    STUDY CHAIR
  • Amal Yousef

    Cairo University

    STUDY DIRECTOR
  • Khaled Kamel

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 28, 2023

Study Start

September 30, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

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