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Clinical Trials/NCT06716008
NCT06716008
Not yet recruiting
Not Applicable

Effect of Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

Middle East University0 sites60 target enrollmentDecember 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatic Arthritis
Sponsor
Middle East University
Enrollment
60
Primary Endpoint
Ventilatory function
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Evaluate the effect of manual diaphragmatic release on ventilatory functions in women with rheumatoid arthritis

Detailed Description

Sixty women with rheumatoid arthritis will be sourced from the rheumatology outpatient clinic at Tanta University hospitals in Egypt, with referrals from rheumatologists. Patients will be randomly assigned into two groups. The study group will include 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks while the control group will include 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes will be assessed: 1. Ventilatory functions (Forced vital capacity and total lung capacity). 2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation). 3. Quality of life (Short form health survey).

Registry
clinicaltrials.gov
Start Date
December 3, 2024
End Date
April 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Middle East University
Responsible Party
Principal Investigator
Principal Investigator

Saher Lotfy El Gayar

Assistant Professor of Physical Therapy

Kasr El Aini Hospital

Eligibility Criteria

Inclusion Criteria

  • All women will have rheumatoid arthritis for more than 2 years with low-to-moderate disease activity.
  • Normal to mildly restrictive lung pattern.
  • Their ages will be ranged from 40 to 60 years old.
  • Their body mass index will be less than 30 Kg/m2.

Exclusion Criteria

  • Chronic chest diseases.
  • Recent parenteral steroid administration.
  • Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
  • Joint surgery (in the preceding 6 months).
  • Musculoskeletal/ neurological limitations to exercise.
  • Pregnancy.

Outcomes

Primary Outcomes

Ventilatory function

Time Frame: At baseline and 12 weeks

Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second will be measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.

Secondary Outcomes

  • Functional capacity(At baseline and after 12 weeks)

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