Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

Not Applicable

Not yet recruiting

• Conditions: Rheumatic Arthritis; Lung Function

• Registration Number: NCT06716008
• Lead Sponsor: Middle East University

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).

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Status Verified: 2024-12
• Study Start: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-03-10
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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).
• Smokers.
• Joint surgery (in the preceding 6 months).
• Musculoskeletal/ neurological limitations to exercise.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilatory function	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 Outcome Measures

Name	Time	Method
Functional capacity	At baseline and after 12 weeks	Cardiopulmonary exercise test will be conducted for all women at baseline and post-study based on the guidelines set by the American College of Sports Medicine to determine maximal oxygen consumption for each women.