Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

NCT06716008 — Not applicable, Not yet recruiting, 60 participants, Middle East University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06716008
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment60 (Estimated)
SponsorMiddle East University (Other)
ConditionsRheumatic Arthritis, Lung Function
InterventionsAerobic training, Manual Diaphragm Release (Other)
Datesstart 2024-12-03 (estimated), primary completion 2025-03-10 (estimated), completion 2025-04-01 (estimated), first posted 2024-12-04, last updated 2024-12-09

Related Papers Related Patents Related Grants Related Experts
All trials for Rheumatic Arthritis All trials for Lung Function All trials of Aerobic training All trials of Manual Diaphragm Release

-Summary

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

Expand all sections  ·  Collapse all

+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).

+Arms and interventions

ArmTypeInterventionsDescription
Manual diaphragmatic release groupActive comparatorOther: Aerobic training; Other: Manual Diaphragm Release30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release
Control groupActive comparatorOther: Aerobic training30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training only.
  • Aerobic training (Other): For twelve weeks, the women in the study group will participate in aerobic training on cycle ergometer. Each session will consist of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session will end with a brief 3-minute period of cool-down.
  • Manual Diaphragm Release (Other): The participant will assume a supine position with relaxed limbs. The therapist should position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. The therapist's forearms should be aligned towards the participant's shoulders. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. Therapist progressively increases the depth of their contact within the costal margin.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: Female, ages: 40 Years to 60 Years

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.

+Publications

  • Results publication: Elgayar SL, Bayoumi MBI. Effect of manual diaphragmatic release on ventilatory function and quality of life in women with rheumatoid arthritis: a randomized controlled trial. J Man Manip Ther. 2026 Mar 31:1-9. doi: 10.1080/10669817.2026.2651381. Online ahead of print. PMID 41915908

+Investigators