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Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06716008
Enrollment
60
Registered
2024-12-04
Start date
2024-12-03
Completion date
2025-04-01
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Function, Rheumatic Arthritis

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).

Interventions

OTHERAerobic training

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.

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.

Sponsors

Middle East University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventilatory functionAt baseline and 12 weeksVentilatory 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

MeasureTime frameDescription
Functional capacityAt baseline and after 12 weeksCardiopulmonary 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.

Contacts

Primary ContactSaher Elgayar, Ph.D
saherlotfy020@gmail.com+201020429911
Backup ContactMohammed Sayed Saif, Ph.D

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026