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Not yet recruiting NCT06716008

Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

No phase Interventional Rheumatic Arthritis Lung Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic training, Manual Diaphragm Release.
Who it may be relevant to
Registry conditions: Rheumatic Arthritis, Lung Function. Basic parameters: 40 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Aerobic 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.
  • Other Manual Diaphragm Release
    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 hea

Primary outcome measures

  • Ventilatory function [Time frame: At baseline and 12 weeks]
Secondary outcome measures (1)
  • Functional capacity [Time frame: At baseline and after 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06716008 · Manual Diaphragmatic Release

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗