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NCT Number: NCT06716008

Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatic Arthritis Arthritis Bacterial Infections Bacterial Infections and Mycoses Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Joint Diseases Lung Function Musculoskeletal Diseases Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Ventilatory functions (Forced vital capacity and total lung capacity).
  • Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
  • Quality of life (Short form health survey).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Functional capacity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Sayed Saif, Ph.D

CONTACT

Saher Elgayar, Ph.D

CONTACT

[email protected]

+201020429911

Sponsors and collaborators

Lead sponsor

Middle East University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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