Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

NCT06716008 | Not Yet Recruiting DMC

• 1 other identifier: Manual Diaphragmatic Release
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatic Arthritis; Lung Function

Outcome Measures

Primary Outcomes (1)

• Ventilatory function

  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.

  At baseline and 12 weeks

Secondary Outcomes (1)

• Functional capacity

  At baseline and after 12 weeks

Study Arms (2)

Manual diaphragmatic release group

ACTIVE COMPARATOR

30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release

Other: Aerobic training; Other: Manual Diaphragm Release

Control group

ACTIVE COMPARATOR

30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training only.

Other: Aerobic training

Interventions

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.

Control group; Manual diaphragmatic release group

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.

Manual diaphragmatic release group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Middle East University: lead

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohammed Sayed Saif, Ph.D

  National institute for Gerontology

  STUDY DIRECTOR

Central Study Contacts

Saher Elgayar, Ph.D

CONTACT

+201020429911; saherlotfy020@gmail.com

Mohammed Sayed Saif, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 3, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share