Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

Effect of 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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Function; Rheumatic Arthritis
• Intervention / Treatment: Other: Aerobic training; Other: Manual Diaphragm Release

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Elgayar, Ph.D; Phone Number: +201020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Sayed Saif, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training only.	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.
Active Comparator: Manual diaphragmatic release group; 30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release	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 head and slightly laterally, accompanying the elevation of the ribs. Therapist progressively increases the depth of their contact within the costal margin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	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.	At baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Middle East University
• Investigators: Study Director: Mohammed Sayed Saif, Ph.D, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Estimated): December 3, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Arthritis; Rheumatic Fever
• Other Study ID Numbers: Manual Diaphragmatic Release

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No