Rheumatic ArthritisNCT06716008
Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis
A study testing Aerobic training and Manual Diaphragm Release in people with Rheumatic Arthritis and Lung Function, run by Middle East University.
Trial summary
Evaluate the effect of manual diaphragmatic release on ventilatory functions in women with rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Rheumatic Arthritis, Lung Function
- What is being tested?
- Aerobic training and Manual Diaphragm Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Sayed Saif, Ph.D contact
About this study
Official title: 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
Read the 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:
- 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).
- Conditions
- Rheumatic Arthritis, Lung Function
- Being tested
- Aerobic training, Manual Diaphragm Release
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
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 ReleaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual diaphragmatic release group | Active comparator | 30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release Receives: 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. Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 12 weeks
Secondary outcomes (1)
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.
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start3 Dec 2024 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Kasr El Aini Hospital
- Investigators
- Mohammed Sayed Saif, Ph.D, Study director, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716008
- Sponsor's protocol ID
- Manual Diaphragmatic Release
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41915908
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06716008
- Acronym / sponsor ID
- Manual Diaphragmatic Release
- Conditions
- Rheumatic Arthritis, Lung Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual diaphragmatic release group | Active comparator | Other: Aerobic training, Other: Manual Diaphragm Release30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release |
| Control group | Active comparator | Other: Aerobic training30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training only. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingFor 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 | Control group, Manual diaphragmatic release group |
| Manual Diaphragm ReleaseThe 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. | Other | Manual diaphragmatic release group |
Primary outcome
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.
1 secondary outcome
Functional capacity
Time frame: At baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 41915908Elgayar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Sayed Saif, Ph.D contact
Mohammed Sayed Saif, Ph.D study director
National institute for Gerontology
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Manual Diaphragm Release in people with Rheumatic Arthritis and Lung Function, run by Middle East University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Elgayar, Ph.D (+201020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory function (time frame: At baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.