Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis
NCT ID: NCT06716008
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-03
2025-04-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Manual diaphragmatic release group
30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training plus manual diaphragmatic release
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.
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.
Control group
30 women with rheumatoid arthritis who will receive low to moderate intensity aerobic training only.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
60 Years
FEMALE
No
Sponsors
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Middle East University
OTHER
Responsible Party
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Saher Lotfy El Gayar
Assistant Professor of Physical Therapy
Principal Investigators
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Mohammed Sayed Saif, Ph.D
Role: STUDY_DIRECTOR
National institute for Gerontology
Central Contacts
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Mohammed Sayed Saif, Ph.D
Role: CONTACT
Other Identifiers
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Manual Diaphragmatic Release
Identifier Type: -
Identifier Source: org_study_id