- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07728578
Effect of Pilates Training Versus High Intensity Interval Training on Cardiorespiratory Fitness in Asthmatic Patients
July 22, 2026 updated by: Ghidaa Elmahdi Eldomiaty, Horus University
To compare the effect of Pilates Training Versus High Intensity Interval Training on Cardiorespiratory Fitness in Asthmatic Patients.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Asthma is a widespread chronic inflammatory disease affecting over 300 million people globally, leading to approximately 461,000 deaths annually.
Exercise, particularly Pilates and high-intensity interval training, is critical for improving cardiorespiratory fitness and can enhance the quality of life for asthma patients, who often face reduced physical fitness and comorbidities like depression.
Pilates improves respiratory control and strengthens respiratory muscles, while high-intensity interval training enhances aerobic and anaerobic capacities, reduces inflammation, and improves maximal oxygen uptake (VO₂ max).
This study aims to establish guidelines comparing the effects of Pilates and high-intensity interval training on cardiorespiratory fitness in asthmatic patients.
Study Type
Interventional
Enrollment (Estimated)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ghidaa Elmahdi Eldomiaty, Assistant lecturer
- Phone Number: +20 10 22143737
- Email: gelmahdi@horus.edu.eg
Study Locations
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Damietta, Egypt
- out-patient clinic, faculty of physical therapy, Horus university
-
Contact:
- Ghidaa Elmahdi Eldomiaty, Assistant lecturer
- Phone Number: +20 10 22143737
- Email: gelmahdi@horus.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 51 patients diagnosed with a clinical diagnosis of asthma and a history of respiratory illness, aged between 30 and 40 years.
- Medically stable and capable of performing physical exercise.
- All participants provided written informed consent before enrollment.
- body mass index 25.0 - 29.9 (overweight)
- Patients with partially controlled asthma according to the Asthma Control Questionnaire (ACQ) from 0 to 1.5.
Exclusion Criteria:
- Participants with musculoskeletal limitations, cardiovascular instability, or any contraindications to exercise were excluded.
- Uncontrolled hypertension.
- Cognitive impaired patients.
- Severe Anemic patients.
- Pregnancy.
- Recent cardiothoracic surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates exercises
Patients will receive Pilates exercises administered to Group A include five movements: The Hundred, Single Leg Stretch, Side Kick, Toe Taps, and Leg Pull Front all performed with structured breathing patterns to emphasize respiratory control and core stabilization.
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17 Patients will perform Pilates exercises 40-60 mins, three times per week, over 8weeks. Pilates exercises include five movements: The Hundred, Single Leg Stretch, Side Kick, Toe Taps, and Leg Pull Front, all performed with structured breathing Patterns To Emphasize Respiratory Control And Core Stabilization
Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
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|
Experimental: low-volume high-intensity interval training
Patients will receive low-volume high-intensity interval training.
Participants will perform 3-minute High Intensity Interval Training intervals on a treadmill at 85- 90% of heart rate reserve, each followed by 2 minutes of moderate-intensity active recovery at 60% -70% of eart rate reserve.
The total time spent in the exercise session is 25-30 minutes.
|
Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
17 patients will engage in low-volume high-intensity interval training complemented by diaphragmatic breathing exercises.
Each session begins with a 5-10 minute warm-up on a treadmill at 40% of heart rate reserve.
The targeted heart rate during high-intensity interval training is set at 85-90% of heart rate reserve plus resting heart rate.
Participants will complete 3-minute high-intensity interval training intervals at the specified intensity, alternating with 2 minutes of moderate-intensity recovery at 60-70% heart rate reserve.
Total exercise duration is 25-30 minutes, concluding with a 5-minute cool-down at 30% heart rate reserve.
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Active Comparator: Diaphragmatic breathing exercises
Diaphragmatic breathing exercises involve inhaling slowly through the nose while keeping the chest still and allowing the diaphragm to move the stomach.
This is performed in a supine position, with one hand on the chest and the other on the belly, ensuring minimal chest movement.
Practitioners typically inhale and exhale over six seconds each.
|
Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of maximum oxygen consumption
Time Frame: At baseline and after 8 weeks
|
Cardiopulmonary exercise testing is essential for evaluating patient symptoms, disease severity, prognosis, and therapy responses.
It assesses the interaction of cardiovascular and pulmonary systems with other bodily systems.
maximum oxygen consumption is calculated using the Bruce protocol via the Ergo Spiro Device.
This protocol involves a multi-stage treadmill test, starting at a 10% grade and increasing speed and grade every three minutes until exhaustion.
Subjects must refrain from eating, smoking, and consuming caffeine before testing, and avoid intense exercise leading up to the test.
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At baseline and after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of Quality of Life
Time Frame: At baseline and after 8 weeks
|
The Mini-Asthma Quality of Life Questionnaire is a shortened, 15-item version of the original questionnaire, designed to accurately assess the quality of life in asthmatic patients without consuming much time.
It evaluates four domains: symptoms, activity limitation, emotional function, and environmental stimuli, based on the respondents' experiences over the past two weeks.
it employs a 7-point Likert scale, where 7 indicates no impairment and 1 signifies significant impairment
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At baseline and after 8 weeks
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assessment of dyspnea
Time Frame: At baseline and after 8 weeks
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The Modified Borg Dyspnea Scale is a validated, numerical rating scale used to quantify the subjective perception of breathlessness during physical activity or exercise.
The scale ranges from 0 to 10, where 0 indicates no breathlessness and 10 represents maximal or extremely severe breathlessness.
Participants are instructed to rate their perceived level of dyspnea immediately after or during exercise, providing a simple, reliable, and clinically applicable measure of symptom intensity for monitoring exercise tolerance and evaluating treatment outcomes.
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At baseline and after 8 weeks
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assessment of asthma symptoms
Time Frame: At baseline and after 8 weeks
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Asthma Control Questionnaire (ACQ-6) is a six-item questionnaire designed to measure asthma symptoms.
The questionnaire is scored by the mean of all items (0-6), with higher scores indicating poorer control.
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At baseline and after 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 25, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
July 22, 2026
First Submitted That Met QC Criteria
July 22, 2026
First Posted (Actual)
July 27, 2026
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ghidaa-PHD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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