Pulmonary Hypertension Due to Lung Disease (Disorder)NCT07648524
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension
A study testing cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Inspiratory Muscle Training and Medical treatment in people with Pulmonary Hypertension Due to Lung Disease (Disorder), run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of cardiopulmonary rehabilitation on cardiorespiratory parameters and functional capacity in patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Pulmonary Hypertension Due to Lung Disease (Disorder)
- What is being tested?
- cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Inspiratory Muscle Training and Medical treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jun 2026to 13 Sep 2026
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a)Medically stable pulmonary hypertension patients who were under optimized medical therapy. b)Pulmonary artery pressure ≥ 25 mmHg confirmed by RT side heart catheterization.
- c)Forty two male patients with group 3 pulmonary hypertension (Chest cause) include Obstructive lung disease ( COPD and sleep apnea ) and restrictive lung disease (ILD). d)The patients' ages will range from 45 to 65 years old. e)BMI (25 - 34.9) kg/m2. f)World Health Organization (WHO) classification of functional classes II to III ( class II are patients with pulmonary hypertension who have a mild limitation of physical activity )(class III are patients with pulmonary hypertension who have a marked limitation of physical activity
Who cannot join
- g)Uncontrolled systemic HTN. h)Other types of pulmonary hypertension.. i)Smoker j)Any condition of kidney failure. k)Neurological or musculoskeletal conditions that interfere with gait
- l)Impaired vision and/or hearing.
- m)Patients who are unable to follow verbal instructions. n)acute exacerbation condition. o)unstable angina, serious cardiac dysrhythmias on resting ECG.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy ,Cairo University
Giza
Rana Essam El Din Abd Elbar, Assistant lecturer, 01013981766, rana.essam@acu.edu.eg
Rana Essam El Din Abd Elbar, assistant lect P.T, rana.essam@acu.edu.eg
About this study
Official title: Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension: A Comparative Experimental Study
This study aims to investigate the effect of cardiopulmonary rehabilitation on cardiorespiratory parameters and functional capacity in patients with pulmonary hypertension.
Read the detailed description
Pulmonary hypertension is a progressive disease associated with reduced exercise capacity, respiratory muscle weakness, and impaired quality of life. Exercise training and respiratory muscle training have been shown to improve physical performance and quality of life in patients with pulmonary hypertension.
forty-two medically stable patients with Group III pulmonary hypertension due to lung diseases (obstructive and restrictive) will participate in this comparative experimental study. Participants will receive cardiopulmonary rehabilitation consisting of moderate-intensity interval aerobic training and inspiratory muscle training in addition to routine medical treatment. Outcome measures will include echocardiographic parameters, pulmonary function, six-minute walk distance, estimated VO2max, dyspnea severity, and quality of life. The study aims to evaluate the influence of cardiopulmonary rehabilitation on cardiorespiratory adaptation in patients with pulmonary hypertension.
- Being tested
- cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Inspiratory Muscle Training, Medical treatment
- Keywords
- Pulmonary Hypertension Cardiopulmonary Rehabilitation Inspiratory Muscle Training Exercise Training Functional Capacity Pulmonary Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic trainingBehavioural
Training will be conducted on a treadmill three times weekly for 12 weeks. Exercise intensity will progress from 30-40% to 60-70% of target heart rate. Each session will last 30 minutes and include warm-up and cool-down periods.
Inspiratory Muscle TrainingDevice
inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics). Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).
Medical treatmentOther
medication
| Study group | Role | What they receive |
|---|---|---|
| group III PH with obstructive lung disease | Experimental | Group (A), (n =16) patients with group III PH with obstructive lung disease will receive cardiopulmonary Rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment. Receives: Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training; Device: Inspiratory Muscle Training |
| group III PHT with restrictive lung disease | Experimental | group (B), (n =16) patients with group III PHT with restrictive lung disease will receive cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment. Receives: Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training; Device: Inspiratory Muscle Training |
| control group III PH with obstructive lung disease | Experimental | Group (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only Receives: Other: Medical treatment |
| control group III PHT with restrictive lung disease | Experimental | Group (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
total distance walked in 6 minutes
Measured: 12 weeks
Maximal Oxygen Consumption
Estimated VO2max
Measured: 12weeks
spirometry
FEV1, FVC, FEV1/FVC, MVV
Measured: 12weeks
Secondary outcomes (3)
Dyspnea Severity
Modified Borg Scale
Measured: 12weeks
change Pulmonary Artery Pressure
pulmonary artery pressure estimated by ECHO
Measured: 12weeks
change of total score of SF-12 Questionnaire) Quality of Life
more increase scores more increase quality of life
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start13 Jun 2026 (estimated)
- Primary completion13 Sep 2026 (estimated)
- Study completion13 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to Lung Disease (Disorder)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Essam Eldin Abd Elbar, Cairo University
- Investigators
- NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, Study chair, faculty of P.T. Cairo UniversityHEBA AHMED ALI ABDEEN, Prof, Study chair, faculty of P.T. Cairo UniversityHEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, Study chair, faculty of P.T. Cairo UniversityREEM IBRAHIM EL KORASHY, prof of pulmonology, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648524
- Sponsor's protocol ID
- P.T.REC/012/005518
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to protect participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension: A Comparative Experimental Study
- ClinicalTrials.gov ID
- NCT07648524
- Acronym / sponsor ID
- P.T.REC/012/005518
- Keywords
- Pulmonary Hypertension Cardiopulmonary Rehabilitation Inspiratory Muscle Training Exercise Training Functional Capacity Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jun 2026 (estimated)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 13 Sep 2026 (estimated)
- First posted
- 15 Jun 2026 (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.
This study aims to investigate the effect of cardiopulmonary rehabilitation on cardiorespiratory parameters and functional capacity in patients with pulmonary hypertension.
Detailed description
Pulmonary hypertension is a progressive disease associated with reduced exercise capacity, respiratory muscle weakness, and impaired quality of life. Exercise training and respiratory muscle training have been shown to improve physical performance and quality of life in patients with pulmonary hypertension.
forty-two medically stable patients with Group III pulmonary hypertension due to lung diseases (obstructive and restrictive) will participate in this comparative experimental study. Participants will receive cardiopulmonary rehabilitation consisting of moderate-intensity interval aerobic training and inspiratory muscle training in addition to routine medical treatment. Outcome measures will include echocardiographic parameters, pulmonary function, six-minute walk distance, estimated VO2max, dyspnea severity, and quality of life. The study aims to evaluate the influence of cardiopulmonary rehabilitation on cardiorespiratory adaptation in patients with pulmonary hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group III PH with obstructive lung disease | Experimental | Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Device: Inspiratory Muscle TrainingGroup (A), (n =16) patients with group III PH with obstructive lung disease will receive cardiopulmonary Rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment. |
| group III PHT with restrictive lung disease | Experimental | Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Device: Inspiratory Muscle Traininggroup (B), (n =16) patients with group III PHT with restrictive lung disease will receive cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment. |
| control group III PH with obstructive lung disease | Experimental | Other: Medical treatmentGroup (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only |
| control group III PHT with restrictive lung disease | Experimental | Other: Medical treatmentGroup (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a)Medically stable pulmonary hypertension patients who were under optimized medical therapy. b)Pulmonary artery pressure ≥ 25 mmHg confirmed by RT side heart catheterization.
- c)Forty two male patients with group 3 pulmonary hypertension (Chest cause) include Obstructive lung disease ( COPD and sleep apnea ) and restrictive lung disease (ILD). d)The patients' ages will range from 45 to 65 years old. e)BMI (25 - 34.9) kg/m2. f)World Health Organization (WHO) classification of functional classes II to III ( class II are patients with pulmonary hypertension who have a mild limitation of physical activity )(class III are patients with pulmonary hypertension who have a marked limitation of physical activity
Key exclusion criteria (3 listed)
- g)Uncontrolled systemic HTN. h)Other types of pulmonary hypertension.. i)Smoker j)Any condition of kidney failure. k)Neurological or musculoskeletal conditions that interfere with gait
- l)Impaired vision and/or hearing.
- m)Patients who are unable to follow verbal instructions. n)acute exacerbation condition. o)unstable angina, serious cardiac dysrhythmias on resting ECG.
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 |
|---|---|---|
| cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic trainingTraining will be conducted on a treadmill three times weekly for 12 weeks. Exercise intensity will progress from 30-40% to 60-70% of target heart rate. Each session will last 30 minutes and include warm-up and cool-down periods. | Behavioural | group III PH with obstructive lung disease, group III PHT with restrictive lung disease |
| Inspiratory Muscle Traininginspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics). Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale). | Device | group III PH with obstructive lung disease, group III PHT with restrictive lung disease |
| Medical treatmentmedication | Other | control group III PH with obstructive lung disease, control group III PHT with restrictive lung disease |
Primary outcome
6-minute walk distance
Time frame: 12 weeks
total distance walked in 6 minutes
Maximal Oxygen Consumption
Time frame: 12weeks
Estimated VO2max
spirometry
Time frame: 12weeks
FEV1, FVC, FEV1/FVC, MVV
3 secondary outcomes
Dyspnea Severity
Time frame: 12weeks
change Pulmonary Artery Pressure
Time frame: 12weeks
change of total score of SF-12 Questionnaire) Quality of Life
Time frame: 12weeks
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 15 Jun 2026.
- Individual participant dataSharing planned: No. to protect participant confidentiality
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RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
Recruiting
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RecruitingPhase 2
LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT study chair
faculty of P.T. Cairo University
HEBA AHMED ALI ABDEEN, Prof study chair
faculty of P.T. Cairo University
HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy study chair
faculty of P.T. Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training, Inspiratory Muscle Training and Medical treatment in people with Pulmonary Hypertension Due to Lung Disease (Disorder), run by Cairo University at 1 site in Egypt.
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 2 inclusion and 3 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Rana Essam El Din Abd Elbar, Assistant lecturer (01013981766, rana.essam@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.