- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07648524
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension: A Comparative Experimental Study
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rana Essam El Din Abd Elbar, Assistant lecturer
- Phone Number: 01013981766
- Email: rana.essam@acu.edu.eg
Study Locations
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Giza, Egypt
- Faculty of Physical Therapy ,Cairo University
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Contact:
- Rana Essam El Din Abd Elbar, Assistant lecturer
- Phone Number: 01013981766
- Email: rana.essam@acu.edu.eg
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Contact:
- Rana Essam El Din Abd Elbar, assistant lect P.T
- Email: rana.essam@acu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: group III PH with obstructive lung disease
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.
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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 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).
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Experimental: group III PHT with restrictive lung disease
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.
|
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 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).
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Experimental: control group III PH with obstructive lung disease
Group (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only
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medication
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Experimental: control group III PHT with restrictive lung disease
Group (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only
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medication
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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6-minute walk distance
Time Frame: 12 weeks
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total distance walked in 6 minutes
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12 weeks
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Maximal Oxygen Consumption
Time Frame: 12weeks
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Estimated VO2max
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12weeks
|
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spirometry
Time Frame: 12weeks
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FEV1, FVC, FEV1/FVC, MVV
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12weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dyspnea Severity
Time Frame: 12weeks
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Modified Borg Scale
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12weeks
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change Pulmonary Artery Pressure
Time Frame: 12weeks
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pulmonary artery pressure estimated by ECHO
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12weeks
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change of total score of SF-12 Questionnaire) Quality of Life
Time Frame: 12weeks
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more increase scores more increase quality of life
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12weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, faculty of P.T. Cairo University
- Study Chair: HEBA AHMED ALI ABDEEN, Prof, faculty of P.T. Cairo University
- Study Chair: HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, faculty of P.T. Cairo University
- Study Chair: REEM IBRAHIM EL KORASHY, prof of pulmonology, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/005518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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