- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Rana Essam El Din Abd Elbar, Assistant lecturer
- Numero di telefono: 01013981766
- Email: rana.essam@acu.edu.eg
Luoghi di studio
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Giza, Egitto
- Faculty of Physical Therapy ,Cairo University
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Contatto:
- Rana Essam El Din Abd Elbar, Assistant lecturer
- Numero di telefono: 01013981766
- Email: rana.essam@acu.edu.eg
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Contatto:
- Rana Essam El Din Abd Elbar, assistant lect P.T
- Email: rana.essam@acu.edu.eg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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6-minute walk distance
Lasso di tempo: 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
Lasso di tempo: 12weeks
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Estimated VO2max
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12weeks
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spirometry
Lasso di tempo: 12weeks
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FEV1, FVC, FEV1/FVC, MVV
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12weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dyspnea Severity
Lasso di tempo: 12weeks
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Modified Borg Scale
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12weeks
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change Pulmonary Artery Pressure
Lasso di tempo: 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
Lasso di tempo: 12weeks
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more increase scores more increase quality of life
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12weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, faculty of P.T. Cairo University
- Cattedra di studio: HEBA AHMED ALI ABDEEN, Prof, faculty of P.T. Cairo University
- Cattedra di studio: HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, faculty of P.T. Cairo University
- Cattedra di studio: REEM IBRAHIM EL KORASHY, prof of pulmonology, Cairo University
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- P.T.REC/012/005518
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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