- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rana Essam El Din Abd Elbar, Assistant lecturer
- Telefoonnummer: 01013981766
- E-mail: rana.essam@acu.edu.eg
Studie Locaties
-
-
-
Giza, Egypte
- faculty of physical therapy ,Cairo University
-
Contact:
- Rana Essam El Din Abd Elbar, Assistant lecturer
- Telefoonnummer: 01013981766
- E-mail: rana.essam@acu.edu.eg
-
Contact:
- Rana Essam El Din Abd Elbar, assistant lect P.T
- E-mail: rana.essam@acu.edu.eg
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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).
|
|
Experimenteel: 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).
|
|
Experimenteel: 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
|
medication
|
|
Experimenteel: 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
|
medication
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
6-minute walk distance
Tijdsspanne: 12 weeks
|
total distance walked in 6 minutes
|
12 weeks
|
|
Maximal Oxygen Consumption
Tijdsspanne: 12weeks
|
Estimated VO2max
|
12weeks
|
|
spirometry
Tijdsspanne: 12weeks
|
FEV1, FVC, FEV1/FVC, MVV
|
12weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dyspnea Severity
Tijdsspanne: 12weeks
|
Modified Borg Scale
|
12weeks
|
|
change Pulmonary Artery Pressure
Tijdsspanne: 12weeks
|
pulmonary artery pressure estimated by ECHO
|
12weeks
|
|
change of total score of SF-12 Questionnaire) Quality of Life
Tijdsspanne: 12weeks
|
more increase scores more increase quality of life
|
12weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, faculty of P.T. Cairo University
- Studie stoel: HEBA AHMED ALI ABDEEN, Prof, faculty of P.T. Cairo University
- Studie stoel: HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, faculty of P.T. Cairo University
- Studie stoel: REEM IBRAHIM EL KORASHY, prof of pulmonology, Cairo University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- P.T.REC/012/005518
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .