A home-based exercise intervention for individuals with high blood pressure in the lungs known as pulmonary hypertensio

Not Applicable

Completed

• Conditions: Pulmonary hypertension; Circulatory System

• Registration Number: ISRCTN83783446
• Lead Sponsor: Mater Misericordiae University Hospital

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33972341/ (added 12/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-23
• Study Completion: 2021-06-01
• Last Update Posted: 7 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age >18 years
2. PH diagnosed by right heart catheter showing baseline mean pulmonary arterial pressure =25 mm Hg
3. Pulmonary vascular resistance =240 dyn·s/cm5
4. Pulmonary capillary wedge pressure =15 mmHg
5. Receiving optimised conventional PH therapy including intensified treatment with diuretics and, who have been stable for the previous 3 months
6. Except for diuretics, medical treatment should not be expected to change during the study period
7. Negative pregnancy test (ß-HCG) at the start of the trial and counselling on the need to avoid pregnancy during the study for women with child-bearing potential
8. Ablility to understand and willing to sign the Informed consent form

Exclusion Criteria

1. PH of any cause other than permitted in the entry criteria, (e.g., concomitantly to portal hypertension, complex congenital heart disease, reversed shunt and HIV infection)
2. Signs of right heart decompensation
3. Acute infection and pyrexia
4. Change in disease-targeted therapy within the last 2 months
5. Scheduled to receive an investigational drug during the course of the study
6. FEV1/FVC <0.5, total lung capacity <70% of the normal value
7. Active liver disease, porphyria
8. Elevations of serum transaminases >3 x upper limit of normal (ULN), bilirubin > 1.5 x ULN
9. Haemoglobin concentration <75% of the lower limit of normal
10. Systolic blood pressure <85 mmHg
11. Active myocarditis, unstable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, hypertrophic obstructive cardiomyopathy or highly impaired left ventricular function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 23/10/2020: <br><br>The feasibility, acceptability and utility of the program for PH patients assessed via semi-structured interviews, self-reported questionnaires (at 10 weeks, see secondary outcome measures for questionnaires), participant recruitment and retention (on-going during trial), intervention adherence (ongoing during trial), patient safety and researcher field notes (ongoing during trial).<br><br>_____<br><br>Previous primary outcome measure:<br><br>The feasibility, acceptability and utility of the program for PH patients assessed via semi-structured interviews, self-reported questionnaires (at 12 weeks, see secondary outcome measures for questionnaires), participant recruitment and retention (on-going during trial), intervention adherence (ongoing during trial), patient safety and researcher field notes (ongoing during trial).