Pulmonary hypertension Circulatory System
Conditions
Interventions
Current interventions as of 02/02/2021:
Participants will undertake baseline tests, selective testing at 6 weeks, and post-intervention testing at 10 weeks. Following baseline testing, participants
Sponsors
Mater Misericordiae University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 23/10/2020: 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). _____ Previous primary outcome measure: 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/04/2023: 1. Exercise capacity assessed using 6MWT at baseline, 10 weeks and 20 weeks 2. Quality of Life using PH -specific questionnaire (CAMPHPOR) at 10 weeks and 20 weeks 3. Physical activity assessed using accelerometry (ActivPAL) at baseline, 10 weeks and 20 weeks 4. Fatigue assessed by The Fatigue Severity Scale (FSS) at baseline, 10 weeks and 20 weeks 5. Self-regulatory self-efficacy for exercise using modified 11-item scale at baseline, 10 weeks and 20 weeks 6. Outcome expectations assessed by 10-items at baseline, 10 weeks and 20 weeks 7. Intentions for exercise assessed using modified intentions for exercise scale at baseline, 10 weeks and 20 weeks 8. Social support assed using social support for exercise from family and friends scale at baseline, 10 weeks and 20 weeks 9. Lower body strength assessed by Sit-to-stand at baseline, 10 weeks and 20 weeks 10. WHO Functional class assessed at baseline, 10 weeks and 20 weeks _____ Previous secondary outcome measures as of 02/02/2021: 1. Exercise capacity assessed using 6MWT at baseline, 10 weeks and 20 weeks 2. Quality of Life using PH -specific questionnaire (CAMHPOR & Emphasis-10) and General SF-36 at baseline, 10 weeks and 20 weeks 3. Physical activity assessed using accelerometry (ActivPAL) at baseline, 10 weeks and 20 weeks 4. Fatigue assed by The Fatigue Severity Scale (FSS) at baseline, 10 weeks and 20 weeks 5. Self-regulatory self-efficacy for exercise using modified 11-item scale at baseline, 10 weeks and 20 weeks 6. Outcome expectations assessed by 10-items at baseline, 10 weeks and 20 weeks 7. Intentions for exercise assessed using modified intentions for exercise scale at baseline, 10 weeks and 20 weeks 8. Social support assed using social support for exercise from family and friends scale at baseline, 10 weeks and 20 weeks 9. Lower body strength assessed by Sit-to-stand at baseline, 10 weeks and 20 weeks 10. WHO Functional class assessed at baseline, 1 | — |
Countries
Ireland
Contacts
Public ContactCiara Mc Cormack
Outcome results
None listed