Pulmonary Arterial Hypertension Clinical Trial
Official title:
The Effect of Adding Exercise Training to Optimal Therapy in Pulmonary Arterial Hypertension
Verified date | August 2019 |
Source | National Health Service, United Kingdom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right
ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted
therapy, increases EC by improving SV. Additional factors may contribute to exercise
limitation:
- Peripheral and respiratory muscle dysfunction
- Autonomic dysfunction
- An altered profile of inflammation
- Mitochondrial dysfunction.
The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training
in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this
improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting
treatment goals, will be enrolled in a 30-week randomised exercise training program.
One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other
will receive standard care for 15 weeks then 15 weeks training.
Aims:
1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug
therapy a UK PAH population.
2. Explore mechanisms of exercise limitation and factors that improve with training,
assessing:
- Cardiac function
- Skeletal muscle function
- Autonomic function
- Respiratory muscle strength
- Serum and muscle profile of inflammation
Primary outcomes (15 weeks)
1. 6 minute walk distance
2. QOL
3. RV ejection fraction
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - World health organisation functional class (WHO-FC) II-III - Stable on optimal disease targeted therapy for = 3 months - 18 years of age or older Exclusion criteria - Unable to provide informed consent - Significant peripheral vascular disease, neurological or musculoskeletal comorbidity - Exercise induced syncope, cardiac arrhythmia or chest pain - Pregnancy - Specific component exclusions: Cardiac MRI (CMR): Any contraindication to MRI |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dr Martin Johnson | Glasgow City |
Lead Sponsor | Collaborator |
---|---|
National Health Service, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Profile of inflammatory cytokines | change in profile of pro-inflammatory serum cytokines as measured by multiplex ELISA from baseline to 15 weeks following exercise training. | 15 weeks | |
Other | Insulin resistance | Change in HOMA-IR score from baseline to 15 weeks following exercise therapy (scored from fasting serum c-peptide and glucose) | 15 weeks | |
Primary | 6 minute walk distance | Change in distance walked in 6 minutes from baseline following 15 weeks of exercise therapy | 15 weeks | |
Primary | Quality of life | Change in pulmonary hypertension specific (EMPHASIS and CAMPHOR) and generic (SF-36 v2) quality of life scores from baseline to 15 weeks following exercise therapy. | 15 weeks | |
Primary | Right Ventricular Ejection Fraction | Change in right ventricular ejection fraction from baseline to 15 weeks as measured by cardiac magnetic resonance imaging. | 15 weeks | |
Secondary | Peak oxygen uptake | Peak oxygen uptake as measured by standard incremental cardiopulmonary exercise testing (CPET) at 15 weeks in addition to all other standard CPET variables | 15 weeks | |
Secondary | Muscle strength and endurance | change in quadriceps strength and endurance, and hand grip endurance and strength from baseline to 15 weeks, as measured by a myometer | 15 weeks | |
Secondary | Transfer factor for lung carbon monoxide | Transfer factor for lung carbon monoxide as measured during standard pulmonary function testing. Change from baseline to 3 weeks. | 3 weeks | |
Secondary | Respiratory muscle strength | change maximum inspiratory and maximum expiratory pressure measured following 3 weeks of exercise therapy. | 3 weeks | |
Secondary | Pulmonary vascular resistance | Change from baseline to 15 weeks, of pulmonary vascular resistance and total pulmonary resistance as measured during resting and exercise right heart catheterisation | 15 weeks | |
Secondary | Cardiac Output at rest and peak exercise | Change in cardiac output from baseline to 15 weeks as measured by right heart catheterisation at rest and on supine exercise | 15 weeks | |
Secondary | Change in resting and peak exercise mixed venous oxygen saturation | Change in mixed venous oxygen saturation from baseline to week 15, as measured from the central pulmonary artery during resting and exercise right heart catheterisation. | 15 weeks | |
Secondary | Left ventricular ejection fraction | Left ventricular ejection fraction as measured by cardiac MRI - change from baseline to 15 weeks following exercise therapy | 15 weeks |
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