Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
- Conditions
- Lipid InfiltrationPulmonary Arterial HypertensionMuscle MetabolismMuscle FunctionExercise TrainingOxidative MetabolismHome-based RehabilitationExercise Capacity
- Interventions
- Behavioral: Home-based rehabilitation
- Registration Number
- NCT04241497
- Lead Sponsor
- Laval University
- Brief Summary
Pulmonary Arterial Hypertension has gone from a disease that causes rapid death to a more chronic condition. Yet, improved survival is associated with major challenges for clinicians as most patients remain with poor quality of life and limited exercise capacity. The effects of exercise training on exercise capacity have been largely evaluated and showed an improvement in 6-minutes walking distance (6MWD), peak V'O2. It is also known that exercise program improves quality of life. Maximal volitional and nonvolitional strength of the quadriceps are reduced in patients with Pulmonary Arterial Hypertension and correlated to exercise capacity. Moreover, on the cellular level, alterations are observed in both the respiratory as well as the peripheral muscles. Muscle fiber size has been reported to be decreased in some studies or conversely unaltered in human and animal models. Reduction in type I fibers and a more anaerobic energy metabolism has also been reported, but not in all studies. Likewise, a loss in capillary density in quadriceps of patients with Pulmonary Arterial Hypertension and rats has been reported, but could not be confirmed in other studies. While the impact of exercise training on clinical outcomes such as exercise capacity or quality of life is well known, this data highlight the fact that the underlying causes of peripheral muscle weakness as well as the mechanisms underlying the clinical improvements observed with exercise programs are not completely understood. Improvement of muscle cell metabolism in part via the enhancement of oxidative cellular metabolism and decrease in intracellular lipid accumulation may play a role in improving muscle function and exercise capacity.
In this study, we intend to evaluate the impact of a 12 weeks home-based rehabilitation program on peripheral muscle function and metabolism, focusing on lipid infiltration, oxidative metabolism and epigenetic factors that can be involved in metabolic syndrome, in patients with Pulmonary Arterial Hypertension.
- Detailed Description
The 12 weeks home-based rehabilitation program is detailed as follows:
* 1st sessions at the hospital, in the presence of a physiotherapist/kinesiologist
* 3 weeks of supervised home-based rehabilitation (using a telemonitoring system) 3 times a weeks
* 9 weeks of unsupervised home-based rehabilitation (one phone call a week)
Patients will be evaluated at baseline and at endpoint (12 weeks)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- Men or women > 18 years old
- Pulmonary Arterial Hypertension group 1: idiopathic, genetics, drug or toxin-induced, associated with connective tissue, HIV, portal hypertension, congenital heart disease.
- Diagnosis performed by right heart catheterization with Pulmonary Arterial Pressure⩾ 20 mmHg, pulmonary artery occlusion pressure <15 and pulmonary vascular resistance >3 Wood units
- New York Heart Association II or III and a 6-Minute Walk Test < 500m
- Patient stable without therapeutic modification within the last 3 months
- Patient having wireless internet at home
- Consciously informed and written by the patient
- Syncope within the last 6 month
- Metabolic comorbidity (eg Diabetes)
- Musculoskeletal impairment that does not allow physical exercise
- Patient unable or with contraindications to perform a cardio pulmonary exercise testing
- Patient with pulmonary veno-occlusive disease
- Presence of a permanent pacemaker or other contraindication to MRI
- Pregnant or breastfeeding woman
- Age <18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Pulmonary Arterial Hypertension Home-based rehabilitation 12 weeks home-based rehabilitation
- Primary Outcome Measures
Name Time Method Epigenetic factors influencing muscle metabolism Changes between baseline and 12 weeks of exercise rehabilitation Transcriptome analysis using RNA-seq
- Secondary Outcome Measures
Name Time Method HbA1c Changes between baseline and 12 weeks of exercise rehabilitation Serum HbA1c
Intramyocellular lipid accumulation Changes between baseline and 12 weeks of exercise rehabilitation H-magnetic resonance spectroscopy and Oil red O technique
Proportion of muscle fiber types Changes between baseline and 12 weeks of exercise rehabilitation Ethanol modified technique
Muscular mitochondrial phosphorylation (ATP synthesis) Changes between baseline and 12 weeks of exercise rehabilitation phosphorus-31 Magnetic resonance spectroscopy saturation transfer
Insulin Changes between baseline and 12 weeks of exercise rehabilitation Serum Insulin
Glucose Changes between baseline and 12 weeks of exercise rehabilitation Serum glucose
Non-volitional strength of the quadriceps Changes between baseline and 12 weeks of exercise rehabilitation Maximal non-Voluntary force using isometric force meter and magnetic stimulation of the femoral neve
Apolipoprotein A1 Changes between baseline and 12 weeks of exercise rehabilitation Serum Apolipoprotein A1
Adiponectin Changes between baseline and 12 weeks of exercise rehabilitation Serum Adiponectin
Volitional strength quadriceps Changes between baseline and 12 weeks of exercise rehabilitation Maximal Voluntary force using isometric force meter
Functional Exercise capacity Changes between baseline and 12 weeks of exercise rehabilitation 6-MWD
Leptin Changes between baseline and 12 weeks of exercise rehabilitation Serum leptin
Maximal exercise capacity Changes between baseline and 12 weeks of exercise rehabilitation Cardio-pulmonary exercise testing on a cycloergometer
Quality of life (QOL) Changes between baseline and 12 weeks of exercise rehabilitation Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire. The CAMPHOR questionnaire contains 65 items in total, 25 relating to symptoms, 15 relating to activities, and 25 relating to QoL. It is negatively weighted; a higher score indicates worse QoL and greater functional limitation. Symptom and QoL items are both scored out of 25: "yes/true" scores 1 and "no/not true" scores 0. Activity items have three possible responses (score 0-2), giving a score out of 30. Each CAMPHOR assessment takes an average of 10 min
Trial Locations
- Locations (1)
University Institute of Cardiology and Respirology of Quebec
🇨🇦Québec, Canada