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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04241497
Other study ID # HTAP A DOM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2020
Est. completion date March 2021

Study information

Verified date January 2020
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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


Intervention

Behavioral:
Home-based rehabilitation
1 supervised exercise session at the hospital; 3 weeks of supervised home-based exercise training (3x/week); 9 weeks of unsupervised home-based exercise training (3x/week)

Locations

Country Name City State
Canada University Institute of Cardiology and Respirology of Quebec Québec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Ehlken N, Lichtblau M, Klose H, Weidenhammer J, Fischer C, Nechwatal R, Uiker S, Halank M, Olsson K, Seeger W, Gall H, Rosenkranz S, Wilkens H, Mertens D, Seyfarth HJ, Opitz C, Ulrich S, Egenlauf B, Grünig E. Exercise training improves peak oxygen consump — View Citation

Grünig E, Eichstaedt C, Barberà JA, Benjamin N, Blanco I, Bossone E, Cittadini A, Coghlan G, Corris P, D'Alto M, D'Andrea A, Delcroix M, de Man F, Gaine S, Ghio S, Gibbs S, Gumbiene L, Howard LS, Johnson M, Jureviciene E, Kiely DG, Kovacs G, MacKenzie A, — View Citation

Grünig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training — View Citation

Malenfant S, Brassard P, Paquette M, Le Blanc O, Chouinard A, Nadeau V, Allan PD, Tzeng YC, Simard S, Bonnet S, Provencher S. Compromised Cerebrovascular Regulation and Cerebral Oxygenation in Pulmonary Arterial Hypertension. J Am Heart Assoc. 2017 Oct 12 — View Citation

Malenfant S, Potus F, Fournier F, Breuils-Bonnet S, Pflieger A, Bourassa S, Tremblay È, Nehmé B, Droit A, Bonnet S, Provencher S. Skeletal muscle proteomic signature and metabolic impairment in pulmonary hypertension. J Mol Med (Berl). 2015 May;93(5):573- — View Citation

Potus F, Malenfant S, Graydon C, Mainguy V, Tremblay È, Breuils-Bonnet S, Ribeiro F, Porlier A, Maltais F, Bonnet S, Provencher S. Impaired angiogenesis and peripheral muscle microcirculation loss contribute to exercise intolerance in pulmonary arterial h — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Epigenetic factors influencing muscle metabolism Transcriptome analysis using RNA-seq Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Intramyocellular lipid accumulation H-magnetic resonance spectroscopy and Oil red O technique Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Muscular mitochondrial phosphorylation (ATP synthesis) phosphorus-31 Magnetic resonance spectroscopy saturation transfer Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Proportion of muscle fiber types Ethanol modified technique Changes between baseline and 12 weeks of exercise rehabilitation
Secondary HbA1c Serum HbA1c Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Insulin Serum Insulin Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Glucose Serum glucose Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Apolipoprotein A1 Serum Apolipoprotein A1 Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Adiponectin Serum Adiponectin Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Leptin Serum leptin Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Volitional strength quadriceps Maximal Voluntary force using isometric force meter Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Non-volitional strength of the quadriceps Maximal non-Voluntary force using isometric force meter and magnetic stimulation of the femoral neve Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Maximal exercise capacity Cardio-pulmonary exercise testing on a cycloergometer Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Functional Exercise capacity 6-MWD Changes between baseline and 12 weeks of exercise rehabilitation
Secondary Quality of life (QOL) 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 Changes between baseline and 12 weeks of exercise rehabilitation
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