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Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism

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ClinicalTrials.gov Identifier: NCT04241497
Recruitment Status : Unknown
Verified January 2020 by Marius Lebret, Laval University.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Marius Lebret, Laval University

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 28, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
Epigenetic factors influencing muscle metabolism [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
Transcriptome analysis using RNA-seq
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Intramyocellular lipid accumulation [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    H-magnetic resonance spectroscopy and Oil red O technique
  • Muscular mitochondrial phosphorylation (ATP synthesis) [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    phosphorus-31 Magnetic resonance spectroscopy saturation transfer
  • Proportion of muscle fiber types [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Ethanol modified technique
  • HbA1c [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum HbA1c
  • Insulin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Insulin
  • Glucose [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum glucose
  • Apolipoprotein A1 [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Apolipoprotein A1
  • Adiponectin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Adiponectin
  • Leptin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum leptin
  • Volitional strength quadriceps [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Maximal Voluntary force using isometric force meter
  • Non-volitional strength of the quadriceps [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Maximal non-Voluntary force using isometric force meter and magnetic stimulation of the femoral neve
  • Maximal exercise capacity [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Cardio-pulmonary exercise testing on a cycloergometer
  • Functional Exercise capacity [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    6-MWD
  • Quality of life (QOL) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Intramyocellular lipid accumulation [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    H-magnetic resonance spectroscopy and Oil red O technique
  • Muscular mitochondrial phosphorylation (ATP synthesis) [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    phosphorus-31 Magnetic resonance spectroscopy saturation transfer
  • Proportion of muscle fiber types [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Ethanol modified technique
  • HbA1c [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum HbA1c
  • Insulin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Insulin
  • Glucose [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum glucose
  • Apolipoprotein A1 [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Apolipoprotein A1
  • Adiponectin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum Adiponectin
  • Leptin [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Serum leptin
  • Volitional strength quadriceps [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Maximal Voluntary force using isometric force meter
  • Non-volitional strength of the quadriceps [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Maximal non-Voluntary force using isometric force meter and magnetic stimulation of the femoral neve
  • Maximal exercise capacity [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    Cardio-pulmonary exercise testing on a cycloergometer
  • Functional Exercise capacity [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    6-MWD
  • Quality of life (QOL) [ Time Frame: Changes between baseline and 12 weeks of exercise rehabilitation ]
    CAMPHOR questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
Official Title  ICMJE Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Exercise Training
  • Home-based Rehabilitation
  • Exercise Capacity
  • Muscle Metabolism
  • Muscle Function
  • Lipid Infiltration
  • Oxidative Metabolism
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Patients with Pulmonary Arterial Hypertension
12 weeks home-based rehabilitation
Intervention: Behavioral: Home-based rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241497
Other Study ID Numbers  ICMJE HTAP A DOM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Marius Lebret, Laval University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Laval University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Laval University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP