Pulmonary Arterial HypertensionNCT04241497
Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
A study testing Home-based rehabilitation in people with Pulmonary Arterial Hypertension and Exercise Training, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Exercise Training, Home-based Rehabilitation
- What is being tested?
- Home-based rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Institute of Cardiology and Respirology of Quebec
Québec, QC G1V 4G5
Marius Lebret, PhD, 418 656 8711 ext. 2560, marius.lebret@criucpq.ulaval.ca
Steeve Provencher, MD, 418 656 8711 ext. 5526, steeve.provencher@criucpq.ulaval.ca
About this study
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.
Read the 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)
- Conditions
- Pulmonary Arterial Hypertension, Exercise Training, Home-based Rehabilitation, Exercise Capacity, Muscle Metabolism, Muscle Function
- Being tested
- Home-based rehabilitation
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Patients with Pulmonary Arterial Hypertension | Experimental | 12 weeks home-based rehabilitation Receives: Behavioral: Home-based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic factors influencing muscle metabolism
Transcriptome analysis using RNA-seq
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Secondary outcomes (14)
Intramyocellular lipid accumulation
H-magnetic resonance spectroscopy and Oil red O technique
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Muscular mitochondrial phosphorylation (ATP synthesis)
phosphorus-31 Magnetic resonance spectroscopy saturation transfer
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Proportion of muscle fiber types
Ethanol modified technique
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
HbA1c
Serum HbA1c
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Insulin
Serum Insulin
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Glucose
Serum glucose
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Apolipoprotein A1
Serum Apolipoprotein A1
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Adiponectin
Serum Adiponectin
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Leptin
Serum leptin
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Volitional strength quadriceps
Maximal Voluntary force using isometric force meter
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Non-volitional strength of the quadriceps
Maximal non-Voluntary force using isometric force meter and magnetic stimulation of the femoral neve
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Maximal exercise capacity
Cardio-pulmonary exercise testing on a cycloergometer
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Functional Exercise capacity
6-MWD
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
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
Measured: Changes between baseline and 12 weeks of exercise rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Lebret, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241497
- Sponsor's protocol ID
- HTAP A DOM
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grunig 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 in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
PubMed 22323570Ehlken 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, Grunig E. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016 Jan 1;37(1):35-44. doi: 10.1093/eurheartj/ehv337. Epub 2015 Jul 31.
PubMed 26231884Grunig E, Eichstaedt C, Barbera 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, Marra AM, McCaffrey N, McCaughey P, Naeije R, Olschewski H, Pepke-Zaba J, Reis A, Santos M, Saxer S, Tulloh RM, Ulrich S, Vonk Noordegraaf A, Peacock AJ. ERS statement on exercise training and rehabilitation in patients with severe chronic pulmonary hypertension. Eur Respir J. 2019 Feb 28;53(2):1800332. doi: 10.1183/13993003.00332-2018. Print 2019 Feb.
PubMed 30578391Potus F, Malenfant S, Graydon C, Mainguy V, Tremblay E, 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 hypertension. Am J Respir Crit Care Med. 2014 Aug 1;190(3):318-28. doi: 10.1164/rccm.201402-0383OC.
PubMed 24977625Malenfant 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;6(10):e006126. doi: 10.1161/JAHA.117.006126.
PubMed 29025748Malenfant S, Potus F, Fournier F, Breuils-Bonnet S, Pflieger A, Bourassa S, Tremblay E, Nehme 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):573-84. doi: 10.1007/s00109-014-1244-0. Epub 2014 Dec 30.
PubMed 25548805
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism
- ClinicalTrials.gov ID
- NCT04241497
- Acronym / sponsor ID
- HTAP A DOM
- Conditions
- Pulmonary Arterial Hypertension, Exercise Training, Home-based Rehabilitation, Exercise Capacity, Muscle Metabolism, Muscle Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Pulmonary Arterial Hypertension | Experimental | Behavioral: Home-based rehabilitation12 weeks home-based rehabilitation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitation1 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) | Behavioural | Patients with Pulmonary Arterial Hypertension |
Primary outcome
Epigenetic factors influencing muscle metabolism
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Transcriptome analysis using RNA-seq
14 secondary outcomes
Intramyocellular lipid accumulation
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Muscular mitochondrial phosphorylation (ATP synthesis)
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Proportion of muscle fiber types
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
HbA1c
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Insulin
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Glucose
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Apolipoprotein A1
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Adiponectin
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Leptin
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Volitional strength quadriceps
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Non-volitional strength of the quadriceps
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Maximal exercise capacity
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Functional Exercise capacity
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Quality of life (QOL)
Time frame: Changes between baseline and 12 weeks of exercise rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Results publication: PubMed 22323570Grunig 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 in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
- Results publication: PubMed 26231884Ehlken 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, Grunig E. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016 Jan 1;37(1):35-44. doi: 10.1093/eurheartj/ehv337. Epub 2015 Jul 31.
- Results publication: PubMed 30578391Grunig E, Eichstaedt C, Barbera 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, Marra AM, McCaffrey N, McCaughey P, Naeije R, Olschewski H, Pepke-Zaba J, Reis A, Santos M, Saxer S, Tulloh RM, Ulrich S, Vonk Noordegraaf A, Peacock AJ. ERS statement on exercise training and rehabilitation in patients with severe chronic pulmonary hypertension. Eur Respir J. 2019 Feb 28;53(2):1800332. doi: 10.1183/13993003.00332-2018. Print 2019 Feb.
- Results publication: PubMed 24977625Potus F, Malenfant S, Graydon C, Mainguy V, Tremblay E, 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 hypertension. Am J Respir Crit Care Med. 2014 Aug 1;190(3):318-28. doi: 10.1164/rccm.201402-0383OC.
- Results publication: PubMed 29025748Malenfant 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;6(10):e006126. doi: 10.1161/JAHA.117.006126.
- Results publication: PubMed 25548805Malenfant S, Potus F, Fournier F, Breuils-Bonnet S, Pflieger A, Bourassa S, Tremblay E, Nehme 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):573-84. doi: 10.1007/s00109-014-1244-0. Epub 2014 Dec 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University Institute of Cardiology and Respirology of Quebec
Québec, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation in people with Pulmonary Arterial Hypertension and Exercise Training, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic factors influencing muscle metabolism (time frame: Changes between baseline and 12 weeks of exercise rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241497, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.