Pulmonary Arterial HypertensionNCT05655481
Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial
A study testing Aerobic and Resistance training with rehabilitation and Health education in people with Pulmonary Arterial Hypertension and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Pulmonary arterial hypertension (PAH) is a serious, progressive disease that causes pulmonary arterial pressure, significantly affecting functional capacity and quality of life. Over the last few years, knowledge in pulmonary hypertension has evolved consistently and significantly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease Nursing
- What is being tested?
- Aerobic and Resistance training with rehabilitation and Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2023to 10 May 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with PAH from group 1 of the HP leaderboard
- Confirmed diagnosis of PAH by cardiac catheterization measurements as defined in group 1, with NHNY functional class I to IV (receiving specific pharmacological therapy for PAH), aged 18 to 70 years
- They are clinically stable without having been hospitalized in the last few weeks.
- Having internet with a data package and knowing how to use WhatsApp to manage telerehabilitation
Who cannot join
- Requiring continuous oxygen therapy
- Clinical groups 3, 4 and 5
- Significant musculoskeletal disease or limb claudication pain; Psychological or cognitive impairment, psychiatric psychological or mood disorders that may affect your ability to perform the clinical field test
- History of moderate or severe chronic lung disease
- Left heart disease, angina and/or fast heart rate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Luciana Maria Malosa Sampaio
São Paulo, São Paulo, 03332010
Luciana Malosa Sampaio, PhD
About this study
Official title: Effects of a Home Telerehabilitation Program Via Videoconference in Patients With Pulmonary Arterial Hypertension- Randomized Clinical Trial
Pulmonary arterial hypertension (PAH) is a serious, progressive disease that causes pulmonary arterial pressure, significantly affecting functional capacity and quality of life.
Over the last few years, knowledge in pulmonary hypertension has evolved consistently and significantly. New diagnostic and treatment algorithms were combined based on the results of several clinical studies that showed the usefulness of new tools, as well as the effectiveness of new drugs as well as non-pharmacological treatment. The new guidelines felt the benefits of physical exercise in individuals with PAH, with promising results in improving symptoms, exercise capacity, peripheral muscle function and quality of life.
Read more
With the COVID 19 pandemic, the complex scenario was for world health, and social distancing made it impossible to carry out individual outpatient rehabilitation, in groups and in person, indicating the need for rehabilitation programs, including physical training, to be adapted to the domicile.
New alternative modes of pulmonary rehabilitation include home-based models and the use of telehealth. Telerehabilitation is the provision of rehabilitation services at a distance, using information and communication technologies. To date, there has been no evaluation of the clinical efficacy or safety of telerehabilitation in the population affected by PAH.
Read the detailed description
Pulmonary arterial hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
In one form of pulmonary hypertension, called PAH, blood vessels in the lungs are narrowed, blocked or destroyed. The damage slows blood flow through the lungs, and blood pressure in the lung arteries rises. The heart must work harder to pump blood through the lungs. The extra effort eventually causes the heart muscle to become weak and fail. In some people, pulmonary hypertension slowly gets worse and can be life-threatening. Although there's no cure for some types of pulmonary hypertension, treatment can help reduce symptoms and improve quality of life.
Several studies show the importance of physical training in patients with PAH. In the study by Meirelles et al. individuals with severe chronic PAH achieved positive results when manifested to physical training, improved the distance walked in the 6-minute walk test (6MWD) by 96±61m after 15 weeks compared to the control group (p<0.001) and several other studies point out the importance of aerobic training for this pulmonary hypertension (PH) population.
However, it is known that exercise limitation in PAH is multifactorial, having right ventricular dysfunction, chronotropic incompetence, ventilatory abnormalities and skeletal muscle dysfunction as causes. mechanical restrictions, poor oxygenation of the skeletal and cerebral muscle, hyperventilation with variations/or increase in the sympathetic impulse.
- Conditions
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease Nursing, Hypertension, Pulmonary, Pulmonary Hypertension
- Being tested
- Aerobic and Resistance training with rehabilitation, Health education
- Keywords
- Exercise Functional Capacity, Pulmonary Arterial Hypertension, Telerehabilitation, Functional Capacity
- Medical subject headings
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and Resistance training with rehabilitationOther
Effects of home telerehabilitation program improve functional capacity variables
Health educationOther
Telehealth and guidelines for the practice of physical activity and health education
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | AEROBIC TRAINING
2 training sessions per week for a period of 8 weeks
Connection platform: WhatsApp
The research participant will use a 20 cm step on which he will have to go up and down until he reaches the predicted training heart rate.
Intensity: 60-80% of the maximum heart rate reached at the peak of the incremental step test
5 minutes warm-up: 60% of maximum heart rate
20 minutes of Training: 60 to 80% of the maximum heart rate reached at the peak of the incremental step test
5 minute cool down: 60% of maximum heart rate
Duration 30 minutes
RESISTANCE TRAINING
Devices: Anklet (variable load), these devices will be made available to the research participant
Exercises for upper limbs, shoulder flexion, elbow flexion and shoulder abduction, and for lower limbs hip flexion and extension.
Intensity: 70% of the maximum starting load of a 1RM repetition
3 sets of 8 repetitions
Duration: 30 minutes Receives: Other: Aerobic and Resistance training with rehabilitation |
| Telehealth | Experimental | Guidelines leaflet with health education proposals Explanations about your disease, what it is, psychopathological diagnoses and pharmacological and non-pharmacological treatment), information about the importance of physical activity in your daily life, such as walking, stretching or some daily physical activity according to your preference .
This group will not receive aerobic or resistance training.
You will receive telemonitoring twice a week over a period of 8 weeks as a form of teleconsultation in health with the physiotherapist for monitoring throughout the research.
After this period it will be reassessed. Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Oxygen consumption measured during cardiopulmonary testing
Measured: Change from baseline to 8 weeks
6 Minute Walking Test
Distance in meters
Measured: Change from baseline to 8 weeks
Maximum heart rate
Correlate the maximum heart rate of both functional capacity tests
Measured: Change from baseline to 8 weeks
Interchangeable tests
Correlate the distance covered in the six-minute walk test with the number of climbs in the incremental step test
Measured: Change from baseline to 8 weeks
Secondary outcomes (3)
FVC
Lung function - forced vital capacity
Measured: Change from baseline to 8 weeks
FEV1
Lung function - expiratory volume in 1 second
Measured: Change from baseline to 8 weeks
Health-related quality of life score
scores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start15 Jan 2023 (estimated)
- Primary completion25 Apr 2023 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Luciana Malosa Sampaio, Ph.D, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655481
- Sponsor's protocol ID
- PAH - Telerehabilitation
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandey A, Garg S, Khunger M, Garg S, Kumbhani DJ, Chin KM, Berry JD. Efficacy and Safety of Exercise Training in Chronic Pulmonary Hypertension: Systematic Review and Meta-Analysis. Circ Heart Fail. 2015 Nov;8(6):1032-43. doi: 10.1161/CIRCHEARTFAILURE.115.002130. Epub 2015 Jul 16.
PubMed 26185169Buys R, Avila A, Cornelissen VA. Exercise training improves physical fitness in patients with pulmonary arterial hypertension: a systematic review and meta-analysis of controlled trials. BMC Pulm Med. 2015 Apr 22;15:40. doi: 10.1186/s12890-015-0031-1.
PubMed 25896259Ehlken 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 26231884Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
PubMed 16982941Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Pradella CO, Belmonte GM, Maia MN, Delgado CS, Luise AP, Nascimento OA, Gazzotti MR, Jardim JR. Home-Based Pulmonary Rehabilitation for Subjects With COPD: A Randomized Study. Respir Care. 2015 Apr;60(4):526-32. doi: 10.4187/respcare.02994. Epub 2014 Sep 30.
PubMed 25269680Maron BA, Hess E, Maddox TM, Opotowsky AR, Tedford RJ, Lahm T, Joynt KE, Kass DJ, Stephens T, Stanislawski MA, Swenson ER, Goldstein RH, Leopold JA, Zamanian RT, Elwing JM, Plomondon ME, Grunwald GK, Baron AE, Rumsfeld JS, Choudhary G. Association of Borderline Pulmonary Hypertension With Mortality and Hospitalization in a Large Patient Cohort: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. Circulation. 2016 Mar 29;133(13):1240-8. doi: 10.1161/CIRCULATIONAHA.115.020207. Epub 2016 Feb 12.
PubMed 26873944Desai SA, Channick RN. Exercise in patients with pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):12-6. doi: 10.1097/01.HCR.0000311502.57022.73.
PubMed 18277824Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
PubMed 32229541
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home Telerehabilitation Program Via Videoconference in Patients With Pulmonary Arterial Hypertension- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05655481
- Acronym / sponsor ID
- PAH - Telerehabilitation
- Conditions
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease Nursing, Hypertension, Pulmonary, Pulmonary Hypertension
- Keywords
- Exercise Functional Capacity, Pulmonary Arterial Hypertension, Telerehabilitation, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 25 Apr 2023 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 19 Dec 2022 (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 (PAH) is a serious, progressive disease that causes pulmonary arterial pressure, significantly affecting functional capacity and quality of life.
Over the last few years, knowledge in pulmonary hypertension has evolved consistently and significantly. New diagnostic and treatment algorithms were combined based on the results of several clinical studies that showed the usefulness of new tools, as well as the effectiveness of new drugs as well as non-pharmacological treatment. The new guidelines felt the benefits of physical exercise in individuals with PAH, with promising results in improving symptoms, exercise capacity, peripheral muscle function and quality of life.
With the COVID 19 pandemic, the complex scenario was for world health, and social distancing made it impossible to carry out individual outpatient rehabilitation, in groups and in person, indicating the need for rehabilitation programs, including physical training, to be adapted to the domicile.
New alternative modes of pulmonary rehabilitation include home-based models and the use of telehealth. Telerehabilitation is the provision of rehabilitation services at a distance, using information and communication technologies. To date, there has been no evaluation of the clinical efficacy or safety of telerehabilitation in the population affected by PAH.
Detailed description
Pulmonary arterial hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
In one form of pulmonary hypertension, called PAH, blood vessels in the lungs are narrowed, blocked or destroyed. The damage slows blood flow through the lungs, and blood pressure in the lung arteries rises. The heart must work harder to pump blood through the lungs. The extra effort eventually causes the heart muscle to become weak and fail. In some people, pulmonary hypertension slowly gets worse and can be life-threatening. Although there's no cure for some types of pulmonary hypertension, treatment can help reduce symptoms and improve quality of life.
Several studies show the importance of physical training in patients with PAH. In the study by Meirelles et al. individuals with severe chronic PAH achieved positive results when manifested to physical training, improved the distance walked in the 6-minute walk test (6MWD) by 96±61m after 15 weeks compared to the control group (p<0.001) and several other studies point out the importance of aerobic training for this pulmonary hypertension (PH) population.
However, it is known that exercise limitation in PAH is multifactorial, having right ventricular dysfunction, chronotropic incompetence, ventilatory abnormalities and skeletal muscle dysfunction as causes. mechanical restrictions, poor oxygenation of the skeletal and cerebral muscle, hyperventilation with variations/or increase in the sympathetic impulse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Aerobic and Resistance training with rehabilitationAEROBIC TRAINING 2 training sessions per week for a period of 8 weeks Connection platform: WhatsApp The research participant will use a 20 cm step on which he will have to go up and down until he reaches the predicted training heart rate. Intensity: 60-80% of the maximum heart rate reached at the peak of the incremental step test 5 minutes warm-up: 60% of maximum heart rate 20 minutes of Training: 60 to 80% of the maximum heart rate reached at the peak of the incremental step test 5 minute cool down: 60% of maximum heart rate Duration 30 minutes RESISTANCE TRAINING Devices: Anklet (variable load), these devices will be made available to the research participant Exercises for upper limbs, shoulder flexion, elbow flexion and shoulder abduction, and for lower limbs hip flexion and extension. Intensity: 70% of the maximum starting load of a 1RM repetition 3 sets of 8 repetitions Duration: 30 minutes |
| Telehealth | Experimental | Other: Health educationGuidelines leaflet with health education proposals Explanations about your disease, what it is, psychopathological diagnoses and pharmacological and non-pharmacological treatment), information about the importance of physical activity in your daily life, such as walking, stretching or some daily physical activity according to your preference . This group will not receive aerobic or resistance training. You will receive telemonitoring twice a week over a period of 8 weeks as a form of teleconsultation in health with the physiotherapist for monitoring throughout the research. After this period it will be reassessed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with PAH from group 1 of the HP leaderboard
- Confirmed diagnosis of PAH by cardiac catheterization measurements as defined in group 1, with NHNY functional class I to IV (receiving specific pharmacological therapy for PAH), aged 18 to 70 years
- They are clinically stable without having been hospitalized in the last few weeks.
- Having internet with a data package and knowing how to use WhatsApp to manage telerehabilitation
Key exclusion criteria (5 listed)
- Requiring continuous oxygen therapy
- Clinical groups 3, 4 and 5
- Significant musculoskeletal disease or limb claudication pain; Psychological or cognitive impairment, psychiatric psychological or mood disorders that may affect your ability to perform the clinical field test
- History of moderate or severe chronic lung disease
- Left heart disease, angina and/or fast heart rate.
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 |
|---|---|---|
| Aerobic and Resistance training with rehabilitationEffects of home telerehabilitation program improve functional capacity variables | Other | Telerehabilitation |
| Health educationTelehealth and guidelines for the practice of physical activity and health education | Other | Telehealth |
Primary outcome
Functional exercise capacity
Time frame: Change from baseline to 8 weeks
Oxygen consumption measured during cardiopulmonary testing
6 Minute Walking Test
Time frame: Change from baseline to 8 weeks
Distance in meters
Maximum heart rate
Time frame: Change from baseline to 8 weeks
Correlate the maximum heart rate of both functional capacity tests
Interchangeable tests
Time frame: Change from baseline to 8 weeks
Correlate the distance covered in the six-minute walk test with the number of climbs in the incremental step test
3 secondary outcomes
FVC
Time frame: Change from baseline to 8 weeks
FEV1
Time frame: Change from baseline to 8 weeks
Health-related quality of life score
Time frame: Change from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Results publication: PubMed 26185169Pandey A, Garg S, Khunger M, Garg S, Kumbhani DJ, Chin KM, Berry JD. Efficacy and Safety of Exercise Training in Chronic Pulmonary Hypertension: Systematic Review and Meta-Analysis. Circ Heart Fail. 2015 Nov;8(6):1032-43. doi: 10.1161/CIRCHEARTFAILURE.115.002130. Epub 2015 Jul 16.
- Results publication: PubMed 25896259Buys R, Avila A, Cornelissen VA. Exercise training improves physical fitness in patients with pulmonary arterial hypertension: a systematic review and meta-analysis of controlled trials. BMC Pulm Med. 2015 Apr 22;15:40. doi: 10.1186/s12890-015-0031-1.
- 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 16982941Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
- Results publication: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Results publication: PubMed 25269680Pradella CO, Belmonte GM, Maia MN, Delgado CS, Luise AP, Nascimento OA, Gazzotti MR, Jardim JR. Home-Based Pulmonary Rehabilitation for Subjects With COPD: A Randomized Study. Respir Care. 2015 Apr;60(4):526-32. doi: 10.4187/respcare.02994. Epub 2014 Sep 30.
- Results publication: PubMed 26873944Maron BA, Hess E, Maddox TM, Opotowsky AR, Tedford RJ, Lahm T, Joynt KE, Kass DJ, Stephens T, Stanislawski MA, Swenson ER, Goldstein RH, Leopold JA, Zamanian RT, Elwing JM, Plomondon ME, Grunwald GK, Baron AE, Rumsfeld JS, Choudhary G. Association of Borderline Pulmonary Hypertension With Mortality and Hospitalization in a Large Patient Cohort: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. Circulation. 2016 Mar 29;133(13):1240-8. doi: 10.1161/CIRCULATIONAHA.115.020207. Epub 2016 Feb 12.
- Results publication: PubMed 18277824Desai SA, Channick RN. Exercise in patients with pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):12-6. doi: 10.1097/01.HCR.0000311502.57022.73.
- Results publication: PubMed 32229541Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 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.
Luciana Malosa Sampaio, Ph.D principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and Resistance training with rehabilitation and Health education in people with Pulmonary Arterial Hypertension and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
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 4 inclusion and 5 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 21 Dec 2022. 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 Brazil. 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?
Contact Luciana Malosa Sampaio, Ph.D (+5511996002075, lucianamalosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: Change from baseline to 8 weeks). The study lists 4 primary outcomes in all. 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 NCT05655481, which also lists 9 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 21 Dec 2022.