Hypertension, PulmonaryNCT02558582
Effect of Exercise Training in Patients With Pulmonary Hypertension
A study testing respiratory and exercise therapy and respiratory and exercise therapy with supplemental oxygen in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
Trial summary
Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- respiratory and exercise therapy and respiratory and exercise therapy with supplemental oxygen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2015to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO functional class II-IV
- PH diagnosed by right heart catheter showing:
- Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
- Baseline pulmonary vascular resistance (PVR) > 240 dyn x s x cm-5
- Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
- Patients receiving maximal PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study
Show all 9Show fewer
- PH target therapy should not be expected to change during the entire 15-week study period
- Negative pregnancy test (β-HCG) at the start of the trial
- Able to understand and willing to sign the Informed Consent Form
Who cannot join
- PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted)
- Pregnancy at study onset
- Walking disability
- Any change in disease-targeted therapy within the last 2 months
- Any subject who is scheduled to receive another investigational drug during the course of this study
- Any other relevant concomitant disease
- Systolic blood pressure < 85 mmHg
- History or suspicion of inability to cooperate adequately
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
UniversityHospital Zurich, Department of Pulmonology
Zurich, 8091
Silvia Ulrich Somaini, PD Dr., 0041442552220, silvia.ulrich@usz.ch
About this study
Official title: Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries
Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs.
Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension.
Read more
The main objectives of the present project are:
- to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month.
- to look whether training with hyperoxia vs. standard care might be more effective.
This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others.
In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training.
Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.
- Conditions
- Hypertension, Pulmonary
- Being tested
- respiratory and exercise therapy, respiratory and exercise therapy with supplemental oxygen
- Keywords
- Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Rehabilitation, Oxygen
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory and exercise therapyBehavioural
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
respiratory and exercise therapy with supplemental oxygenBehavioural
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Rehabilitation | Experimental | The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Receives: Behavioral: respiratory and exercise therapy |
| Immediate Rehabilitation with oxygen | Experimental | The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights. Receives: Behavioral: respiratory and exercise therapy with supplemental oxygen |
| Delayed Rehabilitation | Experimental | Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Receives: Behavioral: respiratory and exercise therapy |
| Delayed Rehabilitation with oxygen | Experimental | Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights. Receives: Behavioral: respiratory and exercise therapy with supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute walking test
Measured: Change from Baseline to 15 weeks
Constant cardiopulmonary exercise testing change in endurance time
Measured: Change from Baseline to 15 weeks
Secondary outcomes (8)
Quality of Life (questionnaire)
Minnesota living with heart failure questionnaire, Camphor, short form 36 item
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Sit-to-Stand (physiological parameter)
Number of Sit-to-Stand performed in 1 minute
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Stair Ascent (physiological parameter)
Force, Power and Time needed to climb 5 steps
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Cognitive function (questionnaire)
Trail Making Test A \& B, Stroop 1-3, 5 point test
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Hemodynamic (physiological parameter)
Pulmonary artery pressure, cardiac output
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Functional class (scale)
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Lung function (physiological parameter)
Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)
Actigraphy
Measured: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich Somaini, PD Dr., Principal investigator, UniversityHospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558582
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0231
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2015
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries
- ClinicalTrials.gov ID
- NCT02558582
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0231
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Rehabilitation, Oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- 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 Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs.
Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension.
The main objectives of the present project are:
- to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month.
- to look whether training with hyperoxia vs. standard care might be more effective.
This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others.
In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training.
Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate Rehabilitation | Experimental | Behavioral: respiratory and exercise therapyThe PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. |
| Immediate Rehabilitation with oxygen | Experimental | Behavioral: respiratory and exercise therapy with supplemental oxygenThe PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights. |
| Delayed Rehabilitation | Experimental | Behavioral: respiratory and exercise therapyWaiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. |
| Delayed Rehabilitation with oxygen | Experimental | Behavioral: respiratory and exercise therapy with supplemental oxygenWaiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- WHO functional class II-IV
- PH diagnosed by right heart catheter showing:
- Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
- Baseline pulmonary vascular resistance (PVR) > 240 dyn x s x cm-5
- Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
Key exclusion criteria (8 listed)
- PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted)
- Pregnancy at study onset
- Walking disability
- Any change in disease-targeted therapy within the last 2 months
- Any subject who is scheduled to receive another investigational drug during the course of this study
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 |
|---|---|---|
| respiratory and exercise therapyThe PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. | Behavioural | Delayed Rehabilitation, Immediate Rehabilitation |
| respiratory and exercise therapy with supplemental oxygenThe PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights. | Behavioural | Delayed Rehabilitation with oxygen, Immediate Rehabilitation with oxygen |
Primary outcome
6 Minute walking test
Time frame: Change from Baseline to 15 weeks
Constant cardiopulmonary exercise testing change in endurance time
Time frame: Change from Baseline to 15 weeks
8 secondary outcomes
Quality of Life (questionnaire)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Sit-to-Stand (physiological parameter)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Stair Ascent (physiological parameter)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Cognitive function (questionnaire)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Hemodynamic (physiological parameter)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Functional class (scale)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Lung function (physiological parameter)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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.
Silvia Ulrich Somaini, PD Dr. principal investigator
UniversityHospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory and exercise therapy and respiratory and exercise therapy with supplemental oxygen in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
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 9 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 2 Nov 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 Switzerland. 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 Silvia Ulrich Somaini, PD Dr. (0041442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute walking test (time frame: Change from Baseline to 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.