Pulmonary Arterial HypertensionPaRTAkE-PHNCT04254289
Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
A study testing Home-based exercise program in people with Pulmonary Arterial Hypertension, run by University of Michigan at 1 site in United States.
Trial summary
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Home-based exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2024to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28
- WHO functional class II to III
- Stable clinical condition, with no change in medical therapy for pulmonary arterial hypertension (PAH) for at least 3 months before enrollment
- Planned follow-up at University of Michigan Hospital Centers over at least 1 year
- If enrolled in clinical trial, must be in open-label extension stage on stable medications for at least 3 months.
- Competent to give informed consent
- Have computer and internet access
Who cannot join
- Life expectancy under 1 year
- Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia)
- Current substance abuse, and/or a severe psychiatric disorder (including severe depression, psychosis, or dementia) which limits the patient's ability to follow the study protocol
- Recently completed (<6 months), current enrollment or planned enrollment in pulmonary rehab.
- ≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months
- Six-minute walk distance <150 meters or >550 meters
Show all 12Show fewer
- Moderate or severe obstructive lung disease forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration).
- Moderate or severe restrictive lung disease (total lung capacity < 60% predicted value).
- Arterial oxygen saturation (SpO2) <88% during 6-minute walk test on baseline home oxygen prescription if applicable or SpO2 <80% if uncorrected shunt.
- History of exercise-induced syncope or arrhythmias.
- Pregnancy or lactation
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Usual Care, Home-based exercise program
- Keywords
- Exercise, Six-minute walk, Heart rate monitor
- Medical subject headings
- Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Usual care
Home-based exercise programBehavioural
Home-based program determined by exercise physiologist
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan. Receives: Behavioral: Usual Care |
| Home-based exercise program | Experimental | Home-based individualized exercise program based on heart rate reserve (HRR). Receives: Behavioral: Home-based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Distance measured in meters
Measured: Baseline, 12 weeks
Secondary outcomes (14)
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Distance measured in meters
Measured: Baseline, 6 months
Change in physical activity as measured by daily activity captured using the pedometer step count
average daily step counts measured by a pedometer
Measured: Baseline, 12 weeks
Change in physical activity as measured by daily activity captured using the pedometer step count
average daily step counts measured by a pedometer
Measured: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in treadmill exercise time
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.
Health related quality of life assessed using the EuroQol EQ-5D-5L. There is a descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
The survey visual analog scale (VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
The users guide gives details of the scoring system: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.
Health related quality of life assessed using the EuroQol EQ-5D-5L. There is a descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
The survey visual analog scale (VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
The users guide gives details of the scoring system: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf
Measured: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT™ questionnaire consists of four domains: Cardiopulmonary Symptoms Domain (scored 0-24), Cardiovascular Symptoms Domain (scored 0-20), Physical Impacts Domain (scored 0-28), and the Cognitive/Emotional Impacts Domain (scored 0-16). In each domain a higher score indicates worse symptoms.
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT™ questionnaire consists of four domains: Cardiopulmonary Symptoms Domain (scored 0-24), Cardiovascular Symptoms Domain (scored 0-20), Physical Impacts Domain (scored 0-28), and the Cognitive/Emotional Impacts Domain (scored 0-16). In each domain a higher score indicates worse symptoms.
Measured: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.
Measured: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
The PHQ-8 questionnaire about depression and is 8 items long. Each question ranges from 0 (not at all) to 3 (nearly every day) for a total possible score of 24 where higher score means more burdensome.
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
The PHQ-8 questionnaire about depression and is 8 items long. Each question ranges from 0 (not at all) to 3 (nearly every day) for a total possible score of 24 where higher score means more burdensome.
Measured: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
The World Health Organization (WHO) functional class system was created to define the severity of an individual's symptoms and how they impact on day-to-day activities. The functional classes range from I to IV with IV having worse daily impairments.
Measured: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
The World Health Organization (WHO) functional class system was created to define the severity of an individual's symptoms and how they impact on day-to-day activities. The functional classes range from I to IV with IV having worse daily impairments.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start11 Aug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Thomas Matthew Cascino, University of Michigan
- Investigators
- Thomas Cascino, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254289
- Sponsor's protocol ID
- HUM00150343
- Acronym
- PaRTAkE-PH
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2020
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04254289
- Acronym / sponsor ID
- PaRTAkE-PH / HUM00150343
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Exercise, Six-minute walk, Heart rate monitor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- 11 Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 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.
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareUsual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan. |
| Home-based exercise program | Experimental | Behavioral: Home-based exercise programHome-based individualized exercise program based on heart rate reserve (HRR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28
- WHO functional class II to III
- Stable clinical condition, with no change in medical therapy for pulmonary arterial hypertension (PAH) for at least 3 months before enrollment
- Planned follow-up at University of Michigan Hospital Centers over at least 1 year
- If enrolled in clinical trial, must be in open-label extension stage on stable medications for at least 3 months.
Key exclusion criteria (12 listed)
- Life expectancy under 1 year
- Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia)
- Current substance abuse, and/or a severe psychiatric disorder (including severe depression, psychosis, or dementia) which limits the patient's ability to follow the study protocol
- Recently completed (<6 months), current enrollment or planned enrollment in pulmonary rehab.
- ≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months
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 |
|---|---|---|
| Usual CareUsual care | Behavioural | Usual Care |
| Home-based exercise programHome-based program determined by exercise physiologist | Behavioural | Home-based exercise program |
Primary outcome
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Time frame: Baseline, 12 weeks
Distance measured in meters
14 secondary outcomes
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Time frame: Baseline, 6 months
Change in physical activity as measured by daily activity captured using the pedometer step count
Time frame: Baseline, 12 weeks
Change in physical activity as measured by daily activity captured using the pedometer step count
Time frame: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in treadmill exercise time
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.
Time frame: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
Time frame: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
Time frame: Baseline, 6 months
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
Time frame: Baseline, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Thomas Cascino, MD principal investigator
University of Michigan
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 exercise program in people with Pulmonary Arterial Hypertension, run by University of Michigan at 1 site in United States.
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 12 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: withdrawn, as of the sponsor's last update on 14 Aug 2024. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a home-based exercise training as measured by change in six-minute walk distance (time frame: Baseline, 12 weeks). 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 14 Aug 2024.