Chronic Thromboembolic Pulmonary HypertensionEXPECT-PHNCT05693779
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
A study testing Home exercise training in people with Chronic Thromboembolic Pulmonary Hypertension, run by University of Michigan.
Trial summary
This study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (CTEPH) patients following surgical or percutaneous intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Home exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients post-Pulmonary Thromboendarterectomy (PTE) or Balloon Pulmonary Angioplasty (BPA)
- Planned follow-up at Michigan Medicine for at least one year
- Has access to an Android or iPhone with study supported operating software, is willing to install MyDataHelps application, and is willing to wear a smart watch while awake
Who cannot join
- Life expectancy under 1 year
- Orthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training session
- Currently receiving palliative care and/or in hospice care
- Persistent severe Right Ventricular (RV) dysfunction on echocardiography post BPA or PTE
- Recently completed, current enrollment, or planned enrollment in pulmonary rehabilitation
- Moderate or severe obstructive lung disease or restrictive lung disease
Show all 14Show fewer
- Arterial oxygen saturation (SpO2) <88% during 6 minute walk test(6MWT) on baseline home oxygen prescription
- Wrist too large to wear a smart watch comfortably.
- Participant noted to wear smart watch for less than 8 hours per day prior to intervention.
- Determined to be unsafe for participation in exercise therapy as assessed by the clinical team.
- Those with mobility issues that are unable to complete 6MWT.
- Participant has sex minute walk distance (6MWD) greater or equal to 90% predicted at visit 1.
- Pregnancy or lactation
- Non-English speaking
About this study
Official title: Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: EXPECT-PH
This study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (CTEPH) patients following surgical or percutaneous intervention. Eligible participants will be enrolled and have a 12 week home based exercise training program.
The study team hypothesizes that:
Read more
The following percentage of participants successfully complete the ramp-up phase of the exercise program:
- Greater or equal to 70% at end of week 7
- Greater or equal to 80% at end of week 10
- Greater or equal to 90% at end of week 12
- Greater or equal to 80% of participants will both complete ≥1 week of maintenance phase exercise and complete 12 weeks of the exercise intervention.
- Patients will have no adverse events, defined as syncope, worsening World Health Organization (WHO) functional class, pulmonary hypertension (PH) related hospitalization, or death, caused by the exercise intervention.
- Being tested
- Home exercise training
- Keywords
- Exercise, Balloon pulmonary angioplasty, Pulmonary thromboendarterectomy, Smart watch, Treadmill exercise test
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise trainingBehavioural
Participants will complete an Exercise Treadmill Test at baseline. The 12 weeks exercise program that will be assigned to each patient will be based on these results. The exercise will be three 20-minute exercise sessions per week for 6 weeks. This will increase to four 60-minute exercise sessions per week at increased intensity progressively over the course of the exercise program. The exercise program will involve walking/jogging, elliptical training, or biking 3-4 times per week for up to an hour each session. If participants don't have access to a bike or elliptical, they will be asked to exercise by walking/jogging.
Participants will also a phone call or video chat that takes about 15 minutes per week to discuss the exercise program and take 2 short surveys weekly on the MyDataHelps application and filling out a logbook recording exercise sessions. In addition, participants activity will be measured by using a smartwatch during the study.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise training | Experimental | Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data. Receives: Behavioral: Home exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
Based on intervention weeks 1-7. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Measured: Week 7
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
Based on intervention weeks 1-10. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Measured: Week 10
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
Based on intervention weeks 1-12. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Measured: Week 12
Secondary outcomes (1)
Number of adverse events
These will be defined as hospitalization due to CTEPH-specific decompensation, worsening World Health Organization (WHO) functional class, syncope, and death.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study startMay 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Administrative Changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brahmajee K Nallamothu, University of Michigan
- Investigators
- Vikas Aggarwal, MD, Principal investigator, University of MichiganBramajee Nallamothu, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693779
- Sponsor's protocol ID
- HUM00214495
- Acronym
- EXPECT-PH
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2023
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: EXPECT-PH
- ClinicalTrials.gov ID
- NCT05693779
- Acronym / sponsor ID
- EXPECT-PH / HUM00214495
- Keywords
- Exercise, Balloon pulmonary angioplasty, Pulmonary thromboendarterectomy, Smart watch, Treadmill exercise test
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative Changes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 23 Jan 2023 (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.
This study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (CTEPH) patients following surgical or percutaneous intervention. Eligible participants will be enrolled and have a 12 week home based exercise training program.
The study team hypothesizes that:
The following percentage of participants successfully complete the ramp-up phase of the exercise program:
- Greater or equal to 70% at end of week 7
- Greater or equal to 80% at end of week 10
- Greater or equal to 90% at end of week 12
- Greater or equal to 80% of participants will both complete ≥1 week of maintenance phase exercise and complete 12 weeks of the exercise intervention.
- Patients will have no adverse events, defined as syncope, worsening World Health Organization (WHO) functional class, pulmonary hypertension (PH) related hospitalization, or death, caused by the exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home exercise training | Experimental | Behavioral: Home exercise trainingIndividualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients post-Pulmonary Thromboendarterectomy (PTE) or Balloon Pulmonary Angioplasty (BPA)
- Planned follow-up at Michigan Medicine for at least one year
- Has access to an Android or iPhone with study supported operating software, is willing to install MyDataHelps application, and is willing to wear a smart watch while awake
Key exclusion criteria (14 listed)
- Life expectancy under 1 year
- Orthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training session
- Currently receiving palliative care and/or in hospice care
- Persistent severe Right Ventricular (RV) dysfunction on echocardiography post BPA or PTE
- Recently completed, current enrollment, or planned enrollment in pulmonary rehabilitation
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 exercise trainingParticipants will complete an Exercise Treadmill Test at baseline. The 12 weeks exercise program that will be assigned to each patient will be based on these results. The exercise will be three 20-minute exercise sessions per week for 6 weeks. This will increase to four 60-minute exercise sessions per week at increased intensity progressively over the course of the exercise program. The exercise program will involve walking/jogging, elliptical training, or biking 3-4 times per week for up to an hour each session. If participants don't have access to a bike or elliptical, they will be asked to exercise by walking/jogging. Participants will also a phone call or video chat that takes about 15 minutes per week to discuss the exercise program and take 2 short surveys weekly on the MyDataHelps application and filling out a logbook recording exercise sessions. In addition, participants activity will be measured by using a smartwatch during the study. | Behavioural | Home exercise training |
Primary outcome
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
Time frame: Week 7
Based on intervention weeks 1-7. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
Time frame: Week 10
Based on intervention weeks 1-10. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
Time frame: Week 12
Based on intervention weeks 1-12. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
1 secondary outcome
Number of adverse events
Time frame: 12 weeks
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 7 Jun 2023.
- 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.
Vikas Aggarwal, MD principal investigator
University of Michigan
Bramajee Nallamothu, MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise training in people with Chronic Thromboembolic Pulmonary Hypertension, run by University of Michigan.
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 3 inclusion and 14 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention (time frame: Week 7). The study lists 3 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 7 Jun 2023.