Clinical trial NCT04254289: Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
Official title: Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Exercise
Six-minute walk
Heart rate monitor
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2020-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Efficacy of a home-based exercise training as measured by change in six-minute walk distance
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Efficacy of a home-based exercise training as measured by change in six-minute walk distance
timeFrame: Baseline, 6 months
measure: Change in physical activity as measured by daily activity captured using the pedometer step count
timeFrame: Baseline, 12 weeks
measure: Change in physical activity as measured by daily activity captured using the pedometer step count
timeFrame: Baseline, 6 months
measure: Efficacy of a home-based exercise training as measured by change in treadmill exercise time
timeFrame: Baseline, 12 weeks
measure: 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.
timeFrame: Baseline, 12 weeks
measure: 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.
timeFrame: Baseline, 6 months
measure: Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
timeFrame: Baseline, 12 weeks
measure: Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
timeFrame: Baseline, 6 months
measure: Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Baseline, 12 weeks
measure: Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Baseline, 6 months
measure: Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
timeFrame: Baseline, 12 weeks
measure: Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8
timeFrame: Baseline, 6 months
measure: Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
timeFrame: Baseline, 12 weeks
measure: Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in heart rate recovery
timeFrame: Baseline, 12 weeks
measure: Change in echocardiographic assessment of right ventricle size
timeFrame: Baseline, 12 weeks
measure: Change in echocardiographic assessment of right ventricle function
timeFrame: Baseline, 12 weeks
measure: Percent change in brain natriuretic peptide
timeFrame: Baseline, 12 weeks
measure: Change in number of low risk criteria
timeFrame: Baseline, 12 weeks
measure: Frequency of completion of activity logs
timeFrame: Up to 12 weeks
measure: Frequency of completion of weekly telephone follow-ups
timeFrame: Up to 12 weeks
measure: Number of low risk criteria
timeFrame: 6 months
measure: Number of hospitalizations for pulmonary hypertension
timeFrame: 12 weeks
measure: Number of hospitalizations for pulmonary hypertension
timeFrame: 6 months
measure: Frequency of Death
timeFrame: Up to 12 weeks
measure: Frequency of Death
timeFrame: Up to 6 months
measure: Frequency worsening WHO functional class
timeFrame: 12 weeks
measure: Frequency worsening World Health Organization (WHO) functional class
timeFrame: 6 months
measure: Frequency of need for escalation of pulmonary hypertension therapy
timeFrame: Up to 12 weeks
measure: Frequency of need for escalation of pulmonary hypertension therapy
timeFrame: Up to 6 months
measure: Frequency of syncope
timeFrame: 12 weeks
measure: Frequency of syncope
timeFrame: 6 months
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Thomas Cascino, MD
role: PRINCIPAL_INVESTIGATOR
References: