Pulmonary Arterial Hypertension
Conditions
Keywords
Exercise, Six-minute walk, Heart rate monitor
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.
Interventions
BEHAVIORALUsual Care
Usual care
BEHAVIORALHome-based exercise program
Home-based program determined by exercise physiologist
Sponsors
Actelion
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
An independent statistician will develop the randomization schedule and an unblinded study team member will document and maintain the treatment assignment log. The investigators will be adjusting the exercise regimens of those randomized to the exercise program and are unable to be blinded. All patients will receive weekly telephone calls to review activity logs. Outcomes included in the primary and secondary analysis will be blinded as possible. The staff performing the 6-minute walk test (6MWT) and interpreting echocardiograms will be blinded to the group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of a home-based exercise training as measured by change in six-minute walk distance | Baseline, 12 weeks | Distance measured in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity as measured by daily activity captured using the pedometer step count | Baseline, 12 weeks | average daily step counts measured by a pedometer |
| Efficacy of a home-based exercise training as measured by change in treadmill exercise time | 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. | Baseline, 12 weeks | 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 |
| Efficacy of a home-based exercise training as measured by change in six-minute walk distance | Baseline, 6 months | Distance measured in meters |
| Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF) | Baseline, 12 weeks | The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days. |
| Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8 | Baseline, 12 weeks | 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. |
| Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class | Baseline, 12 weeks | 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. |
| Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) | Baseline, 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Death | Up to 12 weeks | — |
| Frequency worsening WHO functional class | 12 weeks | WHO functional class higher than previously noted. 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. |
| Change in heart rate recovery | Baseline, 12 weeks | — |
| Frequency of need for escalation of pulmonary hypertension therapy | Up to 12 weeks | Escalation implies dose increase is define as increase of existing therapy or addition of new medication for pulmonary arterial hypertension. |
| Frequency of syncope | 12 weeks | — |
| Frequency worsening World Health Organization (WHO) functional class | 6 months | WHO functional class higher than previously noted. The 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. |
| Change in echocardiographic assessment of right ventricle size | Baseline, 12 weeks | — |
| Change in echocardiographic assessment of right ventricle function | Baseline, 12 weeks | — |
| Percent change in brain natriuretic peptide | Baseline, 12 weeks | — |
| Change in number of low risk criteria | Baseline, 12 weeks | Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance \>440 m, brain natriuretic peptide (BNP) \<50) |
| Frequency of completion of activity logs | Up to 12 weeks | — |
| Frequency of completion of weekly telephone follow-ups | Up to 12 weeks | — |
| Number of low risk criteria | 6 months | Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance \>440 m, brain natriuretic peptide (BNP) \<50 |
| Number of hospitalizations for pulmonary hypertension | 12 weeks | — |
Countries
United States
Outcome results
None listed