Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: Home-based exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan. | Behavioral: Usual Care<br>* Usual care<br>|
| Experimental: Home-based exercise program<br>Home-based individualized exercise program based on heart rate reserve (HRR). | Behavioral: Home-based exercise program<br>* Home-based program determined by exercise physiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a home-based exercise training as measured by change in six-minute walk distance | Distance measured in meters | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a home-based exercise training as measured by change in six-minute walk distance | Distance measured in meters | 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 | 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 | Baseline, 6 months | 
| 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. | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Six-minute walk, Heart rate monitor