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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Usual care
Home-based program determined by exercise physiologist
The University of Michigan
Ann Arbor, Michigan, United States
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Distance measured in meters
Time frame: Baseline, 12 weeks
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Distance measured in meters
Time frame: 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
Time frame: 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
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.
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
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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.
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
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)
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.
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)
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.
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)
The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.
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)
The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months