Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension (PaRTAkE-PH)

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 Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Home-based exercise program

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Cascino, MD; Phone Number: 734-232-0112; Email: tcascino@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan
      • Contact: Thomas Cascino; Phone Number: 734-232-0112; Email: tcascino@umich.edu
      • Principal Investigator: Vallerie McLaughlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate recovery		Baseline, 12 weeks
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	Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance >440 m, brain natriuretic peptide (BNP) <50)	Baseline, 12 weeks
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	Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance >440 m, brain natriuretic peptide (BNP) <50	6 months
Number of hospitalizations for pulmonary hypertension		12 weeks
Number of hospitalizations for pulmonary hypertension		6 months
Frequency of Death		Up to 12 weeks
Frequency of Death		Up to 6 months
Frequency worsening WHO functional class	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.	12 weeks
Frequency worsening World Health Organization (WHO) functional class	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.	6 months
Frequency of need for escalation of pulmonary hypertension therapy	Escalation implies dose increase is define as increase of existing therapy or addition of new medication for pulmonary arterial hypertension.	Up to 12 weeks
Frequency of need for escalation of pulmonary hypertension therapy	Escalation implies dose increase is define as increase of existing therapy or addition of new medication for pulmonary arterial hypertension.	Up to 6 months
Frequency of syncope		12 weeks
Frequency of syncope		6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Actelion
• Investigators: Principal Investigator: Thomas Cascino, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Six-minute walk; Heart rate monitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: HUM00150343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No