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

Primary Purpose

Pulmonary Arterial Hypertension

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual Care

Home-based exercise program

About this trial

This is an interventional supportive care trial for Pulmonary Arterial Hypertension focused on measuring Exercise, Six-minute walk, Heart rate monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Home-based exercise program

Arm Description

Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.

Home-based individualized exercise program based on heart rate reserve (HRR).

Outcomes

Primary Outcome Measures

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Distance measured in meters

Secondary Outcome Measures

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Distance measured in meters

Change in physical activity as measured by daily activity captured using the pedometer step count

average daily step counts measured by a pedometer

Change in physical activity as measured by daily activity captured using the pedometer step count

average daily step counts measured by a pedometer

Efficacy of a home-based exercise training as measured by change in treadmill exercise time

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

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.

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.

Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)

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.

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.

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.

Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8

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.

Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class

Full Information

NCT ID

NCT04254289

First Posted

February 2, 2020

Last Updated

September 28, 2023

Sponsor

University of Michigan

Collaborators

Actelion

1. Study Identification

Unique Protocol Identification Number

NCT04254289

Brief Title

Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Acronym

PaRTAkE-PH

Official Title

Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

Exercise, Six-minute walk, Heart rate monitor

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes 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.

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.

Arm Title

Home-based exercise program

Arm Type

Experimental

Arm Description

Home-based individualized exercise program based on heart rate reserve (HRR).

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

Usual care

Intervention Type

Behavioral

Intervention Name(s)

Home-based exercise program

Intervention Description

Home-based program determined by exercise physiologist

Primary Outcome Measure Information:

Title

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Description

Distance measured in meters

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Description

Distance measured in meters

Time Frame

Baseline, 6 months

Title

Change in physical activity as measured by daily activity captured using the pedometer step count

Description

average daily step counts measured by a pedometer

Time Frame

Baseline, 12 weeks

Title

Change in physical activity as measured by daily activity captured using the pedometer step count

Description

average daily step counts measured by a pedometer

Time Frame

Baseline, 6 months

Title

Efficacy of a home-based exercise training as measured by change in treadmill exercise time

Time Frame

Baseline, 12 weeks

Title

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.

Description

Time Frame

Baseline, 12 weeks

Title

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.

Description

Time Frame

Baseline, 6 months

Title

Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)

Description

Time Frame

Baseline, 12 weeks

Title

Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)

Description

Time Frame

Baseline, 6 months

Title

Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)

Description

The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.

Time Frame

Baseline, 12 weeks

Title

Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)

Description

The IPAQ-SF is 4 generic item questionnaire (7 questions). About physical activity time in the past 7 days.

Time Frame

Baseline, 6 months

Title

Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8

Description

Time Frame

Baseline, 12 weeks

Title

Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8

Description

Time Frame

Baseline, 6 months

Title

Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class

Description

Time Frame

Baseline, 12 weeks

Title

Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class

Description

Time Frame

Baseline, 6 months

Other Pre-specified Outcome Measures:

Title

Change in heart rate recovery

Time Frame

Baseline, 12 weeks

Title

Change in echocardiographic assessment of right ventricle size

Time Frame

Baseline, 12 weeks

Title

Change in echocardiographic assessment of right ventricle function

Time Frame

Baseline, 12 weeks

Title

Percent change in brain natriuretic peptide

Time Frame

Baseline, 12 weeks

Title

Change in number of low risk criteria

Description

Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance >440 m, brain natriuretic peptide (BNP) <50)

Time Frame

Baseline, 12 weeks

Title

Frequency of completion of activity logs

Time Frame

Up to 12 weeks

Title

Frequency of completion of weekly telephone follow-ups

Time Frame

Up to 12 weeks

Title

Number of low risk criteria

Description

Criteria include: World Health Organization (WHO) functional class I/II, six-minute walk distance >440 m, brain natriuretic peptide (BNP) <50

Time Frame

6 months

Title

Number of hospitalizations for pulmonary hypertension

Time Frame

12 weeks

Title

Number of hospitalizations for pulmonary hypertension

Time Frame

6 months

Title

Frequency of Death

Time Frame

Up to 12 weeks

Title

Frequency of Death

Time Frame

Up to 6 months

Title

Frequency worsening WHO functional class

Description

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.

Time Frame

12 weeks

Title

Frequency worsening World Health Organization (WHO) functional class

Description

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.

Time Frame

6 months

Title

Frequency of need for escalation of pulmonary hypertension therapy

Description

Escalation implies dose increase is define as increase of existing therapy or addition of new medication for pulmonary arterial hypertension.

Time Frame

Up to 12 weeks

Title

Frequency of need for escalation of pulmonary hypertension therapy

Description

Escalation implies dose increase is define as increase of existing therapy or addition of new medication for pulmonary arterial hypertension.

Time Frame

Up to 6 months

Title

Frequency of syncope

Time Frame

12 weeks

Title

Frequency of syncope

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Cascino, MD

Phone

734-232-0112

tcascino@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Cascino, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Cascino

Phone

734-232-0112

tcascino@umich.edu

First Name & Middle Initial & Last Name & Degree

Vallerie McLaughlin

12. IPD Sharing Statement

Plan to Share IPD

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