Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

Study Overview
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Brief Summary
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To compare the effects of supervised endurance training versus home based exercise plan on functional capacity and fatigue among pulmonary arterial hypertension patients.

Official Title
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Effects of Supervised Endurance Training Versus Home-based Exercise Plan on Functional Capacity and Fatigue Among Pulmonary Arterial Hypertension Patients

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Other: Supervised endurance exercise training + Patient Education
* Other: Home exercises + Patient Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pulmonary arterial hypertension, not pregnant and tobacco free. Age = 21 to 82 Patients with documented PAH diagnosed by echocardiography (enlarged RA an enlarged RV with a thick wall, septal shift by enlarged chambers of right side of heart, an elevated mPAP) or a resting mean pulmonary arterial pressure equal to 25mm Hg determined by right heart catheterization. Patients on stable PH therapies, sedentary, and had no pulmonary rehabilitation for 6 months prior to enrolment. Exclusion Criteria: Patients will be excluded if they are not able to complete 6MWT. A documented pulmonary capillary wedge pressure greater then or equal to 15 mm Hg. Significant hepatic, renal, metabolic or mitochondrial dysfunctions; severe psychiatric disease; use of beta-adrenergic blockers or antiretroviral therapies; and any musculoskeletal or neurological condition that would limit walking or exercise performance. Patients with a history of heart failure.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised endurance exercise training + Patient Education<br> | Other: Supervised endurance exercise training + Patient Education<br>* ENDURANCE TRAINING: Treadmill Walking: Frequency: 15 to 20 sessions for 3 to 5 days per week. Intensity: 40% to 60% of HRR Time: 15 Min Type: aerobic training Recumbent Bike: Frequency: 15 to 20 sessions for 3 to 5 days/week. Intensity: 40% to 60% HRR Time: 15 Min Type: aerobic training + Patient Education<br>|
| Active Comparator: Home exercises + Patient Education<br> | Other: Home exercises + Patient Education<br>* HOME EXERCISES: CONVENTIONAL Treatment: Walking: Frequency: 2 times/ day Intensity: as tolerated Time: 30 Min Type: aerobic training Stair climbing: Frequency: 1 flight/ day Type: aerobic training + Patient Education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | It measures the patient's perception of the influence of fatigue on physical and social functioning through patient's response to nine different question. Scoring is based on likert scale where 1 indicates strong agreement and 7 indicates strong disagreement. A score of 4 or greater is indicative of severe fatigue. | 4 weeks | 
| Human Activity Profile | A questionnaire to assess the activity level of patient in rehabilitation with a total no of 94 questions I ascending order based on metabolic demands. For each activity mentioned patient will be asked 1) if they are still doing this activity 2) have stopped doing this activity or never did this activity. HAP generates two scores the maximum activity score MAS and adjusted activity score ASS. Score < 53 is considered as low activity score between 54-73 stands for intermediate activity for high activity score > 74 is required respectively. | 4 weeks | 
| 6MWT Distance | Subject walks as fast as they can for 6 mins on a walking track to determine their ability to participate in physical activity.The 6 MWT is scored as the total distance covered in the 6-min duration of the test. it will be measured in meters. | 4 weeks |