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Clinical Trials/NCT05947032
NCT05947032
Completed
Not Applicable

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

Riphah International University1 site in 1 country50 target enrollmentAugust 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Riphah International University
Enrollment
50
Locations
1
Primary Endpoint
Fatigue Severity Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 20, 2023
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Fatigue Severity Scale

Time Frame: 4 weeks

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.

6MWT Distance

Time Frame: 4 weeks

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.

Human Activity Profile

Time Frame: 4 weeks

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.

Study Sites (1)

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