Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: Home exercises + Patient Education; Other: Supervised endurance exercise training + Patient Education

• Registration Number: NCT05947032
• Lead Sponsor: Riphah International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-14
• Study Start: 2023-08-20
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home exercises + Patient Education	Home exercises + Patient Education	-
Supervised endurance exercise training + Patient Education	Supervised endurance exercise training + Patient Education	-

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	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	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	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.

Trial Locations

Locations (1)

Lady Reading hospital; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan