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Completed

NCT Number: NCT05947032

Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

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

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Reading hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised endurance exercise training + Patient Education

Other

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

Home exercises + Patient Education

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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