Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

NCT05947032 | Completed DMC

• 1 other identifier: REC/01603 Farheen Khan
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Supervised endurance exercise training + Patient Education

EXPERIMENTAL

Other: Supervised endurance exercise training + Patient Education

Home exercises + Patient Education

ACTIVE COMPARATOR

Other: Home exercises + Patient Education

Interventions

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

Supervised endurance exercise 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

Home exercises + Patient Education

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Lady Reading hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Muhammad Iqbal Tariq, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: August 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)