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CompletedNCT05947032Updated Mar 5, 2024

Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

An interventional study of Supervised endurance exercise training + Patient Education and Home exercises + Patient Education in Pulmonary Arterial Hypertension, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 50 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Supervised endurance exercise training + Patient Education

    Other: Supervised endurance exercise training + Patient Education

  • Active comparator
    Home exercises + Patient Education

    Other: Home exercises + Patient Education

Interventions

  • OtherSupervised endurance exercise training + Patient Education

    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

  • OtherHome exercises + Patient Education

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • Lady Reading hospital
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05947032
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Aug 20, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Mar 5, 2024

Study contacts

Muhammad Iqbal Tariq, PhD*
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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