Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05947032
Collaborator
(none)
50
2
2
4
25
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Supervised endurance exercise training + Patient Education
  • Other: Home exercises + Patient Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Supervised Endurance Training Versus Home-based Exercise Plan on Functional Capacity and Fatigue Among Pulmonary Arterial Hypertension Patients
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supervised endurance exercise training + Patient Education

Other: Supervised 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

Active Comparator: Home exercises + Patient Education

Other: Home 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lady Reading hospital Peshawar Khyber Pakhtunkhwa Pakistan 25000
2 Peshawar Institute of Cardiology Peshawar Khyber PkahtoonKhwa Pakistan 25000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05947032
Other Study ID Numbers:
  • Farheen Khan
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2023