Back to resultsSupervised Endurance Training Among Pulmonary Arterial Hypertension Patients
Primary Purpose
Pulmonary Arterial Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Supervised endurance exercise training + Patient Education
Home exercises + Patient Education
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
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.
Sites / Locations
- Lady Reading hospitalRecruiting
- Peshawar Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supervised endurance exercise training + Patient Education
Home exercises + Patient Education
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05947032
First Posted
July 7, 2023
Last Updated
September 26, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05947032
Brief Title
Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients
Official Title
Effects of Supervised Endurance Training Versus Home-based Exercise Plan on Functional Capacity and Fatigue Among Pulmonary Arterial Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised endurance exercise training + Patient Education
Arm Type
Experimental
Arm Title
Home exercises + Patient Education
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Supervised endurance exercise training + Patient Education
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Home exercises + Patient Education
Intervention Description
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 Outcome Measure Information:
Title
Fatigue Severity Scale
Description
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
Title
Human Activity Profile
Description
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
Title
6MWT Distance
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Reading hospital
City
Peshawar
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Farheen Khan, MS
Facility Name
Peshawar Institute of Cardiology
City
Peshawar
State/Province
Khyber PkahtoonKhwa
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Farheen khan, MSPT*
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients
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