Pulmonary Arterial HypertensionNCT05947032
Supervised Endurance Training Among Pulmonary Arterial Hypertension Patients
A study testing Supervised endurance exercise training + Patient Education and Home exercises + Patient Education in people with Pulmonary Arterial Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of supervised endurance training versus home based exercise plan on functional capacity and fatigue among pulmonary arterial hypertension patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Supervised endurance exercise training + Patient Education and Home exercises + Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supervised Endurance Training Versus Home-based Exercise Plan on Functional Capacity and Fatigue 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Supervised endurance exercise training + Patient Education, Home exercises + Patient Education
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised endurance exercise training + Patient EducationOther
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 EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Supervised endurance exercise training + Patient Education | Experimental | Not described Receives: Other: Supervised endurance exercise training + Patient Education |
| Home exercises + Patient Education | Active comparator | Not described Receives: Other: Home exercises + Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start20 Aug 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947032
- Sponsor's protocol ID
- REC/01603 Farheen Khan
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Endurance Training Versus Home-based Exercise Plan on Functional Capacity and Fatigue Among Pulmonary Arterial Hypertension Patients
- ClinicalTrials.gov ID
- NCT05947032
- Acronym / sponsor ID
- REC/01603 Farheen Khan
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of supervised endurance training versus home based exercise plan on functional capacity and fatigue among pulmonary arterial hypertension patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised endurance exercise training + Patient EducationENDURANCE 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 | Other | Supervised endurance exercise training + Patient Education |
| Home exercises + Patient EducationHOME 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 | Other | Home exercises + Patient Education |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised endurance exercise training + Patient Education and Home exercises + Patient Education in people with Pulmonary Arterial Hypertension, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.