- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947240
Effects of UE Aerobic Exercise on Exercise Capacity and PA in Patients With Pulmonary Arterial Hypertension.
Effects of Upper Extremity Aerobic Exercise on Exercise Capacity and Physical Activity in Patients With Pulmonary Arterial Hypertension.
Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.
Intervention will be for 3 times a week or 6 weeks. The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min, 3 times/week over 6 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.
Intervention will be for 3 times a week or 6 weeks. The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min, 3 times/week over 6 weeks. This study will measure and record HR by using the heart rate monitor, oxygen saturation (SpO2) by using pulse oximetry and blood pressure, breathing frequency (BF), dyspnea, fatigue, and arm fatigue by using MBS before, during, and after training.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iqbal Tariq, PHD
- Phone Number: O3338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- National hospital and Ittefaq hospital in Lahore
-
Contact:
- Sidra Faisal, MS.CPPT
- Phone Number: 03022001847
- Email: sidra.faisal@riphah.edu.pk
-
Principal Investigator:
- Syeda Hina Zahra, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient diagnosed with pulmonary arterial hypertension.
- Both the sex was considered.
- Age range from 35 to 60 years.
- Patients who were stable.
- Patient under optimal medical therapy for at least three months before participating in this study
- Willing to participate in study (13).
Exclusion Criteria:
- Patient with cognitive disorders.
- Patient with orthopedic or neurological diseases. acute infection or pneumonia
- Patient with class IV heart failure.
- Patient with acute infection or pneumonia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: upper extremity aerobic exercises
The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist.
Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min,3 times/week over 6 weeks.
|
The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist.
|
Experimental: active alternating movements for the upper limbs a
The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.
Intervention will be for 3 times a week or 6 weeks.
|
The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.
Intervention will be for 3 times a week or 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 MWT
Time Frame: 4 weeks
|
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).The self-paced 6MWT assesses the submaximal level of functional capacity.
|
4 weeks
|
Borg rating of perceived exertion (RPE)
Time Frame: 4 weeks
|
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription.
It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training.Borg RPE scale was developed by Gunnar Borg for rating exertion and breathlessness during physical activity ; that is, how hard the activity is as shown by high heart and respiration rate , profuse perspiration and muscle exertion.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Faisal, MS.CPPT, Riphah International University
Publications and helpful links
General Publications
- Malenfant S, Lebret M, Breton-Gagnon E, Potus F, Paulin R, Bonnet S, Provencher S. Exercise intolerance in pulmonary arterial hypertension: insight into central and peripheral pathophysiological mechanisms. Eur Respir Rev. 2021 Apr 13;30(160):200284. doi: 10.1183/16000617.0284-2020. Print 2021 Jun 30.
- Karapolat H, Cinar ME, Tanigor G, Nalbantgil S, Kayikcioglu M, Mogulkoc N, Kultursay H. Effects of cardiopulmonary rehabilitation on pulmonary arterial hypertension: A prospective, randomized study. Turk J Phys Med Rehabil. 2019 May 8;65(3):278-286. doi: 10.5606/tftrd.2019.2758. eCollection 2019 Sep.
- Cedeno de Jesus S, Almadana Pacheco V, Valido Morales A, Muniz Rodriguez AM, Ayerbe Garcia R, Arnedillo-Munoz A. Exercise Capacity and Physical Activity in Non-Cystic Fibrosis Bronchiectasis after a Pulmonary Rehabilitation Home-Based Programme: A Randomised Controlled Trial. Int J Environ Res Public Health. 2022 Sep 3;19(17):11039. doi: 10.3390/ijerph191711039.
- Waller L, Kruger K, Conrad K, Weiss A, Alack K. Effects of Different Types of Exercise Training on Pulmonary Arterial Hypertension: A Systematic Review. J Clin Med. 2020 Jun 2;9(6):1689. doi: 10.3390/jcm9061689.
- McCormack C, Kehoe B, Hardcastle SJ, McCaffrey N, McCarren A, Gaine S, McCullagh B, Moyna N. Pulmonary hypertension and home-based (PHAHB) exercise intervention: protocol for a feasibility study. BMJ Open. 2021 May 10;11(5):e045460. doi: 10.1136/bmjopen-2020-045460.
- Zeng X, Chen H, Ruan H, Ye X, Li J, Hong C. Effectiveness and safety of exercise training and rehabilitation in pulmonary hypertension: a systematic review and meta-analysis. J Thorac Dis. 2020 May;12(5):2691-2705. doi: 10.21037/jtd.2020.03.69.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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