search
Back to results

Effects of UE Aerobic Exercise on Exercise Capacity and PA in Patients With Pulmonary Arterial Hypertension.

Primary Purpose

Pulmonary Arterial Hypertension (PAH)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
aerobic exercises
active alternating movements for the upper limbs
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension (PAH) focused on measuring Upper Extremity Aerobic Exercise Training;, ; Exercise Capacity; Rehabilitation

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National hospital and Ittefaq hospital in Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

upper extremity aerobic exercises

active alternating movements for the upper limbs a

Arm Description

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 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.

Outcomes

Primary Outcome Measures

6 MWT
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.
Borg rating of perceived exertion (RPE)
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05947240
Brief Title
Effects of UE Aerobic Exercise on Exercise Capacity and PA in Patients With Pulmonary Arterial Hypertension.
Official Title
Effects of Upper Extremity Aerobic Exercise on Exercise Capacity and Physical Activity in Patients With Pulmonary Arterial Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 15, 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension (PAH)
Keywords
Upper Extremity Aerobic Exercise Training;, ; Exercise Capacity; Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
upper extremity aerobic exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
active alternating movements for the upper limbs a
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aerobic exercises
Intervention Description
The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist.
Intervention Type
Other
Intervention Name(s)
active alternating movements for the upper limbs
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 MWT
Description
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.
Time Frame
4 weeks
Title
Borg rating of perceived exertion (RPE)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Tariq, PHD
Phone
O3338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National hospital and Ittefaq hospital in Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Phone
03022001847
Email
sidra.faisal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Syeda Hina Zahra, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33853885
Citation
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.
Results Reference
background
PubMed Identifier
31663077
Citation
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.
Results Reference
background
PubMed Identifier
36078768
Citation
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.
Results Reference
background
PubMed Identifier
32498263
Citation
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.
Results Reference
background
PubMed Identifier
33972341
Citation
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.
Results Reference
background
PubMed Identifier
32642177
Citation
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.
Results Reference
background

Learn more about this trial

Effects of UE Aerobic Exercise on Exercise Capacity and PA in Patients With Pulmonary Arterial Hypertension.

We'll reach out to this number within 24 hrs