Clinical trial NCT05947240: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension (PAH)
Keywords: Upper Extremity Aerobic Exercise Training;
; Exercise Capacity; Rehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 6 MWT
timeFrame: 4 weeks
measure: Borg rating of perceived exertion (RPE)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: National hospital and Ittefaq hospital in Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Faisal, MS.CPPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.