Clinical trial NCT05063266: Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Official title: Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Muscle Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the progressive nature of pulmonary hypertension (PH), including the impairment of respiratory muscle function, studies have demonstrated beneficial effects of physical exercise on the functional limitations caused by the disease in this population, being an important collaborator to the conventional drug therapy.Respiratory muscle training (RMT) improves functional capacity and quality of life (QoL) in patients.A randomized controlled trial was conducted to evaluate the effectiveness of this protocol on respiratory muscle strength and endurance, functional capacity. 18 subjects were allocated in 2 groups, group A was control group and group B was experimental group. Group A or Control group received deep breathing exercises. Group B received 30 minutes of IMT 6days weekly for 2 weeks by using a pressure threshold device. The purpose of this study was to investigate the effects of inspiratory muscle training (IMT) in PAH. To evaluate effectiveness of IMT mouth pressure device ,functional capacity using 6 minute walking test (6MWT)health assessment via SF 36 questionnaire were used before and after training protocol.


Eligibility criteria: Inclusion Criteria:

Age group of 40 to 70 years.

* Both male and females will be included.
* Patients with a diagnosis of PH (PAPm ≥ 25mmHg and PAOP \<15mmHg);
* Clinically stable with augmented and unchanged daily medication therapy in the last three months; Subjects who agree to contribute in the research by signing a free and knowledgeable consent form.

Exclusion Criteria:

* COPD
* Severe ischemic heart disease
* Left heart failure;
* Cor pulmonale
* Cognitive disorders;
* Orthopedic problems; e.g;fracture in thoracic region.
* Emergency or elective surgical intervention during the protocol;
* Recent viral infections;

Primary outcomes:
measure: 6-min walk test (6 MWT)
timeFrame: 2nd week
measure: SF 36
timeFrame: 2nd week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fareeha kausar, PP-DPT
role: STUDY_CHAIR
References:
citation: Yuan P, Yuan XT, Sun XY, Pudasaini B, Liu JM, Hu QH. Exercise training for pulmonary hypertension: a systematic review and meta-analysis. Int J Cardiol. 2015 Jan 15;178:142-6. doi: 10.1016/j.ijcard.2014.10.161. Epub 2014 Oct 27. No abstract available.
citation: Chia KS, Wong PK, Faux SG, McLachlan CS, Kotlyar E. The benefit of exercise training in pulmonary hypertension: a clinical review. Intern Med J. 2017 Apr;47(4):361-369. doi: 10.1111/imj.13159.
citation: Becker-Grunig T, Klose H, Ehlken N, Lichtblau M, Nagel C, Fischer C, Gorenflo M, Tiede H, Schranz D, Hager A, Kaemmerer H, Miera O, Ulrich S, Speich R, Uiker S, Grunig E. Efficacy of exercise training in pulmonary arterial hypertension associated with congenital heart disease. Int J Cardiol. 2013 Sep 20;168(1):375-81. doi: 10.1016/j.ijcard.2012.09.036. Epub 2012 Oct 5.
citation: Saglam M, Arikan H, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Savci S, Akdogan A, Yokusoglu M, Kaya EB, Tokgozoglu L. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015 May-Jun;35(3):198-206. doi: 10.1097/HCR.0000000000000117.
citation: Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182.