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CompletedNCT05063266Updated Oct 1, 2021

Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient

An interventional study of Deep Breathing Exercise and Inspiratory muscle Training in Inspiratory Muscle Training, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2020, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Inspiratory Muscle Training
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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.

This study's enrollment of 18 is below the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Group A

    Deep Breathing exercise

    Other: Deep Breathing Exercise

  • Experimental
    Group B

    Inspiratory Muscle Training

    Other: Inspiratory muscle Training

Interventions

  • OtherDeep Breathing Exercise

    control groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing.

  • OtherInspiratory muscle Training

    Treatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device.

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What researchers measure

Primary outcomes

  1. 6-min walk test (6 MWT)

    The 6-min walk test (6 MWT) is a submaximal exercise test drive that includes measurement of distance walked throughout a period of 6 minutes. The 6-minute walk distance (6 MWD) stipulates a measure for collective global retort of multiple cardiopulmonary and musculoskeletal structures involved in workout.The 6 MWT provides information about functional capacity, response to rehabilitation and prognosis slanting a broad range of chronic cardiopulmonary situations. Main strengths of the 6 MWT curb from its simplicity in conception and performing, low cost, ease of consistency, and acceptance by test individuals, including those who are deconditioned, aged, or fragile.

    Time frame: 2nd week

  2. SF 36

    SF-36 is a setting of universal, clear, and easily instructed quality-of-life methods. These measures hang on upon patient self-reporting and are now widely utilized by trained care groups and by Medicare for everyday observing and assessment of care findings in mature patient role

    Time frame: 2nd week

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Study locations

1 site
  • Services Hospital
    Lahore, Punjab 54000, Pakistan
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References and documents

Publications

  • 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. PubMed 25464238 ↗
  • 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. PubMed 27338855 ↗
  • 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. PubMed 23041100 ↗
  • 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. PubMed 25909652 ↗
  • 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. PubMed 25395284 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05063266
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Oct 13, 2020
Primary completion
Jul 2, 2021
Completion
Jul 15, 2021
Last update
Oct 1, 2021

Study contacts

Fareeha kausar, PP-DPT
study chair · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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