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Completed

NCT Number: NCT05063266

Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient

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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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Deep Breathing Exercise

Other

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

Inspiratory Muscle Training

Other

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

Primary outcomes

  1. 6-min walk test (6 MWT)

    Time frame: 2nd week

    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.

  2. SF 36

    Time frame: 2nd week

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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