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Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient

Primary Purpose

Inspiratory Muscle Training

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep Breathing Exercise
Inspiratory muscle Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inspiratory Muscle Training

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Services Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Deep Breathing exercise

Inspiratory Muscle Training

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2021
Last Updated
September 23, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05063266
Brief Title
Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Official Title
Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

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
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspiratory Muscle Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Deep Breathing exercise
Arm Title
Group B
Arm Type
Experimental
Arm Description
Inspiratory Muscle Training
Intervention Type
Other
Intervention Name(s)
Deep Breathing Exercise
Intervention Description
control groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle Training
Intervention Description
Treatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device.
Primary Outcome Measure Information:
Title
6-min walk test (6 MWT)
Description
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
Title
SF 36
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25464238
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.
Results Reference
background
PubMed Identifier
27338855
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.
Results Reference
background
PubMed Identifier
23041100
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.
Results Reference
background
PubMed Identifier
25909652
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.
Results Reference
background
PubMed Identifier
25395284
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.
Results Reference
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Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient

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