Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients

March 17, 2024 updated by: Riphah International University

Effect of Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise on Pulmonary Function, Trunk Control and Functional Capacity in Sub-acute Stroke Patients

To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Peshawar, Punjab, Pakistan, 44000
        • Northwest General Hospital, Peshawar;

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 40-65 years
  • Onset of ischemic stroke in first two week
  • First episode of unilateral stroke with hemiparesis during previous 12 months
  • Patient with no serious cognitive deficits i-e mini-mental state examination (score >22) ability to understand, perform and follow simple verbal instructions
  • Functional ambulation category (FAC) >3
  • 6 min walk test distance should be >200 m

Exclusion Criteria:

  • Known case of cardiopulmonary disease, BP > 180/100 mmHg twice in 24 hours
  • Known case of neurological disease other than stroke, Known case of orthopedic disease i-e funnel chest, rib fractures or any other orthopedic deformity
  • Medication that would influence metabolic or cardiorespiratory responses to exercise Impaired level of consciousness, Evidence of gross cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment A
  1. Resistive Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Resistive Diaphragmatic breathing exercise
  1. Resistive Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Diaphragmatic breathing exercise
  1. Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Conventional stroke physiotherapy
Conventional stroke physiotherapy
Active Comparator: Treatment B
  1. Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Resistive Diaphragmatic breathing exercise
  1. Resistive Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Diaphragmatic breathing exercise
  1. Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Conventional stroke physiotherapy
Conventional stroke physiotherapy
Active Comparator: Control group
a) Conventional stroke physiotherapy
Other: Resistive Diaphragmatic breathing exercise
  1. Resistive Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Diaphragmatic breathing exercise
  1. Diaphragmatic breathing exercise
  2. Pursed lips breathing exercise
  3. Conventional stroke physiotherapy
Other: Conventional stroke physiotherapy
Conventional stroke physiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pulmonary function
Time Frame: 4 weeks
The pulmonary functions Spirometer measure can be expressed as Forced Expiratory Volume in 1 second (FEV1) and Force Vital Capacity (FVC) .
4 weeks
Trunk Control
Time Frame: 4weeks

Trunk performance and coordination by static and dynamic sitting balance was measured by TIS.TIS comprises 17 items, measures dynamic and static sitting balance and trunk co-ordination. The TIS total score is 0-23 points, higher scores show better performance.

It takes about 6 to 16 minutes in applying TIS
4weeks
Functional Capacity
Time Frame: 4weeks

6 MWT is used for functional capacity of participants, by walking for 6 minutes.

Participant walk between the point marked, as numerous periods as can in 6 minutes.

The 6-minute walk (6mw) test is a reliable and valid measure of for assessing functional capacity.
4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Razzaq, MS, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/014220 Muhammad Iqbal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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