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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • 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

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
Intervention / Treatment
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

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

Riphah International University

Investigators

  • 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)

September 1, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Stroke, Ischemic

Clinical Trials on Resistive Diaphragmatic breathing exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe