Effects of Resistive Diaphragmatic Training on Chronic Stroke

November 15, 2020 updated by: Riphah International University

Effects of Resistive Diaphragmatic Training on Pulmonary Functions in Patients With Chronic Stroke

To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to examine the effects of Diaphragmatic breathing exercises with resistance and Digital spirometer training for improving pulmonary functions in chronic stroke patients. Diaphragmatic Resistance training is based on the same principal as for the any other Skeletal Muscle training. The selection of 20 subjects divided equally and placed into an experimental group and a control group and the interventions would applied three times per week for 4 weeks. In each session, both groups receive Digital spirometer training for 15 minutes. In addition, experimental group receive diaphragm breathing exercises with resistance for 30 minutes. Resistance is Applied through Different thera bands and then performing the Breathing Exercises. First of all resistance applied through yellow band(1-6 pounds of resistance) and then red, Green and black which give (4-18 Pounds of resistance) The patient is asked to breath in deeply and slowly while not to move upper chest .Weight increased weekly as per patient's tolerance. Further Digital spirometer training Perform to determine the Pulmonary Functions FVC,FEV1,FVC/FEV1,PEF,VC. in both Control and Experimental Groups

Study Type

Interventional

Enrollment (Actual)

20

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
      • Sargodha, Punjab, Pakistan, 40100
        • District Hospital Sargodha

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

40 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age limit 40-50yrs both genders.
  • Stroke patients with compromised pulmonary functions.
  • Chronic stroke patients with impaired Breathing

Exclusion Criteria:

  • Patients having any systemic illness
  • Patients who have a damage accompanying orthopedic disease such as thoracic deformation or rib fracture.
  • Patients with stroke (less than 6 months duration)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Incentive spirometer training
Other: Incentive spirometer training
Incentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks
EXPERIMENTAL: diaphragmatic resistance exercises
Incentive spirometer training with diaphragm breathing with resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient
Other: diaphragmatic resistance exercises

Incentive spirometer with diaphragmatic resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient.

Digital spirometer training for 15 minutes. diaphragm breathing exercises with resistance for 30 minutes. 5 sessions a week, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: 4th week
FEV1 is the amount of air you can force from your lungs in one second. It's measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine.
4th week
FVC
Time Frame: 4th week
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function.
4th week
Oxygen level in blood
Time Frame: 4th week
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood
4th week
Heart Rate
Time Frame: 4th week
Pulse oximetry is a test used to measure the heart rate
4th week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Anam Aftab, Phd*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 15, 2020

Primary Completion (ACTUAL)

August 20, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 15, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00237 Bushra Mushtaq

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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