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Effects of Resistive Diaphragmatic Training on Chronic Stroke

Primary Purpose

Stroke (CVA) or TIA

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Incentive spirometer training
diaphragmatic resistance exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke (CVA) or TIA focused on measuring stroke, resistive diaphragmatic training, pulmonary function

Eligibility Criteria

40 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • District Hospital Sargodha

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Incentive spirometer training

diaphragmatic resistance exercises

Arm Description

Incentive spirometer training

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

Outcomes

Primary Outcome Measures

FEV1
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.
FVC
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.
Oxygen level in blood
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood
Heart Rate
Pulse oximetry is a test used to measure the heart rate

Secondary Outcome Measures

Full Information

First Posted
October 3, 2020
Last Updated
November 15, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04636658
Brief Title
Effects of Resistive Diaphragmatic Training on Chronic Stroke
Official Title
Effects of Resistive Diaphragmatic Training on Pulmonary Functions in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
September 1, 2020 (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
To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke (CVA) or TIA
Keywords
stroke, resistive diaphragmatic training, pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive spirometer training
Arm Type
Active Comparator
Arm Description
Incentive spirometer training
Arm Title
diaphragmatic resistance exercises
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Incentive spirometer training
Intervention Description
Incentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks
Intervention Type
Other
Intervention Name(s)
diaphragmatic resistance exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
FEV1
Description
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.
Time Frame
4th week
Title
FVC
Description
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.
Time Frame
4th week
Title
Oxygen level in blood
Description
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood
Time Frame
4th week
Title
Heart Rate
Description
Pulse oximetry is a test used to measure the heart rate
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Aftab, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Hospital Sargodha
City
Sargodha
State/Province
Punjab
ZIP/Postal Code
40100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Resistive Diaphragmatic Training on Chronic Stroke

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