Protocol summary

Study aim
The aim of this study is to evaluate the effect of ACBT exercises on airway clearance in COVID-19 patients and to fill the research gap for both studies that will help patients in future to deal with post COVID complications more conveniently with cost effective procedures.
Design
100 covid-19 patients from both ICU and indoor were taken. ACBT treatment was applied. No placebo effect was used. Non randomized, no biasness and not blinded.
Settings and conduct
study was conducted in ICU and indoor wards of different hospitals with proper use of PPE-protective personal equipment's.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients having the age range from 30-60 were selected. Patients who were admitted to ICU or COVID indoor patients were included. Patients who were conscious were selected for this study. Exclusion criteria: Individuals below age 30, without COVID or with other comorbidities were prohibited from our review. Patients with decreased awareness and conscious level were not included in the assortment criteria. Patients admitted to CCU were excluded
Intervention groups
A total of 100 patients were recruited including both males and females. They were taken for the application of active cycles of breathing techniques in different Indoors and ICU units from multiple hospitals in Lahore city. Prior to exercise subjects were evaluated with the help of a standardized questionnaire i.e. Interventions Evaluation on COVID-19 patients-Questionnaire. After getting the active cycles of breathing techniques patients were again evaluated with the Interventions Evaluation on COVID-19 patients-Questionnaire. All registered subjects were informed of the study protocol.
Main outcome variables
Oxygen saturation, Breathing rate, Forced expiratory volume, Body temperature, heart rate and blood pressure were important variables because they fluctuate differently in both gender

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220825055791N1
Registration date: 2022-09-15, 1401/06/24
Registration timing: retrospective

Last update: 2022-09-15, 1401/06/24
Update count: 0
Registration date
2022-09-15, 1401/06/24
Registrant information
Name
Anam Yousaf
Name of organization / entity
Government College University Faisalabad
Country
Pakistan
Phone
+92 310 4722300
Email address
anamyousaf13@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-24, 1401/02/04
Expected recruitment end date
2022-05-17, 1401/02/27
Actual recruitment start date
2022-04-24, 1401/02/04
Actual recruitment end date
2022-05-17, 1401/02/27
Trial completion date
2022-05-17, 1401/02/27
Scientific title
Assessment of effect of active cycle of breathing techniques (ACBT) on airway clearance in covid-19 patients
Public title
effect of active cycle of breathing techniques (ACBT) in covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having the age range from 30-60 were selected. Patients who were admitted to ICU or COVID indoor patients were included. Patients who were conscious were selected for this study.
Exclusion criteria:
Individuals below age 30, without COVID or with other comorbidities were prohibited from our review. Patients with decreased awareness and conscious level were not included in the assortment criteria. Patients admitted to CCU were excluded.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
One hundred COVID-19 patients, age group 30-60 years from both indoor and ICU were involved in this research.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Afro-Asian Institute
Street address
43-52 Khayaban-e-Kareem Rd, Near Nishter Metro Station
City
Lahore
Postal code
54000
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
AAI/IRB/DPT/2022/00149

Health conditions studied

1

Description of health condition studied
In this research Coronavirus (COVID-19) pandemic was studied. Patients with Obstructive pulmonary disease that is corona was studied to observe the ACBT treatment plan. Previous studies have shown that incidence of COVID-19 has increased more effectively among both gender ranges from 43% male and 57% female. Approximately, major population suffered with COVID-19 report fever, shortness of breath, cough, tachypnea, chest tightness, dyspnea, chills, high-grade temperature and even death.
ICD-10 code
U07
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Pre outcomes were breathing rate 48 breath pre minute. After interventions application results were improved breathing rate was 16-20 breath pre minute which was like normal people.
Timepoint
In this study patients were checked before and after the ACBT interventions applied. symptoms of berating compilation were assessed. cough, dyspnea, shortness of breath. The treatment application time was 2 weeks. Patient history was taken prior to treatment and after 2 weeks treatment plan.
Method of measurement
The patient examination was performed before and after the treatment by using the tool Interventions Evaluation on COVID-19 patients-Questionnaire to assess the impact of Coronavirus on people and exercises effects on airways clearance.

2

Description
Temperature was raised up to (103F) which represents body immune system activation against virus or other foreign agent. after treatment application temperature reduced to optimal level that is 37F.
Timepoint
In this study patients were checked before and after the ACBT interventions applied. Fever/pyrexia was the initial sign along with oxygen level during corona patient diagnosis. The treatment application time was 2 weeks. Patient history was taken prior to treatment and after 2 weeks treatment plan.
Method of measurement
The patient examination was performed before and after the treatment by using the tool Interventions Evaluation on COVID-19 patients-Questionnaire to assess the impact of Coronavirus on people and exercises effects on airways clearance.

3

Description
O2 saturation was less than 75% -80% before treatment applied an after treatment application O2 improve to >90%. ACBT proved more beneficial for COVID-19 patients.
Timepoint
In this study patients were checked before and after the ACBT interventions applied. O2 saturation vital sign was checked in corona patients every 24-hours because most deadly agent was oxygen vital. The treatment application time was 2 weeks. Patient history was taken prior to treatment and after 2 weeks treatment plan.
Method of measurement
The patient examination was performed before and after the treatment by using the tool Interventions Evaluation on COVID-19 patients-Questionnaire to assess the impact of Coronavirus on people and exercises effects on airways clearance.

Secondary outcomes

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Intervention groups

1

Description
Control group: COVID-19 population was targeted. Total 100 patients were taken. In this study pre and post vitals and required information history was taken. 2 groups was involved. One group is labelled as pre- group with no intervention applied and severe COVID-19 symptoms. The prior vitals then compared with post vitals after 2 weeks of treatment application to check outcome results. Procedure repeated 2- times a week. Treatment method was Active cycle of breathing techniques, use to reduced the pulmonary symptoms.
Category
Treatment - Other

2

Description
Intervention group: COVID-19 population was targeted. Total 100 patients were taken. 2nd group was labelled as Post- group and vitals and required information history was taken after 2 weeks of treatment application to check outcome results. Procedure repeated 2- times a week. Treatment method was Active cycle of breathing techniques, use to reduced the pulmonary symptoms. results compared to the prior vitals were 96% more satisfactory and ACBT proved beneficial for airway clearance in COVID-19 patients.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jinnah hospital
Full name of responsible person
Anam Yousaf
Street address
Shahdara lahore khadim colony street no.5
City
Lahore
Postal code
Shahdara lahore khad
Phone
+92 310 4722300
Email
anamyousaf13@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Govt. college university of Faisalabad
Full name of responsible person
Anam Yousaf
Street address
street no. 05, khadim colony, shahdara, lahore.
City
Lahore
Postal code
street no. 05, khadi
Phone
+92 310 4722300
Email
anamyousaf13@gmail.com
Grant name
Anam Yousaf
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Govt. college university of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Govt. college university of Faisalabad
Full name of responsible person
Anam Yousaf
Position
medical student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
street no. 05, khadim colony, shahdara, lahore.
City
Lahore
Province
Punjab
Postal code
street no. 05, khadi
Phone
+92 310 4722300
Email
anamyousaf13@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Govt. college university of Faisalabad
Full name of responsible person
Anam Yousaf
Position
medical student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
street no. 05, khadim colony, shahdara, lahore.
City
Lahore
Province
Punjab
Postal code
street no. 05, khadi
Phone
+92 310 7722300
Email
anamyousaf13@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Govt. college university of Faisalabad
Full name of responsible person
Anam Yousaf
Position
Medical student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahdara lahore khadim colony street no.5
City
Lahore
Province
Punjab
Postal code
Shahdara lahore khad
Phone
+92 310 4722300
Email
anamyousaf13@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Assessment of effect of active cycle of breathing techniques (ACBT) on airway clearance in covid-19 patients
When the data will become available and for how long
starting 6 months after publication.
To whom data/document is available
This only available for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
it is an cosile study and researchers can approach this article by simply entering the MESH keys.
From where data/document is obtainable
For communication means contact anamyousaf13@gmail.com.
What processes are involved for a request to access data/document
contact via mail or number mentioned.
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