History
# Registration date Revision Id
2 2024-07-18, 1403/04/28 308754
1 2024-02-21, 1402/12/02 295241
Changes made to previous revision
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  • General information

    18
    empty
    Year
    empty
    No
    Yes
    40
    empty
    Year
    empty
    No
    Yes
    Not blinded
    Single blinded
    1
    empty
    due to some incomplete information
    It's a single blinded study as patients were blinded.
  • Health conditions studied

    #1
    empty
    J44.1
    empty
    Chronic obstructive pulmonary disease with (acute) exacerbation
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: Riphah college of rehabilitation & Allied Health Sciences
    Full name of responsible person - Persian:
    Street address - English: 13-14-C-civic center, township near Hamdard Chowk, Lahore
    Street address - Persian:
    City - English: Lahore
    City - Persian:
    Province: punjab
    Country: Pakistan
    Postal code: 54000
    Phone: +92 42 35126110
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: wajeeha
    Full name of responsible person - Persian:
    Street address - English: 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
    Street address - Persian:
    City - English: Lahore
    City - Persian:
    Province: punjab
    Country: Pakistan
    Postal code: 54600
    Phone: +92 42 35126110
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saima Arshad
    Full name of responsible person - Persian:
    Position - English: student
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 13-14-C-civic center, township near Hamdard Chowk, Lahore
    Street address - Persian:
    City - English: lahore
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54000
    Phone: +92 42 35126110
    Mobile: +92 42 35126110
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saima Arshad
    Full name of responsible person - Persian:
    Position - English: student
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: village Aima qazian, tehsil & district Narowal
    Street address - Persian:
    City - English: narowal
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 51601
    Phone: +92 346 6646556
    Mobile: +92 346 6646556
    Fax:
    Email: saimaarshad893@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saima Arshad
    Full name of responsible person - Persian:
    Position - English: student
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 13-14-C-civic center, township near Hamdard Chowk, Lahore
    Street address - Persian:
    City - English: lahore
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54000
    Phone: +92 42 35126110
    Mobile: +92 42 35126110
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Riphah international university
    Name of organization / entity - Persian:
    Full name of responsible person - English: Wajeeha
    Full name of responsible person - Persian:
    Position - English: senior lecturer
    Position - Persian:
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
    Street address - Persian:
    City - English: lahore
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54660
    Phone: +92 42 35126110
    Mobile: +92 323 4500788
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Riphah international University
    Name of organization / entity - Persian:
    Full name of responsible person - English: saima Arshad
    Full name of responsible person - Persian:
    Position - English: student
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 13-14-C-civic center, township near Hamdard Chowk, Lahore
    Street address - Persian:
    City - English: lahore
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54000
    Phone: +92 42 35126110
    Mobile: +92 42 35126110
    Fax:
    Email: wajeeha_z@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Riphah international University
    Name of organization / entity - Persian:
    Full name of responsible person - English: saima Arshad
    Full name of responsible person - Persian:
    Position - English: student
    Position - Persian:
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
    Street address - Persian:
    City - English: lahore
    City - Persian:
    Province: punjab
    Province - English: punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 54660
    Phone: +92 42 35126110
    Mobile: +92 346 6646556
    Fax:
    Email: saimaarshad893@gmail.com
    Web page address:

Protocol summary

Study aim
EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS AND CHEST WALL EXPANSION IN COPD PATIENTS
Design
Two parallel group , single blinded, randomized control trial with pre and post assessment
Settings and conduct
Pulmonology Ward District Headquarter Hospital Narowal
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients with stable COPD Male & female age >18 years Able to walk independently Ability to perform voluntary given exercise program Did not participate in any training program during the last six months Exclusion criteria Unstable COPD >4 months hospital admissions due to COPD during last 1 year cognitive impairments  progressive neuromuscular disease Spinal cord Injuries or severe orthopedic problems cardiovascular
Intervention groups
Group A: will be treated by Pilates exercises with deep breathing Group B: will be treated by core stabilization exercises with deep breathing
Main outcome variables
Assessment of pulmonary functions by using spirometer. tape measurement for chest wall expansion.

General information

Reason for update
due to some incomplete information
Acronym
IRCT registration information
IRCT registration number: IRCT20191117045462N12
Registration date: 2024-02-21, 1402/12/02
Registration timing: registered_while_recruiting

Last update: 2024-07-21, 1403/04/31
Update count: 1
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-10, 1402/09/19
Expected recruitment end date
2024-04-10, 1403/01/22
Actual recruitment start date
2023-12-10, 1402/09/19
Actual recruitment end date
2024-04-10, 1403/01/22
Trial completion date
2024-07-10, 1403/04/20
Scientific title
EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS AND CHEST WALL EXPANSION IN COPD PATIENTS
Public title
EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS AND CHEST WALL EXPANSION IN COPD PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with stable COPD Male & female age >18 years Able to walk independently Ability to perform voluntary given exercise program Did not participate in any training program during the last six months
Exclusion criteria:
Unstable COPD >4 months hospital admissions due to COPD during last 1 year cognitive impairments Spinal cord Injuries or severe orthopedic problems cardiovascular conditions progressive neuromuscular disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Actual sample size reached: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited by convenient sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as 0 for Group A and for 1 group B
Blinding (investigator's opinion)
Single blinded
Blinding description
It's a single blinded study as patients were blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
RCR&AHS/REC/MS-CPPT

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation

Primary outcomes

1

Description
pulmonary functions
Timepoint
pre- Post treatment
Method of measurement
spirometer

2

Description
chest wall expansion
Timepoint
pre- Post treatment
Method of measurement
tape measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pilates exercises along with deep breathing
Category
Rehabilitation

2

Description
Intervention group: core stabilization exercises along with deep breathing
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 346 6646556
Email
saimaarshad893@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
riphah international university
Full name of responsible person
wajeeha
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54600
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah international university
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Saima Arshad
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
village Aima qazian, tehsil & district Narowal
City
narowal
Province
punjab
Postal code
51601
Phone
+92 346 6646556
Email
saimaarshad893@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Wajeeha
Position
senior lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
lahore
Province
punjab
Postal code
54660
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah international University
Full name of responsible person
saima Arshad
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
lahore
Province
punjab
Postal code
54660
Phone
+92 42 35126110
Email
saimaarshad893@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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