Protocol summary
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Study aim
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EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS
AND CHEST WALL EXPANSION IN COPD PATIENTS
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Design
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Two parallel group , single blinded, randomized control
trial with pre and post assessment
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Settings and conduct
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Pulmonology Ward District Headquarter Hospital Narowal
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Group A: will be treated by Pilates exercises with deep breathing
Group B: will be treated by core stabilization exercises with deep breathing
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Main outcome variables
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Assessment of pulmonary functions by using spirometer. tape measurement for chest wall expansion.
General information
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Reason for update
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due to some incomplete information
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Acronym
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IRCT registration information
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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
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Registration date
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2024-02-21, 1402/12/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-10, 1402/09/19
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Expected recruitment end date
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2024-04-10, 1403/01/22
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Actual recruitment start date
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2023-12-10, 1402/09/19
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Actual recruitment end date
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2024-04-10, 1403/01/22
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Trial completion date
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2024-07-10, 1403/04/20
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Scientific title
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EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS AND CHEST WALL EXPANSION IN COPD PATIENTS
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Public title
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EFFECTS OF PILATES VS CORE STABILIZATION EXERCISES ON PULMONARY FUNCTIONS AND CHEST WALL EXPANSION IN COPD PATIENTS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
54
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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It's a single blinded study as patients were blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-26, 1402/09/05
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Ethics committee reference number
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RCR&AHS/REC/MS-CPPT
Health conditions studied
1
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Description of health condition studied
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chronic obstructive pulmonary disease
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ICD-10 code
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J44.1
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ICD-10 code description
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Chronic obstructive pulmonary disease with (acute) exacerbation
Primary outcomes
1
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Description
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pulmonary functions
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Timepoint
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pre- Post treatment
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Method of measurement
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spirometer
2
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Description
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chest wall expansion
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Timepoint
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pre- Post treatment
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Method of measurement
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tape measurement
Intervention groups
1
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Description
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Intervention group: pilates exercises along with deep breathing
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Category
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Rehabilitation
2
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Description
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Intervention group: core stabilization exercises along with deep breathing
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Educational
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Riphah international university
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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there is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable