Primary Objective: To evaluate the effects of arm crank exercises on Dyspnea, Left Ventricular
Ejection Fraction and exercise capacity in patients with angioplasty.
Secondary Objective: To evaluate the effects of arm crank exercises on hemodynamic
parameters (heart rate and blood pressure)
Design
Randomized Controlled Trial
Settings and conduct
Cheema Hospital Gujranwala
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients having planned angioplasty
Both male and female patients
Post extubation
Signed written informed consent
Age 40-60years(15)
Exclusion Criteria:
PCI to nonnative vessel
Implantation of >3 stents
Evidence of thrombus
Presence of infection
Ejection fraction <30%(16)
Intervention groups
Group A: Patients will be treated by standard angioplasty medical protocol.
Group B: Patients will be treated by using arm ergometer.
Main outcome variables
Dyspnea
Left Ventricular Ejection Fraction
Exercise capacity
Hemodynamic
parameters (heart rate and blood pressure)
General information
Reason for update
Acronym
Effects of arm crank exercises in patients with angioplasty.
IRCT registration information
IRCT registration number:IRCT20191117045462N15
Registration date:2024-07-19, 1403/04/29
Registration timing:prospective
Last update:2024-07-19, 1403/04/29
Update count:0
Registration date
2024-07-19, 1403/04/29
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
2024-08-15, 1403/05/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
2024-08-15, 1403/05/25
Actual recruitment end date
2024-12-15, 1403/09/25
Trial completion date
2025-02-15, 1403/11/27
Scientific title
Effects of arm crank exercises on Dyspnea, Left Ventricular Ejection Fraction and exercise capacity in patients with angioplasty.
Public title
Effects of arm crank exercises on Dyspnea, Left Ventricular Ejection Fraction and exercise capacity in patients with angioplasty.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having planned angioplasty
Both male and female patients
Post extubation
Signed written informed consent
Age 40-60years
Exclusion criteria:
PCI to nonnative vessel
Implantation of >3 stents
Evidence of thrombus
Presence of infection
Ejection fraction <30%(16)
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 Group A and 2 for Group B
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patient and assessor physiotherapist will be blinded. Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He or She must have 2- or 3-year experience in relevant domain. He will access the patient by study defined outcome measure tools before the start and at the end of study.
Placebo
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
2024-07-04, 1403/04/14
Ethics committee reference number
RCS&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
Angioplasty
ICD-10 code
Z98.6
ICD-10 code description
Angioplasty status
Primary outcomes
1
Description
Dyspnea
Timepoint
pre and post
Method of measurement
Borg Scale
2
Description
Left Ventricular Ejection Fraction
Timepoint
pre and post
Method of measurement
Echocardiography
3
Description
Exercise capacity
Timepoint
pre and post
Method of measurement
Duke Activity Status Index
Secondary outcomes
1
Description
Hemodynamic parameters
Timepoint
pre and post
Method of measurement
Heart Rate and Blood Pressure
Intervention groups
1
Description
Control group: Standard angioplasty medical protocol.
Category
Rehabilitation
2
Description
Intervention group: Arm ergometer
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cheema Hospital Gujranwala
Full name of responsible person
Zainab Butt
Street address
Zia ul Haq Rd, Civil Lines, Gujranwala
City
Gujranwala
Postal code
55250
Phone
+92 55 3255959
Email
Zianabbutt805@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Phone
+92 42 111 747 424
Email
Wajeeha.zia@riphah.edu.pk
Grant name
Nill
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
15
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
Expert Consultant Clinic
Full name of responsible person
Muhammad Umer Arshad
Position
HOD
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
627, Khayaban e Jinnah, Iqbal Avenue Cooperative Housing Society-Phase 1, Airline Society
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
Zainabbutt805@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
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 42 111 747 424
Email
Wajeeha.zia@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Zainab Butt
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 42 111 747 424
Email
Zinabbutt805@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
Undecided - It is not yet known if there will be a plan to make this available