The purpose of this study is to investigate the effect of 8 Weeks Pilates, Walking, and Combined exercises on Resting Heart Rate and Resting Blood Pressure in Patients with Cardiac Arrhythmia.
Design
A clinical trial with the intervention groups, parallel, randomized, with a predicted sample size of 60 and Phase 3 trial
Settings and conduct
This study will be performed on cardiac arrhythmias patients living in Zahedan, Iran. The duration of the research is 8 weeks and the participants are divided into three groups randomly. One interventional factor (exercise) is considered for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All Patients with Tachycardia Resident in Zahedan
Exclusion criteria: Patients undergoing cardiac surgery Patients undergoing knee surgery Patients undergoing cervical disc surgery Patients undergoing lumbar disc surgery
Intervention groups
First intervention group: Pilates Exercise; Exercise for 8 weeks, 3 sessions per week will be carried out. Pilates exercise has been selected as the intervention of this group.
Second intervention group: Walking exercise; walking activity has been selected as the intervention of this group.
Third intervention group: Combined Exercises; Exercises for 8 weeks, 3 sessions per week will be carried out. In this group, Pilates and Walking exercises are an intervention agent.
Main outcome variables
Study of resting heart rate changes; Study of resting systolic and diastolic blood pressure Changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040073N4
Registration date:2018-12-16, 1397/09/25
Registration timing:registered_while_recruiting
Last update:2018-12-16, 1397/09/25
Update count:0
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
Majid Vahidian-Rezazadeh
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6107
Email address
vahidian@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 8 Weeks Pilates, Walking, and Combined exercises on Resting Heart Rate and Resting Blood Pressure in Patients with Cardiac Arrhythmia
Public title
"Effect of Physical activity on Resting Heart Rate and Resting Blood Pressure in Patients with Cardiac Arrhythmia"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients with Tachycardia Resident in Zahedan
Exclusion criteria:
Patients undergoing cardiac surgery
Patients undergoing knee surgery
Patients undergoing cervical disc surgery
Patients undergoing lumbar disc surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization Tool: Sealed Envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hasabi's Square,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.213
Health conditions studied
1
Description of health condition studied
Cardiac arrhythmia
ICD-10 code
I49.8
ICD-10 code description
Other specified cardiac arrhythmias
Primary outcomes
1
Description
Resting heart rate changes in tachycardia patients
Timepoint
Measurement of resting heart rate at the beginning of the study (pre-intervention) and the end of the fourth and eighth weeks
Method of measurement
Finger pulse oximeter
2
Description
Resting blood pressure changes in tachycardia patients
Timepoint
Measurement of systolic and diastolic blood pressure at the beginning of the study (before the intervention) and the end of the fourth and eighth weeks
Method of measurement
Digital Arm Blood Pressure Monitor
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Pilates Exercise
Category
Treatment - Other
2
Description
Second Intervention group: Walking Exercise
Category
Treatment - Other
3
Description
Third Intervention group: Combined exercises (Pilates and Walking)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Hadi Heidari Mokarrar
Street address
Ali Ebn Abitaleb Hospital, Salamat Blvd., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
hadiheidarimokarrar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dor Mohammad Kordi
Street address
Deputy of Research, Central Organization, University of Sistan and Baluchestan, Daneshgah Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6246
Email
dor_kordi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
Proportion provided by this source
100
Public or private sector
Public
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
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Majid Vahidian-Rezazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 129, Pardisan 1 Ave, University Residential Complex, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744687
Phone
+98 54 3341 6107
Fax
Email
vahidian@ped.usb.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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