Protocol summary

Study aim
The timing and recruitment patterns of the lower-limb muscles change in the elderly. The aim of this study was to investigate the effects of Pilates exercises on the balance and co-contraction of selected lower-limb muscles in elderly.
Design
The sample consists of 22 elderly women which are divided into two groups of control (N=10 ) and intervention (N=12 ).
Settings and conduct
All the research steps are done in Shahid Haghir Zavareh Stadium.Subjects who have inclusion criteria get a doctor's approval for exercise. The written informed consent was obtained from all subjects prior to the measurements. Balance tests and the electrical activity of the selected lower-limb muscles before and after the exercises were measured. The experimental group participated in training protocols of Pilates exercise for eight-week.
Participants/Inclusion and exclusion criteria
inclusion criteria were as follows: female range 60–80 years, no regular participation in a regular aerobic exercise program, having a history of a fall in the past year, and having a doctor's approval for exercise. The study exclusion criteria were specified as follows: having a postural disorder based on New York’s criteria, having a history of previous lower limb surgery within the previous year, having a history of specific diseases or other diseases (e.g., neuromuscular disease, osteoarthritis, severe spinal deformity, paralysis, infections, tumors, severe vision or hearing impairment)
Intervention groups
Experimental group performed 8 weeks of the Pilates exercises Control Goup: Common Activity
Main outcome variables
Pilates excercise can effect on Balance؛ Anticipatory and cocontraction of selected lower-limb muscles in elderly.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200613047758N1
Registration date: 2020-07-07, 1399/04/17
Registration timing: retrospective

Last update: 2020-07-07, 1399/04/17
Update count: 0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Najmeh Noghani Ardestani
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 6615 2471
Email address
najmenoghani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-24, 1397/07/02
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-04-03, 1398/01/14
Actual recruitment end date
2019-06-04, 1398/03/14
Trial completion date
2019-06-04, 1398/03/14
Scientific title
The Effects of Pilates Exercises on the Balance and Anticipatory and Co-contraction of Selected Lower-Limb Muscles in the Elderly with a History of Falling
Public title
The Effects of Pilates Exercises on the Balance and Anticipatory on Co-contraction of Selected Lower-Limb Muscles in the Elderly with a History of Falling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female range 60–80 years having no regular participation in a regular exercise program history of a fall in the past year having a doctor's approval for exercise
Exclusion criteria:
having a postural disorder based on New York’s criteria having a history of previous lower limb surgery within the previous year having a history of specific diseases or other diseases (e.g., neuromuscular disease, osteoarthritis, severe spinal deformity, paralysis, infections, tumors, severe vision or hearing impairment)
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 22
Randomization (investigator's opinion)
Not randomized
Randomization description
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
University of social welfare and rehabilitation sciencess.
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.USWR.REC.1397.092

Health conditions studied

1

Description of health condition studied
falling
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Effects of Pilates Exercises on the Balance in the Elderly with a History of Falling
Timepoint
It was measured before the intervention as well as after the intervention(after 8 week)
Method of measurement
Berg Balance Test, Time Up and Go Test

2

Description
The Effects of Pilates Exercises on the Anticipatory Performance of Selected Lower-Limb Muscles in the Elderly with a History of Falling
Timepoint
It was measured before the intervention as well as after the intervention(after 8 week)
Method of measurement
Recording of electrical muscle activity was performed by 16-channel Electromyography device, manufactured by Baya med Iran Company

3

Description
The Effects of Pilates Exercises on Co-contraction of Selected Lower-Limb Muscles in the Elderly with a History of Falling
Timepoint
It was measured before the intervention as well as after the intervention(after 8 week)
Method of measurement
Recording of electrical muscle activity was performed by 16-channel Electromyography device, manufactured by Baya med Iran Company

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Training protocol to novice and intermediate levels is obtained from an updated version of the Brazilian Protocol of Pérez et al. (2014). The first week session was designed to get beginners acquainted with the principles of Pilates, according to the principles of Pilates' technique. Then 7-week was designed to prepare the elderly for performing intermediate level Pilates exercises that elderly can do.
Category
Prevention

2

Description
Control group: A group as a controller who engages in normal activities and does not receive any training protocol
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Haghir Zavareh Jym
Full name of responsible person
Najmeh Noghani Ardestani
Street address
Shohada Ave, Naeen Road
City
Zavareh
Province
Isfehan
Postal code
8441875151
Phone
+98 31 5437 2700
Email
najmenoghani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Jalal Dehghani Firouzabadi
Street address
Bolvar-e-Gharbi-e-Stadium-e-Azadi Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
148743411
Phone
+98 21 4839 4121
Email
Najmenoghani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Najmeh Noghani Ardestani
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
corrective exercise & Sport injury
Street address
Floor 1, No 4, Shabnam Ave, Khanabadi Ave, Mortazavi Street next to the Jeyhoon
City
Tehran
Province
Tehran
Postal code
1354984111
Phone
+98 21 6615 2471
Email
Najmenoghani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Dr. Farideh Babakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercise & Sport injury
Street address
Bolvar-e-Gharbi-e-Stadium-e-Azadi Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4839 4121
Email
Farideh_Babakhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Najmeh Noghani Ardestani
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Others
Street address
Floor 1, No 4, Shabnam Ave, Khanabadi Ave, Mortazavi Street next to the Jeyhoon
City
Tehran
Province
Tehran
Postal code
1354984111
Phone
+98 21 6615 2471
Email
Najmenoghani@yahoo.com

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
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