1. Home
  2. Approved trials
  3. » فارسی

The Effect of Eight Weeks Pilates Exercises on Functional Movement, Pain and Quality of Life in Patients with Spondylolysis

Protocol summary

Study aim
The Effect of Eight Weeks Pilates Exercises on Functional Movement, Pain and Quality of Life in Patients with Spondylolysis
Design
Semi-experimental study with pretest and posttest design on patients with spondylolysis who were randomly selected and randomly divided into intervention and control groups
Settings and conduct
Patients in the intervention group performed Pilates exercises for 8 weeks, 3 weeks each and 60 minutes each session under the supervision of Pilates instructor. Also, for the reliability and assurance of the results of the evaluation of the subjects before and after eight weeks, the research tests The present was performed by a tester at a similar time of the day. Also, the test was unaware of which subject was placed (blind one way).
Participants/Inclusion and exclusion criteria
Individuals with spondylolysis and non-infectious diseases, tumors, rheumatoid diseases, osteoporosis, congenital anomalies of the spine, taking anti-inflammatory and analgesic drugs, were approved by a physician specialist in the neurological and neuropathology of the spine. The exercise program and treatment work outside the current research and the lack of regular participation in regular sessions and absence of more than three sessions in exercise therapy sessions, other therapeutic interventions and reluctance to continue cooperation in the research were criteria for withdrawal from studies..
Intervention groups
Experimental group for eight weeks, three session in a week, and each session 60 minutes performed selected Pilates exercises, but during these time control group did not participate in any treatment activity and performed normal daily activities.
Main outcome variables
Dynamic balance and Static; Muscular Endurance of the Central Part of Body; Range of Motion of Lumbar Spine; Pain; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181218042034N1
Registration date: 2019-02-20, 1397/12/01
Registration timing: retrospective

Last update: 2019-02-20, 1397/12/01
Update count: 0
Registration date
2019-02-20, 1397/12/01
Registrant information
Name
Saeid Jamali Brayjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3684 3508
Email address
n.rahnama@sprt.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
2018-08-23, 1397/06/01
Scientific title
The Effect of Eight Weeks Pilates Exercises on Functional Movement, Pain and Quality of Life in Patients with Spondylolysis
Public title
The Effect of Pilates Exercises in Patients with Spondylolysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with spondylolysis Diagnosis of the spines neuropsychologist diagnosis
Exclusion criteria:
Lack of infection Lack of tumor Lack of rheumatoid patients Lack of Osteoporosis Lack of congenital disorder Do not take anti-inflammation drugs and pain
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method was performed by a third person who did not have any information from the research so that the name and family of each subject were placed in similar envelopes without the content being specified and after the closing of the door the envelopes were requested from the person concerned. Envelope Equities placed in boxes A and B, without the third party's knowledge, Box A, the representative of the intervention group and the B-block control agent.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner has been blinded to the extent to which the subjects (experimental or control) have been blinded to influence the way in which the test and results are conducted, as well as the subjects with full knowledge of the research and completion of the consent form for participation in a study Satisfied
Placebo
Not used
Assignment
Parallel
Other design features
Modality for the rehabilitation of spondylolysis

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Islamic Azad University (Khorasgan)
Street address
University blvd-Arghavaniya-East gay street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.117

Health conditions studied

1

Description of health condition studied
Spondylolysis
ICD-10 code
M43.0
ICD-10 code description
Spondylolysis

Primary outcomes

1

Description
The effect of Pilates exercises on: 1-dynamic balance 2- static balance 3-muscular endurance of the central part of body 4- range of motion of lumbar spine 5- pain 6- quality of life in patients with spondylolysis
Timepoint
Before the intervention and 2 day after eight weeks of intervention
Method of measurement
1. Y test 2. Stork test 3. McGill test 4. Modified_Modifided Schobers technique 5. visual analog scale VAS 6. quality of Life Questionnaire SF-36

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Experimental group for eight weeks, three session in a week, and each session 60 minutes performed selected Pilates exercises
Category
Rehabilitation

2

Description
Control group: During this period (eight weeks), the control group did not participate in any kind of therapeutic activity and engaged in daily activities.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
مطب دکتر
Full name of responsible person
دکتر سعید ابریشم کار
Street address
Chahar Bagh - Shari'ati Street - Facing Shariati Hospital - Faraz Building - First Floor - Unit 103
City
Isfahan
Province
Isfehan
Postal code
8145148916
Phone
+98 31 3233 0091
Email
abrishamkar@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
professor Majid Toghyani
Street address
Isfahan- East Azarbayjan-Arghavaniyeh- University Blvd.
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
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
Iranian academic center for education culture and research
Full name of responsible person
Nader Rahnama
Position
Full Professor, Faculty Member of Isfahan University
Latest degree
Ph.D.
Other areas of specialty/work
sport pathology
Street address
Isfahan, Azadi Square, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2195
Email
Rahnamanader@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Nader Rahnama
Position
Full Professor, Faculty Member of Isfahan University
Latest degree
Ph.D.
Other areas of specialty/work
sport pathology
Street address
Isfahan, Azadi Square, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2195
Email
Rahnamanader@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Nader Rahnama
Position
Full professor of faculty member of Isfahan University (responsible author)
Latest degree
Ph.D.
Other areas of specialty/work
sport pathology
Street address
Isfahan, Azadi Square, Isfahan University
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2195
Email
Rahnamanader@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unnamed participants' data, practice protocols, and data analysis, a form set up to satisfy the company's participation in research without the names of the participants, and the results of the research for other collaborative researchers.
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use for Rehabilitation
From where data/document is obtainable
Email: Saidgamali655@gmail.com
What processes are involved for a request to access data/document
send mail
Comments
Loading...