Protocol summary

Study aim
Effects of Yoga vs. Pilates Training on PRL and Cortisol Serum Levels, as well as physical and psychological indicators in females with MS
Design
Study 1: Fifteen participants in this study will be volunteers from the MS Center that will randomly be separated into three groups: yoga group (n=5), Pilates group (n=5), and control group (n=5). The intervention groups will engage in 4-week yoga and Pilates exercises, while the control group will maintain their current lifestyle, without doing any regular physical activity or exercise. Study 2: Forty-eight voluntary (48) patients fulfilling the inclusion criteria mentioned in study one will be randomized the three same groups, Yoga (n=16), Pilates (n =16), and control (n =16) group). .
Settings and conduct
Participants in this study will be volunteers from the MS Center .The intervention will be for 4 weeks in the first study and 8 weeks in the main study of yoga and Pilates exercises and the control group without exercise.
Participants/Inclusion and exclusion criteria
inclusion criteria: EDSS (0-5.5), BMI (range 20-32), and age (range 18-65) and exclusion criteria: Lack of physical exercise, no relapse of the disease in the previous three months, no pregnancy, no history of cardiovascular, metabolic, emotional, cancer, or orthopedic disorders were among the inclusion requirements. Relapse of illness and failure to function were also grounds for exclusion. For the last three months prior to the start of the study, the participants would not have relapses involving the use of corticosteroid medications or cortisone injections
Intervention groups
Three yoga group (n=5), Pilates group (n=5), and control group (n=5) in a pilot study and 48 that will randomize to the three same groups, Yoga (n=16), Pilates (n =16), and control (n =16) group) in the main study.
Main outcome variables
PRL and cortisol level, QOL, IPAQ, Beck, GHQ12,25ft walking test

General information

Reason for update
Acronym
patients with MS= pwMS
IRCT registration information
IRCT registration number: IRCT20211122053145N1
Registration date: 2022-02-08, 1400/11/19
Registration timing: prospective

Last update: 2022-02-08, 1400/11/19
Update count: 0
Registration date
2022-02-08, 1400/11/19
Registrant information
Name
Maryam Poursadeghfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3484 5794
Email address
poursadra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate of the impact Yoga and Pilates Training on Serum Prolactin and Cortisol, Selected Psychological, and Physical Indicators in Female Patients with Multiple Sclerosis
Public title
The effect of exercise on biochemical, psychological, and physical factors of women with MS
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
with inclusion criteria including EDSS (0-5.5), BMI (range 20-32), and age(range 18-65)
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
participants in this study will be volunteers from the MS Center that will randomly be separated into three groups: yoga group (n=21), Pilates group (n=21), and control group (n=21). The randomization sequence will be generated using a computer-generated list of random numbers to create a series of sequentially numbered envelopes containing equal assignments to Pilates and yoga, and waitlist. Recruited participants will be enrolled and assigned a three-digit number in chronological order by a person not involved in the study. Participants will then be randomized to one of the three groups by blocking the stratified sampling method according to age and EDSS.
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 Shiraz University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.SUMS.MED.REC.1400.586

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
prolactin
Timepoint
before and after intervention
Method of measurement
blood sampeling

2

Description
cortisol
Timepoint
before and after intervention
Method of measurement
blood sampling

Secondary outcomes

1

Description
Score of MS QOL questioner
Timepoint
Before and after intervention
Method of measurement
Questioner

2

Description
Score of IPAQ questioners
Timepoint
Before and after intervention
Method of measurement
Questioner

3

Description
Score of Beck depression questioner
Timepoint
Before and after intervention
Method of measurement
Questioner

4

Description
Score of GHQ
Timepoint
Before and after intervention
Method of measurement
Questioner

5

Description
25ft walking test
Timepoint
Before and after intervention
Method of measurement
Timer

Intervention groups

1

Description
Intervention group: yoga exercise
Category
Rehabilitation

2

Description
Intervention group: Pilates exercise
Category
Rehabilitation

3

Description
Control group: they will not regular exercise or physical activity
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadeghfard
Street address
Shiraz University of Medical Sciences,in front of Palestine St,Zand St, Shiraz
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://www.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
مریم پورصادق فر
Street address
zand Blvd,Shiraz,Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://president.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
maryam poursadegh far
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Zand Blvd ,Shiraz, Fars Province, IRAN
City
shiraz
Province
Fars
Postal code
71348-14326
Phone
+98713230541
Fax
Email
info@sums.ac.ir
Web page address
https://president.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
مریم پورصادق فر
Position
associate professer
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Zand Blvd,Shiraz ,IRAN
City
shiraz
Province
Fars
Postal code
71348-14326
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://president.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
maryam pour sadeghfar
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Zand Blvd, Shiraz, IRAN
City
shiraz
Province
Fars
Postal code
71348-14326
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://president.sums.ac.ir

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 plan to publish
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...