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The effect of eight weeks Outdoor and Home-Based Pilates Training on sirtuin1, Chemokine CC ligand 20, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis

Protocol summary

Study aim
The main purpose of this study was to evaluate the effect of eight weeks of Pilates training at home and outdoors on Sirtuin , Chemokine CC ligand 20, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis.
Design
Clinical trial with control group, with parallel groups, double-blind, phase 2 on 44 patients. Excel software rand function will be used for randomization.
Settings and conduct
First, 44 people will selected from all women with multiple sclerosis in Fasa. They will then be divided into three groups. The written consent will be received from the subjects based on their voluntary and conscious participation in the training sessions. Before starting the training, two or three sessions of introduction, information about the benefits and possible side effects, as well as how to participate for patients and the required factors (height, weight, BMI, etc.) are measured. Anthropometric characteristics of . Also, cardiorespiratory endurance, muscular endurance, balance and flexibility, endurance, stress, anxiety and sleep quality, as well as blood indicators including sirt1, ccl20 And serum vitamin D will be measured before and after eight weeks of fasting exercise. The place of blood sampling and analysis of the results of Fasa Medical Sciences Laboratory will be.
Participants/Inclusion and exclusion criteria
No smoking, no regular exercise and at least two years of history of the Cardiac and respiratory disease
Intervention groups
In this study, subjects will divided into three groups: Pilates training at home (15 people), Pilates training outdoors (15 people) and control group (14 people).
Main outcome variables
Sirtuin1 Serum Chemokine CC ligand 20 Serum Serum Vitamin D

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220316054315N1
Registration date: 2022-03-29, 1401/01/09
Registration timing: prospective

Last update: 2022-03-29, 1401/01/09
Update count: 0
Registration date
2022-03-29, 1401/01/09
Registrant information
Name
halimeh vahdatpoor
Name of organization / entity
Hakim sabavari
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 2592
Email address
hvahdatpoor.114@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-07-16, 1401/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks Outdoor and Home-Based Pilates Training on sirtuin1, Chemokine CC ligand 20, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis
Public title
The effect Pilates Training on multiple sclerosis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria included no smoking, no regular exercise at least two years of history
Exclusion criteria:
Muscle injuries, inability to perform exercise severe recurrence of the disease participation in a training program other than the training protocol of research pregnancy recurrence of MS in the last 12 weeks change in MS medication or steroid treatment in 12 weeks Past and period of practice non-cooperation until the end of the research process severe recurrence of the disease
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar Hakim University Code of Ethics Committee
Street address
Tohid Town, University Street
City
Sabzavar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.HSU.REC.1400.019

Health conditions studied

1

Description of health condition studied
Patients with MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Physical function based on 6 minutes walking time
Timepoint
Periods of this study before the intervention and 2 days after the intervention
Method of measurement
Measurement of physical function (cardiorespiratory endurance) by 6-minute walking test

2

Description
Investigation of inflammatory status
Timepoint
Measurement of serum cysteine 1 and chemokine 20
Method of measurement
Before intervention and 2 days after intervention

3

Description
Check serum vitamin D status
Timepoint
Before intervention and 2 days after intervention
Method of measurement
Examination of blood serum vitamin D by the kit

Secondary outcomes

1

Description
Assess stress and anxiety
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
By means of the DASS-21 Stress-Anxiety Questionnaire

2

Description
Evaluation of resilience
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
By Connor-Davidson Resilience Questionnaire

3

Description
Evaluation of sleep quality
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
By Sleep Quality Questionnaire

Intervention groups

1

Description
Intervention group1: Pilates Exercise Group Outdoors Intervention.15 people will perform an exercise program for eight weeks (three sessions per hour).
Category
Diagnosis

2

Description
Intervention group2: group. Pilates practice at home. 15 people will perform an exercise program for eight weeks (three sessions per hour).
Category
Diagnosis

3

Description
Control group: 14 people will participate in the study for eight weeks and will not run any exercise program.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Fasa Neuroscience Center
Full name of responsible person
Dr. Kaveh Kashani
Street address
Tohid Town, University Street
City
Sabzavar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2765
Email
vahdatpoor.114@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
dr roya askari
Street address
Tohid Town, University Street
City
sabzavar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2765
Email
vahdatpoor.114@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This research work does not have a sponsor or sponsor.
Proportion provided by this source
100
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
the Hakim Sabzevari University
Full name of responsible person
dr roya askari
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Tohid Town, University Street
City
sabzavar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2763
Email
vahdatpoor.114@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
the Hakim Sabzevari University
Full name of responsible person
halimeh vahdatpoor
Position
PhD student in sports physiology
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Tohid Town, Hakim Sabzevari University
City
sabzavar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2763
Email
hvahdatpoor.114@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
the university of hakim sabevari
Full name of responsible person
halimeh vahdarpoor
Position
PhD student in sports physiology
Latest degree
Ph.D.
Other areas of specialty/work
sports physiology
Street address
no.8, west.Tohid Town, University Street
City
sabavar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2763
Email
hvahdatpoor.114@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 more 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
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