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The effect of eight weeks Home-Based and Outdoor Pilates Training on Neurofilament light chain, Kynurenine pathway, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis

Protocol summary

Study aim
Determining the effect of home-based (HPT) and outdoor (OPT) Pilates training on 1. Improvement of Neurofilament Light Chain 2- Improvement of the Kynurenine pathway 3- Improvement of vitamin D 4- Improvement of physical function 5- Improvement of mental function In women with MS
Design
A clinical trial with the control group, with parallel groups, double-blind, phase 2 on 44 patients. Excel software rand function was used for randomization.
Settings and conduct
First, 44 people selected from all women with multiple sclerosis in Fasa and divided into three groups. The written consent was 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, agility and muscle strength, and fatigue, quality of life and depression, as well as blood indicators including Nfl, Kynp And serum vitamin D were measured before and after eight weeks of fasting exercise. The place of blood sampling and analysis of the results were Fasa Medical Sciences Laboratory.
Participants/Inclusion and exclusion criteria
Admission requirements include no smoking, no regular exerciseو at least two years of history Exclusion criteria include muscle injuries, severe recurrence of the disease, inability to perform the exercise
Intervention groups
Intervention group 1: 8 weeks of home-based and outdoor Pilates training (3 sessions per week, 1hour each session) Control group: did not do any regular exercise for eight weeks and remained sedentary.
Main outcome variables
Neurofilament light chain, Kynurenine pathway, serum Vitamin D, functional ability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220324054348N1
Registration date: 2022-05-09, 1401/02/19
Registration timing: retrospective

Last update: 2022-05-09, 1401/02/19
Update count: 0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Faranak Balaghi Inaloo
Name of organization / entity
The University of Hakim Sabzevari
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2755
Email address
f.balaghi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
2022-02-04, 1400/11/15
Actual recruitment end date
2022-04-09, 1401/01/20
Trial completion date
2022-04-09, 1401/01/20
Scientific title
The effect of eight weeks Home-Based and Outdoor Pilates Training on Neurofilament light chain, Kynurenine pathway, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis
Public title
The effect of Pilates exercise on the treatment of multiple sclerosis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
at least two years of history EDSS between 2 and 5 no smoking, no regular exercise
Exclusion criteria:
Muscle injuries Severe relapse of the disease disability to perform sports exercises Lack of regular participation in the training protocol Participate in a training program other than the research training protocol, Pregnancy relapse of MS in the last 12 weeks Change in MS medication or steroid treatment in the last 12 weeks and period of practice Lack of cooperation until the end of the research process
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
Actual sample size reached: 34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Among the reasons for this study is the role of home-based exercise in preventing the risk of Covid 19 in sports venues, the benefits of Pilates training and its ability to perform and adjust its intensity at home, its low cost and popularity among these patients, and its impact on improving the condition. Functional and psychological of these patients and, most importantly, considering the role of sunlight in the absorption of vitamin D and its effect on disease severity and modulation of psychological factors, it is not yet clear whether exercise through the kynurenine pathway or through other mediators can affect the results. Whether it has a psychological effect or not (Lim et al., 2021). Therefore, according to studies conducted so far, no research has been observed on the effect of Pilates exercise at home and outdoors on the structural proteins of neurons and important molecular pathways in the progression of the disease and psychological and physical factors in patients with MS. Therefore, this study is the first study to compare the effect of 8 weeks of Pilates training at home and outdoors on NFL indices, kynurenine pathway (KYN, TRP, KA, QA), serum vitamin D, and some psychological factors (fatigue, depression, quality of life). And physical function (coordination, balance, abdominal muscle endurance, gait endurance, and upper and lower body muscle strength) of women with MS.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Hakim Sabzevari University
Street address
Tohid Town
City
sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.HSU.REC.1400.015

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Blood serum vitamin D status
Timepoint
48 hours before and 48 hours after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA) by the Kit

2

Description
the inflammatory status of axonal damage (Neurofilament light chain)
Timepoint
2 days before the intervention and 2 days after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA) by the Kit

3

Description
Status of neuroprotective metabolites in the kynurenine pathway (kynurenine and kynurenic acid)
Timepoint
48 hours before and 48 hours after the intervention
Method of measurement
Liquid chromatography–mass spectrometry (LC–MS)

4

Description
Status of neurodegenerative metabolite in the kynurenine pathway (quinolinic acid)
Timepoint
48 hours before and 48 hours after the intervention
Method of measurement
Liquid chromatography–mass spectrometry (LC–MS)

Secondary outcomes

1

Description
Assess fatigue status
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
By the Fatigue Severity Scale (FSS) Questionnaire

2

Description
Evaluation of Quality of life
Timepoint
48 hours before and 48 hours after the study
Method of measurement
By multiple sclerosis Quality of life-54 (MSQOL-54) Questionnaire

3

Description
evaluation of deppresion
Timepoint
48 hours before and 48 hours after the study
Method of measurement
questionnaires Depression, Anxiety, Stress Scales (DASS-21)

4

Description
Physical function based on 6 minutes walking time
Timepoint
48 hours before and 48 hours after the study
Method of measurement
Measurement of physical function (cardiorespiratory endurance) by 6-minute walking test

Intervention groups

1

Description
Intervention group1: Pilates Exercise Group Outdoors Intervention.15 people performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively.
Category
Diagnosis

2

Description
Intervention group2: group. Pilates practice at home. 15 people performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively.
Category
Diagnosis

3

Description
Control group: 14 people participated in the study for eight weeks and did 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
NO 612, Bargh street, Kheybar Alley
City
Darab
Province
Fars
Postal code
9617976487
Phone
+98 51 4401 2765
Email
Kave57m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Hakim Sabzevari
Full name of responsible person
Dr. Roya Askari
Street address
NO 612, Bargh street, Kheybar Alley
City
Darab
Province
Fars
Postal code
9617976487
Phone
+98 51 4441 0104
Email
r.askari@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Hakim Sabzevari
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University Of Hakim Sabzevari
Full name of responsible person
Dr Roya askari
Position
Assosiate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
NO 612 Bargh street, Kheybar Alley
City
Darab
Province
Fars
Postal code
9617976487
Phone
+98 51 4401 2763
Email
r.askari@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Hakim Sabzevari
Full name of responsible person
Faranak Balaghi Inaloo
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
NO 612 Bargh street, Kheybar Alley
City
Darab
Province
Fars
Postal code
9617976487
Phone
+98 71 5352 4843
Email
faranakbalaghi70@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Hakim Sabzevari
Full name of responsible person
Faranak Balaghi Inaloo
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
NO 612 Bargh street, Kheybar Alley
City
Darab
Province
Fars
Postal code
9617976487
Phone
+98 51 4401 2763
Email
faranakbalaghi70@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
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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