The effect of combined training (resistance - endurance) and red Grape juice supplementation on Daily Memory, Retrospective Memory, Prospective Memory and Quality of life of patients with Multiple sclerosis
Determining the effect of 8 weeks of combined training (resistance _ endurance) at home with red grape juice supplementation on daily, retrospective and prospective memory in patients with multiple sclerosis.
Design
The clinical trial with control group, with factorial groups, without blinding, simple randomized, phase zero and on 56 patients in 4 groups of practice, supplement, exercise + supplement and control with simple randomization is performed.
Settings and conduct
This research will be conducted in the field of rehabilitation and support in Kermanshah city and on women with MS aged 40-40 years. 56 patients are divided into 4 groups of exercise, supplement, exercise + supplement and control according to the expert diagnosis and without blindness. After grouping, each member of the group will find the desired questionnaires and will receive them after the answer. The groups will do the training and supplement protocol for 8 weeks and 3 sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Multiple sclerosis, age 20 to 40 years, less than 4.5 degrees, not participating in regular exercise. Exclusion criteria: pregnancy, illness, physical weakness
Intervention groups
Exercise group: Exercise for 8 weeks and 3 times a week for 1 hour a day, exercise includes 10 minutes of warm-up, 45 minutes of the main body of the exercise and 5 minutes of cooling. Complementary group: for 8 weeks and a week Consume 250 cc of red grape juice 3 times as a snack between morning and noon. Supplement group + Exercise: Grape juice and exercise for 8 weeks and 3 times a week Control group: Perform daily activities for 8 weeks Week.
Main outcome variables
Memory, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211020052826N1
Registration date:2022-03-13, 1400/12/22
Registration timing:registered_while_recruiting
Last update:2022-03-13, 1400/12/22
Update count:0
Registration date
2022-03-13, 1400/12/22
Registrant information
Name
Amin Jalili sarqaleh
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 38 3443 4263
Email address
aminjs0409@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2023-02-23, 1401/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined training (resistance - endurance) and red Grape juice supplementation on Daily Memory, Retrospective Memory, Prospective Memory and Quality of life of patients with Multiple sclerosis
Public title
The effect of exercise and grape juice on multiple sclerosis(Ms)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multiple sclerosis with less than ten years of history
The degree of Disease is less than 4.5
Ages 20 to 40 years
Not participating in regular sports activities
No regular use of red grape juice one month before the study
Exclusion criteria:
Being pregnant
Cardiovascular problems
Inability to exercise
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this design, a simple targeted randomization will be used as an individual choice for each group. 4 containers will be used to place the balls and a sealed envelope will be used for the names of the individuals. An unrelated person is used for concealment and takes the names of the people out of the envelope and puts them in each of the containers. 12 people will be placed in each container and the names inside the 4 containers will be considered as research groups. Each container is considered as one of the 4 groups and each container represents one of the groups that the unrelated person puts 48 balls which includes the names of the statistical community in each container. . 12 balls are placed in each container, respectively, so that all the containers reach 12 balls, and then the names are taken out of the containers and considered as a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Memory score in the Sunderland et al. Questionnaire
Timepoint
Memory is measured before the start of the study and after the end of the study (2 Munt).
Method of measurement
Sunderland Memory Questionnaire
2
Description
Quality of life score in the World Health Organization questionnaire
Timepoint
Before the start of the study and immediately after the end of the study (2 months)
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The training group performs warm-ups for 10 weeks and 3 sessions per week for 10 minutes, 45 minutes of main training and 5 minutes of cooling. The exercises will be aerobic and resistance. Aerobic exercise will include 20 minutes of walking based on the individual's ability. The 45-minute resistance training will include movements such as launching forward, getting up from the chair, and folding the back of the leg. 10 minutes of warm-up training before training and 5 minutes of cooling after training.
Category
Rehabilitation
2
Description
Intervention group 2: The supplement group will consume 250 cc of red grape juice with a concentration of 68%, which is provided naturally, for 8 weeks and 3 sessions per week between morning and noon.
Category
Rehabilitation
3
Description
Intervention group 3: Exercise group + supplement for 8 weeks and 3 sessions per week will use combined exercises for 10 minutes of warm-up, 45 minutes of main training and 5 minutes of cooling with 250 cc of red grape juice with a concentration of 68%
Category
Rehabilitation
4
Description
Control group: continues its daily activities for 8 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah MS Association Center
Full name of responsible person
Amin Jalili Sarqaleh
Street address
No. 3, Alley 5, Azadegan St., Lordegan,
City
Lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8899134678
Phone
+98 38 3443 4263
Email
aminjs0409@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr. Mohammad Azizi
Street address
Kermanshah, Bostan Arch, Daneshgah St., Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
info@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Razi University of Kermanshah
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amin Jalili Sarqaleh
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 3,Alley 5, Azadegan St.,
City
lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
9913467888
Phone
+98 38 3443 4263
Email
aminjs0409@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amin Jalili Sarqaleh
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No20. Alley 5,Azadegan St.,
City
Lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8819994561
Phone
+98 38 3443 4263
Email
aminjs0409@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amin Jalili Sarqaleh
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 20,Alley 5, Azadegan St.
City
lordegan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8999914561
Phone
+98 38 3443 4263
Email
aminjs0409@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