Evaluate the effect of high-intensity interval training combined with L-Citrulline supplementation on CAF, balance and muscular performance in elderly men with Sarcopenia
Design
Clinical trial with a control group, with parallel groups, Single blind, randomized. The sample size is 10 people in each group. the randomization will be done using a random numbers table.
Settings and conduct
In this study, 40 elderly men bearing Sarcopenia were randomly selected and in a randomized single-blind design, will allocate into four groups of 10 subjects including training, supplementation, training+supplementation and control. High-intensity interval training performed for 8 weeks, 3 days a week. The supplement and control groups consumes 6 grams of L-citrulline and placebo per main meal. Samples are collected two day before the protocol is executed and 72 hours after the last training session. Concentration of serum CAF, muscle mass, muscle strength and walking speed are measured.
The participants will not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 60-75
Having general physical and mental health
Suffering from sarcopenia
Man
Exclusion criteria:
Having a history of chronic disease
Inability to exercise
Having regular exercise history (3 times a week, more than 30 minutes)
Drug use or supplementation
Intervention groups
1. Exercise group : Three sessions of exercise per week for 6 weeks with placebo
2. Supplements group: Take 6 grams of L-citrulline daily
3. Supplement and Exercise Group: 6 grams of L-citrulline supplement per day and three sessions of exercise per week for 8 weeks
4. Control group: no exercise and supplement and with placebo
Effects of high-Intensity interval training combined with L-Citrulline supplementation on neuromuscular indices in elderly men with Sarcopenia
Public title
Effects of high-intensity interval training and L-Citrulline supplementation on neuromuscular indices in elders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 60-75
Having general physical and mental health
Suffering from sarcopenia
Man
Exclusion criteria:
Having a history of chronic disease
Inability to exercise
Having regular exercise history (3 times a week, more than 30 minutes)
Drug use or supplementation
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the subjects will be selected using a simple random method. Then, using a table of random numbers, they are divided into four groups. Therefore, each candidate will be assigned a two-digit number. Equal to the sample size, the same number of digits is determined for the selection of individuals (five-digit numbers whose last two digits are similar to the existing codes) that are randomly assigned to one of the groups It will be given. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the option to change the status of the assignment or predict it. Random hiding will be done by a third party who does not participate in other stages of the intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will be randomly allocated in to 4 groups and will not aware of the type of treatment. For this purpose, we informed each subject in the form of a confidential letter about all the tasks and their grouping requirements. We reported the status of the subject grouping through the code selected for each group and no group names were recorded in the subjects' letters.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- Sari branch
Street address
Department of Exercise Physiology, Islamic Azad University of Sari, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
۱۴۷۷۸۹۳۷۸۰
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.IAU.SARI.REC.1401.032
Health conditions studied
1
Description of health condition studied
Sarcopenia
ICD-10 code
M62.5
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified
Primary outcomes
1
Description
Serum C-terminal agrin fragment peptide
Timepoint
Before and after eight weeks of intervention
Method of measurement
ELISA commercial kit
Secondary outcomes
1
Description
Balance
Timepoint
Before and after eight weeks of intervention
Method of measurement
Romberg test
2
Description
Muscular strength
Timepoint
Before and after eight weeks of intervention
Method of measurement
Dynamometer
3
Description
Functional ability
Timepoint
Before and after eight weeks of intervention
Method of measurement
Timed up and go test
Intervention groups
1
Description
Intervention group: Exercise+Placebo: high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, This group received one capsule similar (placebo) to supplement L-citrulline for 8 weeks.
Category
Placebo
2
Description
Intervention group: Supplement group: L-citrulline supplement consumed in single 6 g-dose daily for 8 weeks.
Category
Other
3
Description
Intervention group: Exercise+supplement group: participants of this group performed high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, this group received L-citrulline supplement in single 6 g-dose daily for 8 weeks.
Category
Other
4
Description
Control group: This group received one capsule (placebo) similar to supplement L-citrulline for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Sari
Full name of responsible person
Amin Farzaneh Hesari
Street address
Department of Exercise Physiology, Sari Branch, Islamic Azad University, Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
af.hessari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sadegh Salmanpor
Street address
Office of Research and Technology, Sari Islamic Azad University, Farah absd road
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
sadeghsalmanpour@gmail.com
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
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
Islamic Azad University
Full name of responsible person
Amin Farzaneh Hesari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Department of Exercise Physiology, Sari Branch, Islamic Azad University, Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
af.hessari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amin Farzaneh Hesari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Department of exercise physiology, Sari Branch, Islamic Azad University, Farah abad road
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
af.hessari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amin Farzaneh Hesari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Department of exercise physiology, Sari Branch, Islamic Azad University, Farah abad road
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
af.hessari@gmail.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A piece of data that contains information about variables that can be shared.
When the data will become available and for how long
Available period from 2022
To whom data/document is available
Researchers
Under which criteria data/document could be used
Statistical analysis on the data is not allowed.
From where data/document is obtainable
Amin Farzaneh Hesari
af.hessari@gmail.com
What processes are involved for a request to access data/document
The purposes and uses of the data should be clearly stated by the applicant.