Protocol summary

Summary
The purpose of this study was to determine the effect of 8 weeks resistance training and leucine supplementation on protein synthesis in older men with sarcopenia. In this study, 40 elderly bearing Sarcopenia based on muscle strength of hand less than 26- 30 kg were selected and after explaining the study and obtaining written consent in 4 groups of 10 people including resistance training and supplementation, resistance training, supplementation and control is divided. Resistance training performed for 8 weeks, 3 days a week. Starting the exercise at the first session with a 35% intensity maximum of one maximum repeat (1RM) for 20 minutes and in the final session to 70% of the 1RM for 45 minutes. The supplement and control groups consumes 3 grams of leucine and placebo per main meal. Samples are collected one day before the protocol is executed and 72 hours after the last training session. Concentration of serum insulin, urine nitrogen, muscle mass, muscle strength and walking speed are measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017071034997N1
Registration date: 2017-09-03, 1396/06/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
zahra sadat pormozafari
Name of organization / entity
Bahonar Kerman
Country
Iran (Islamic Republic of)
Phone
+98 32758907
Email address
geochemistry@iauzar.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of resistance training and leucine supplements on protein synthesis in old men bearing Sarcopenia
Public title
Effect of resistance exercise and suppelment leucine on the treatment of Sarcopenia
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria: Male; Aged 60- 65; Having general physical and mental health. Exclusion criteria: Having a history of chronic disease (heart failure, chronic obstructive pulmonary disease, kidney failure, cancer, diabetes, anemia and thyroid disease); Drug use or supplementation (such as corticosteroids and anabolic hormones); Inability to exercise; Having regular exercise history (3 times a week, more than 30 minutes).
Age
From 60 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee kerman university of medical sciences & health services
Street address
Beginning of Ibn Sina street, Beginning of Jihad Boulevard, Four Way Somayeh
City
Kerman
Postal code
Approval date
2017-03-18, 1395/12/28
Ethics committee reference number
IR.kmu.REC.1395.359

Health conditions studied

1

Description of health condition studied
Sarcopenia
ICD-10 code
M62.84
ICD-10 code description
Sarcopenia

Primary outcomes

1

Description
Protein synthesis
Timepoint
Before and 8 weeks after intervention
Method of measurement
Evaluation of nitrogen balance and muscle mass

Secondary outcomes

1

Description
Insulin
Timepoint
Before and after 8 weeks of intervention
Method of measurement
kamilonseans

2

Description
Hand muscle strength
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Manual dynamometer

3

Description
Walking speed
Timepoint
Before and after 8 weeks of intervention
Method of measurement
4 metrs walking speed

Intervention groups

1

Description
The training group 8 weeks and each week 3 sessions of resistance training performed with a duration of 20- 45 minutes and intensity of 35- 70 % one repetition maximum and 48 hours of rest between sessions.
Category
Other

2

Description
The supplement group consumes 3 grams of leucine per meal for 8 weeks and 3 sessions each week.
Category
Other

3

Description
The exercise and supplements group for 8 weeks and each week 3 sessions of resistance training performed with a duration of 20- 45 minutes and intensity of 35- 70 % one repetition maximum and 48 hours of rest between sessions. Also, 3 grams of leucine supplement consumes ratio 1/3, 1 hour before and 3 hours after exercise.
Category
Other

4

Description
The control group consumes 3 grams of placebo per meal for 8 weeks and 3 sessions each week.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center Elderly Amir al-Momenin
Full name of responsible person
Street address
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bahonar University
Full name of responsible person
Dr Maryam Ehtesham Zadeh
Street address
Boulevard 22 Bahman, Kerman
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bahonar University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bahonar University
Full name of responsible person
Dr Mohsen Aminaie
Position
Ph.D. Sports Physiology
Other areas of specialty/work
Street address
Boulevard 22 Bahman, Kerman
City
Kerman
Postal code
Phone
+98 343257624
Fax
Email
maminai@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bahonar University
Full name of responsible person
Dr Rohollah Nikooie
Position
Ph.D. Sport Physiology
Other areas of specialty/work
Street address
Boulevard 22 Bahman, Kerman
City
Kerman
Postal code
Phone
+98 343257624
Fax
Email
r_nikooie@uk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bahonar University
Full name of responsible person
Zahra Sadat Pourmazfari
Position
Other areas of specialty/work
Street address
City
kerman
Postal code
Phone
+98 34 3275 8907
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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