Protocol summary

Study aim
Determining the effect of 8 weeks of aerobic and resistance training on serum levels of N-terminal peptide type 3 (P3NP), agrin C fragment (CAF), creatinine to cystatin C ratio, some functional indices (upper and lower body strength, aerobic endurance, balance), some body composition indices (weight, body mass index, fat mass and muscle mass) in elderly women
Design
A quasi-experimental design with a control group, with factorial groups, single-blind, randomized on 36 elderly people, Randomi allocation software will be used for randomization.
Settings and conduct
It will be conducted in the field of exercise physiology in the city of Tabriz, and the participants will be unaware of how the other groups performed.
Participants/Inclusion and exclusion criteria
1. No medication 2. No specific skeletal disease 3. No underlying disease 4. Ability to perform sports 5. Women aged 65 to 75 6. No metabolic disease (diabetes, blood pressure, high cholesterol, etc.) 7. Possibility of sarcopenia (decreased muscle function) 8. No risk factors (chest pain, heart attack in first-degree relatives, limping when walking, etc.)
Intervention groups
The aerobic exercise group will perform simple aerobic activities, walking, jogging and slow running continuously and in the form of 8. The resistance group exercises include movements that involve the main muscle groups. Initially, movements will be performed for 10 to 15 repetitions then will increase to 8 to 12 repetitions. The intensity of the movements will also range from 40 to 50% of 1RM to 60 to 80% of 1RM. The control group will follow the normal course of daily activities.
Main outcome variables
Preventing sarcopenia and dynapenia in the elderly, which ultimately improves life in the elderly and reduces the burden of additional costs and independence of the elderly.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240108060648N2
Registration date: 2025-11-14, 1404/08/23
Registration timing: prospective

Last update: 2025-11-14, 1404/08/23
Update count: 0
Registration date
2025-11-14, 1404/08/23
Registrant information
Name
Fatemeh Baharavar
Name of organization / entity
The univercity of tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 2932
Email address
baharavar.f@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-15, 1404/08/24
Expected recruitment end date
2025-12-15, 1404/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resistance and aerobic exercises training on CAF, CCR and P3NP related with sarcopenia and dynapenia in elderly
Public title
Effect of resistance and aerobic training on dynapenia and sarcopenia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Possibility of doing sports activities The presence of sarcopenia
Exclusion criteria:
Taking medication Having certain musculoskeletal diseases Underlying disease Presence of risk factors (chest pain, heart attack in first-degree relatives, limping when walking, etc.)
Age
From 65 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The study population will be elderly women aged 65 to 75 years in Tabriz city, who will be selected on a convenience and voluntary basis. Then 36 people will be selected and after measuring body composition indices and morphological characteristics, they will be randomly divided into 3 groups control, aerobic and resistance groups using the Random allocation software program. Then the groups will be homogenized in terms of age and then concealment will be done using sealed envelopes to prevent bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
Concealment will be done using sealed envelopes to prevent bias
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Tabriz University of Medical sciences
Street address
Faculty of Physical Education and Sport Sciences, University of Tabriz, Abrassan street
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.TABRIZU.REC.1404.030

Health conditions studied

1

Description of health condition studied
Sarcopenia- Dinapenya
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Creatinine to cystatin C ratio
Timepoint
24 hours before starting the training protocol and 48 hours after its completion
Method of measurement
Creatinine measurement using Pars Azmoun kits Tehran, Iran -Cys-C measurement using ELISA kit (BioVendor, Czech Republic)

2

Description
N-terminal propeptide of procollagen type 3
Timepoint
24 hours before starting the training protocol and 48 hours after its completion
Method of measurement
N-terminal propeptide of procollagen type 3 kit from zellbio, Germany

3

Description
Agrin C-terminal fragment
Timepoint
24 hours before starting the training protocol and 48 hours after its completion
Method of measurement
Agrin C-terminal fragment kit from zellbio, Germany

Secondary outcomes

1

Description
Body composition index
Timepoint
24 hours before the protocol and 48 hours after the protocol is completed
Method of measurement
Digital Arzoom scale for measuring the weight of subjects - German Seka model 769 height scale for measuring the height of tests - Body composition formula

Intervention groups

1

Description
first Intervention group: The aerobic exercise group will perform simple aerobic activities, walking, jogging, and slow running continuously in a figure-8 pattern. The load of walking sessions will gradually increase during the training weeks.
Category
Lifestyle

2

Description
Second Intervention group: Resistance group exercises include movements that involve the main muscle groups. Each session will last about an hour, including 10 minutes of warm-up, 10 minutes of cool-down, and 40 minutes of main exercises. The movements will be performed stationary. In the first sessions, 8 movements will start in two rounds, and gradually the number of movements will increase to 10 movements in three rounds. Initially, movements will be performed for 10 to 15 repetitions, and as the sessions progress, they will reach 8 to 12 repetitions. The intensity of the movements will also range from 40 to 50 percent of 1RM (low intensity) to 60 to 80 percent of 1RM (moderate intensity). The exercises will initially start with low intensity, and then overload will be applied according to the readiness of the subjects.
Category
Lifestyle

3

Description
Control group: The control group will follow their normal daily activities during this period. Subjects will be asked to refrain from exercise 48 hours before blood collection.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
An invitation to cooperate will be posted on social media channels, public and health centers, and t
Full name of responsible person
Baharavar Fatemeh
Street address
Tabriz univercity
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Phone
+98 914 408 0237
Email
baharavar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The univercity of tabriz
Full name of responsible person
Javad Vakili
Street address
Abersan Street, University of Tabriz, Faculty of Physical Education and Sport Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Phone
+98 914 391 3141
Email
vakili.tu@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fatemeh Baharavar
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 univercity of tabriz
Full name of responsible person
Fatemeh Baharavar
Position
Phd student and teacher
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiologist
Street address
No77,babaei2,parvaz,tabriz,iran
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Phone
+98 41 3386 2932
Fax
Email
baharavar.F@tabrizu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The univercity of tabriz
Full name of responsible person
Fatemeh Baharavar
Position
Phd student and teacher
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiologist
Street address
No77,babaei2,parvaz,tabriz,iran
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Phone
+98 41 3386 2932
Fax
Email
baharavar.F@tabrizu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The univercity of tabriz
Full name of responsible person
Fatemeh Baharavar
Position
Phd student and teacher
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiologist
Street address
No77,babaei2,parvaz,tabriz,iran
City
Tabriz
Province
East Azarbaijan
Postal code
5164736931
Phone
+98 41 3386 2932
Fax
Email
baharavar.F@tabrizu.ac.ir

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after being de-identified.
When the data will become available and for how long
Since 1405
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers can use this data
From where data/document is obtainable
Fatemeh Baharavar
What processes are involved for a request to access data/document
By email
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