To compare the effect of massed vs. distributed lower body strength training on whole body function in elderly women
Design
Clinical trial with a control group, with parallel groups, single-blind, block randomization, on 45 participants.
Settings and conduct
This is a Quasi-experimental study with a pertest-posttest design. Upper and lower body strength tests via digital dynamo-meter, body composition via Akren BIA101 BIVA, gait performance via optogate device and blood pressure and resting heart rate via digital sphygmomanometer will be measured in the laboratory of Bojnourd University. Several functional tests will be used to determine the function movement performance of the participants. Single-blinding will be achieved in such a way that no information will be provided to the participants on which training group they will be placed in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having no regular training over the past six months, healthy women 55 years old and / or older; Exclusion criteria: Having joint and physiological problems, having a history of falling.
Intervention groups
45 healthy, but inactive elderly women will be divided into three groups: Distributed training group (15 people) who will train five times a week, massed training group (15 people) who will train three times a week, the training includes a strength training program, and the control group (15 people) who will not do any exercise training.
Main outcome variables
Upper and lower body muscle strength, functional whole body
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201030049193N3
Registration date:2021-07-03, 1400/04/12
Registration timing:prospective
Last update:2021-07-03, 1400/04/12
Update count:0
Registration date
2021-07-03, 1400/04/12
Registrant information
Name
Mahdi Hosseinzadeh
Name of organization / entity
Sport Sciences Research Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 7714 6478
Email address
metti@ssrc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of massed vs. distributed lower body strength training on whole body function in elderly women
Public title
Effect of massed vs. distributed lower body strength training on whole body function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
women who are 55 years old and/or older
Having no regular training over the past six months
Exclusion criteria:
Having a history of falling
Having joint and physiological problems
Age
From 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Three groups of female participants will be randomly recruited to participate in this study. The block randomization method will be used to create a random sequence to assign participants randomly in one of the three groups. In this method, blocks of 6 all possible combinations (8 modes) are created, then these blocks are numbered and randomly selected and placed one after the other, and thus, participants will be assigned into two groups A and B ( as intervention), and group C (as control).
Blinding (investigator's opinion)
Single blinded
Blinding description
In order for single blinding, some general information about how to perform the training and testing methods will be given to all the participants. However no information will be provided to the participants on which training group they will be placed in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Reseatch Institute
Street address
No. 3,Fifth, Mir Emad St.,Ostad Motahari St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.SSRC.REC.1399.014
Health conditions studied
1
Description of health condition studied
Distributed and massed strength training of the lower body, whole body function (lower and upper body)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lower body strength performance evaluated by hamstring and quadriceps muscles strength.
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Digital dynamo-meter device made in Iran, 30 second chair stand test
2
Description
Strength of the upper body limbs, Biceps muscles
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Digital dynamo-meter device made in Iran, 30 second arm Curl Test
3
Description
Proprioception of the Knee joint, and elbow joint
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Plastic goniometer with accuracy of measuring at least 1 degree
4
Description
Functional Gait Assessment
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Optogait recording with a frequency of 1000 Hz and an accuracy of 1 cm Made in Italy, 10 m walking test
5
Description
Pain score
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Visual Analogue Scale, Timed 10-stair climbing and descending
6
Description
Blood pressure
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Digital Sphygmomanometer
7
Description
Anthropometric indices
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Weight measurement using a digital scale made in China with an accuracy of 100 grams. Measuring the circumference of the arm, forearm, thigh, leg using a tape meter made in Iran with an accuracy of 0.1 cm. Body composition recorded using the BIA101 BIVA Akren made in Italy
8
Description
Resting heart rate
Timepoint
The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve.
Method of measurement
Digital Sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Consisting of 15 participants who will be training using a distributed strength program, including 5 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), 10-minute of general stretching movements. Strength training of lower limbs (part II), The program in the first month of training will be based on the individual's weight, the second month with low resistance stretch bands, the third month with medium and high resistance stretch bands. A cool down (part III), consisting of 10 minutes walking, standing and sitting stretching movements will finally be completed.
Category
Rehabilitation
2
Description
Intervention group 2: Consisting of 15 participants will be training in a massed strength training protocol. The protocol includes 3 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), including 10-minute stretching movements. Strength training of the lower body limbs (part II), The first month training will be implemented based on the individual's weight, the second month with low resistance stretch bands, the third month with medium and high resistance stretch bands. A cooling down (part III) program, including 10 minutes walking, standing and sitting stretching movements will finally be completed.
Category
Rehabilitation
3
Description
Control group: Consisting of a group of 15 participants who will continue to their regular daily living but will attend to the three sessions of pre, mid, and post test sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Univercity of Bojnord
Full name of responsible person
Mahta Sardroodian
Street address
4th Km along the Road to Esfarayen, Bojnord, North
City
Bojnord
Province
North Khorasan
Postal code
9453155111
Phone
+98 58 3220 1000
Fax
+98 58 3228 4605
Email
Info@ub.ac.ir
Web page address
https://ub.ac.ir/en/home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Univercity of Bojnord
Full name of responsible person
Hasan Sajjadi
Street address
4th Km along the Road to Esfarayen, Bojnord, North Khorasan
City
Bojnord
Province
North Khorasan
Postal code
9453155111
Phone
+98 58 3220 1000
Fax
+98 58 3228 4605
Email
Info@ub.ac.ir
Web page address
https://ub.ac.ir/en/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
We share data files including personal information and data related to pre-test and post-test in a coded and unanimous folder by the person in charge, Dr. Mehdi Hosseinzadeh, on the website of Bojnord University.
When the data will become available and for how long
Start the access period as soon as the results are published
To whom data/document is available
It will be available to all research groups as well as all other people who are interested
Under which criteria data/document could be used
The data can be used for further studies as well as in all research groups, and any kind of research analysis and use is allowed on the data, and under the conditions that the person use it should refer to us (the paper published), this data will be provided to them.
From where data/document is obtainable
Refer to the person responsible for answering Dr. Mehdi Hosseinzadeh: Address: No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran, Iran Sport Science Researcher Institute Postal Code 1587958711 Email: metti@ssrc.ac.ir Phone: 009877146478 : 00988739092
What processes are involved for a request to access data/document
The applicant will send his/her application to the e-mail address of Dr. Mehdi Hosseinzadeh (metti@ssrc.ac.ir) and Dr. Hosseinzadeh will provide the information to his/her after the necessary checks