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Fatigue and Recovery-related Changes in Postural and Core Stability, Back and Hamstring Muscle Strength, and Spine Mobility in Sedentary Adults

Protocol summary

Study aim
To investigate (1) the effect of trunk muscles fatigue on postural and core stability, back and hamstring muscle strength, and spine mobility in sedentary adults, and (2) their changes after recovery modalities including the trunk stabilization exercises, foam rolling exercises, and diaphragmatic breathing exercises.
Design
A clinical trial with a control group, with 3 parallel groups, randomized (simple method), will be conducted on 160 subjects.
Settings and conduct
Each participant will take part in two phases including familiarization and data collection. In the first phase, all participants will undergo a familiarization session and become familiar with the standard test and techniques. In the second phase, data will be collected under three conditions: No fatigue, Fatigue, Recovery The present study will be performed at the Medical University of Kerman, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria Sedentary middle-aged adults at risk of developing non-specific low back pain. Exclusion criteria Pregnancy; history of spinal, femoral, or intra-abdominal surgery in the previous 12 months; receiving physiotherapy services 1 month before the beginning of the study; having suffered any kind of mental health disorder during the past 3 years.
Intervention groups
A: Trunk Stabilization Exercises, B: Foam Rolling Exercises, C: Breathing Exercises, D: Passive Recovery.
Main outcome variables
Help to restore postural and core stability; core, and hamstring muscle strength, and spine mobility in sedentary adults; Help to reduce trunk muscles fatigue and consequently lessen any potential of subsequent injuries in sedentary adults.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221126056606N1
Registration date: 2022-12-25, 1401/10/04
Registration timing: retrospective

Last update: 2022-12-25, 1401/10/04
Update count: 0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
Banafsheh Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 279 3857
Email address
amirib1392@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fatigue and Recovery-related Changes in Postural and Core Stability, Back and Hamstring Muscle Strength, and Spine Mobility in Sedentary Adults
Public title
The effect of 3 different recovery modalities on fatigue induced by prolonged sitting in sedentary adults
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The sedentary middle-aged adults (aged 25 to 44 years), At risk of developing non-specific low back pain, Self-reporting sitting for at least two hours on any working day.
Exclusion criteria:
Pregnancy; History of spinal, femoral, or intra-abdominal surgery in the previous 12 months; Participants having been diagnosed with a congenital anomaly of the spine, arthritis, rheumatoid, infection of the spine and discs, spondylolisthesis, ankylosing spondylitis, spondylosis, tumor, systemic lupus erythematosus, or osteoporosis; Receiving physiotherapy services 1 month before the beginning of the study; Having suffered any kind of mental health disorder, including anxiety and depression, during the past 3 years.
Age
From 25 years old to 44 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization, Permuted block randomization: For randomization, the ‘proc plan’ procedure in the SAS software (ver. 9.1; SAS Institute, Cary, NC, USA) will be used. Using a block randomization method, 160 subjects will be divided randomly into 4 groups in a 1:1:1:1 ratio (block size, 4).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a cross-sectional study to model the process of fatigue and recovery-related changes in postural and core stability, back and hamstring muscle strength, and spine mobility in sedentary middle-age adults at risk of low back pain.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of medical sciences
Street address
Deputy of Research, Kerman University of medical sciences, Somayeh Cross way, Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.386

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Postural stability
Timepoint
Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up.
Method of measurement
FiTRO Sway Check (FiTRONiC, Bratislava, Slovakia)

2

Description
Core stability
Timepoint
Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up.
Method of measurement
Gyko inertial sensor system (Microgate, Bolzano, Italy)

3

Description
Maximal isometric back extensor muscle strength
Timepoint
Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up.
Method of measurement
FiTRO Back Dynamometer (FiTRONiC, Bratislava, Slovakia)

4

Description
Maximal isometric hamstring muscles strength
Timepoint
Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up.
Method of measurement
FiTRO Back Dynamometer (FiTRONiC, Bratislava, Slovakia)

5

Description
Spine mobility
Timepoint
Pre-fatigue, post-fatigue, post-recovery modalities, and follow-up.
Method of measurement
Spinal Mouse device (Idiag, Volkerswill, Switzerland)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Trunk Stability Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.
Category
Prevention

2

Description
Second intervention group: Foam Rolling Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.
Category
Prevention

3

Description
Third Intervention group: Diaphragmatic Breathing Exercises will be applied as an active recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.
Category
Prevention

4

Description
Control group: Lying on the bed will be applied as a passive recovery after the fatigue protocol in order to investigate its effect on the recovery of the studied factors.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Science
Full name of responsible person
Banafsheh Amiri
Street address
The beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
3555 691 761
Phone
+98 913 979 3857
Email
amirib1392@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malek Pourafshar
Street address
Deputy of Research, Kerman University of medical sciences, Somayeh Cross way, Kerman
City
Kerman
Province
Kerman
Postal code
3555 691 761
Phone
+98 34 3226 3719
Email
src@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
SK
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Banafsheh Amiri
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
No. 8, Komeyl Ave., Jomhoori Blvd., Kerman,
City
Kerman
Province
Kerman
Postal code
4133 889 761
Phone
+98 34 3212 5469
Email
amirib1392@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Banafsheh Amiri
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
No. 8, Komeyl Ave., Jomhoori Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
4133 889 761
Phone
+98 34 3212 5469
Email
amirib1392@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Banafsheh Amiri
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
No. 8, Komeyl Ave., Jomhoori Blvd., Kerman,
City
Kerman
Province
Kerman
Postal code
4133 889 761
Phone
+98 34 3212 5469
Email
amirib1392@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
Just that part of the data that includes the main results of the work can be shared, which means that the data related to the personal characteristics of the participants will not be shared.
When the data will become available and for how long
April 2024 onward
To whom data/document is available
Scientific researcher
Under which criteria data/document could be used
In case of request for cooperation to perform comparative analysis or validation.
From where data/document is obtainable
Banafsheh Amiri amirib1392@gnail.com
What processes are involved for a request to access data/document
I will send data after receiving a request email as soon as possible.
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