Protocol summary

Study aim
The survey of fatigue tolerance in carpet weaving The survey of work-related stress in carpet weavers The survey of prevalence of musculoskeletal disorders in carpet weaving Investigating the effect of workplace physical activity at fatigue tolerance in carpet weaving Investigating the effect of workplace physical activity on the stress caused by work in carpet weaving The effect of workplace physical activity on musculoskeletal disorders in carpet weaving
Design
The present study is a phase 3 of randomized controlled trial parallel group with parallel groups. In this study 100 carpet weavers with musculoskeletal problems will be selected through screening in Shahruod city and the countryside. The participants are randomly assigned into two groups of workplace physical activity group and the control group.
Settings and conduct
After the participants have been identified, informed consent form and a demographic profile questionnaire will be completed by participants. Then baseline evaluations are performed and the participants are randomly assigned into two groups of 50 workplace physical activity group and 50 control group. After classification, the workplace physical activity group participates in an on-site physical activity program for 24 weeks, each days of week for 20 minutes at an intermediate interval of work, and control group subjects continue to their routinely daily activities. At the end of 24 weeks post-test assessments will be similar to the baseline evaluations. Because of the nature of the study, participants are not blinded to allocation, but statisticians and evaluators were blinded from participant’s allocation in groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: physician confirmation for participation in the physical activity program; Ensuring health for participation in exercise training based on the PARQ; Lack of any neurological, severe respiratory, vascular, metabolic and skeletal diseases; Taking tranquilizers, or any special medication that affects the mental state. Exclusion criteria: History of depression, anxiety or other mental disorders; severe problems in the lower and upper extremities or the spine (fracture, cancer, deformity, progressive arthritis); history of joint replacement; lack of regular participation in exercise training programs; and receiving the recent physiotherapy program during the study period.
Intervention groups
The work place physical activity program includes 5 stretching exercises and 9 strengthening exercises that are selected based on previous studies. Specific training programs for each person according to his problems is designed. Stretching exercises were included the muscles of the wrists, elbow, shoulders, and thighs, starting with three 15-second repetitions, and extending over the course of the research to 6 repetitions of 30 seconds. The strengthening exercises were also included to the muscles of the wrists, elbow, and shoulders, and thighs, which are positional isometric and isotonic, and begin with three 15-second repetitions, and during the course of the research, there are 6 repetitions of 30 seconds. Each training session starts with 5 to 10 minutes of exercise and slow stretching for warming. The rest intervals between sets and exercises are 15 and 30 seconds respectively.
Main outcome variables
Musculoskeletal disorders were assessed using Nordic musculoskeletal questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170114031942N2
Registration date: 2018-01-22, 1396/11/02
Registration timing: prospective

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a workplace physical exercise intervention on the fatigue, work-related stress, and musculoskeletal disorders in the hand-woven carpet weavers
Public title
Workplace physical exercise intervention for hand-woven carpet weavers
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 19 to 50 years Musculoskeletal problems caused by weaving carpet
Exclusion criteria:
Age
From 19 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to research groups, a computerized list of random numbers is created using a computer software by one of the research colleagues. Then, one of the members of the research team who is not associated with the participants, divides them into the experimental (training) and control groups using block randomized with blocks 2 and 4. Assignment sequences are hidden by the envelopes encoded in the order numbered, and the envelopes are opened only after all participants basic evaluations have been completed. Because of the nature of the study, participants are not blinded by allocation, but researchers, statisticians and evaluators were blinded from subjects allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Semnan Province, Shahroud, shahroud medical university
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.SHMU.REC.1396.149

Health conditions studied

1

Description of health condition studied
Musculoskeletal Disorders
ICD-10 code
M96
ICD-10 code description
Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Primary outcomes

1

Description
Musculoskeletal disorders
Timepoint
Musculoskeletal disorders in the baseline of the study (before intervention), 24 weeks after initiation of workplace physical activity and after 6 weeks follow up.
Method of measurement
using Nordic musculoskeletal questionnaire.

Secondary outcomes

1

Description
Fatigue symptoms
Timepoint
Was measured in the baseline of the study (before intervention), 24 weeks after initiation of workplace physical activity and after 6 weeks follow up.
Method of measurement
using the Need for Recovery Scale (Br-NFR).

2

Description
Stress level
Timepoint
Was measured in the baseline of the study (before intervention), 24 weeks after initiation of workplace physical activity and after 6 weeks follow up.
Method of measurement
Perceived stress scale - 10

3

Description
Ability of productivity
Timepoint
Was measured in the baseline of the study (before intervention), 24 weeks after initiation of workplace physical activity and after 6 weeks follow up.
Method of measurement
Work Ability Index

Intervention groups

1

Description
Intervention group: The work place physical activity program includes 5 stretching exercises and 9 strengthening exercises that are selected based on previous studies. Specific training programs for each person according to his problems is designed. Stretching exercises were included the muscles of the wrists, elbow, shoulders, and thighs, starting with three 15-second repetitions, and extending over the course of the research to 6 repetitions of 30 seconds. The strengthening exercises were also included to the muscles of the wrists, elbow, and shoulders, and thighs, which are positional isometric and isotonic, and begin with three 15-second repetitions, and during the course of the research, there are 6 repetitions of 30 seconds. Each training session starts with 5 to 10 minutes of exercise and slow stretching for warming. The rest intervals between sets and exercises are 15 and 30 seconds respectively.
Category
Prevention

2

Description
Control group: Continuing the of routinely daily living activities
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
شهرستان شاهرود و حومه
Full name of responsible person
Aynollah Naderi
Street address
Shahrood University of Technology, Tehran Road
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
محمد حسین ابراهیمی
Street address
Semnan Province, Shahroud, shahroud medical university
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
ebrahimi_mh@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
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
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical education and sport science
Street address
Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 917 721 7462
Fax
Email
ay.naderi@shahroodut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 917 721 7462
Fax
Email
ay.naderi@shahroodut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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