UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051011 |
|---|---|
| Receipt number | R000058152 |
| Scientific Title | Management effects of a workplace physical exercise intervention on the fatigue, work-related stress, and musculoskeletal disorders in the hand-woven carpet Weavers |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2023/05/09 03:41:05 |
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Basic information
Public title
The effect of a physical exercise intervention on handwoven carpet weavers
Acronym
The effect of a physical exercise intervention on handwoven carpet weavers
Scientific Title
Management effects of a workplace physical exercise intervention on the fatigue, work-related stress, and musculoskeletal disorders in the hand-woven carpet Weavers
Scientific Title:Acronym
Management effects of a workplace physical exercise intervention on the fatigue, work-related stress, and musculoskeletal disorders in the hand-woven carpet Weavers
Region
| Asia(except Japan) |
Condition
Condition
Musculoskeletal disorders
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of a physical exercise intervention at the workplace on fatigue, work stress, and musculoskeletal disorders in handwoven carpet weavers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Musculoskeletal disorder
Work-related stress
Work-related vitality
Workability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The workplace physical activity program includes 5 stretching exercises and 9 strengthening exercises that are selected based on previous studies.
Interventions/Control_2
They continued their usual activities
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
physician confirmation to participate in the exercise program
Readiness to participate in an exercise program based on PARQ (all questions answered "no")
lack of any neurological, respiratory, vascular, or metabolic disorders
Key exclusion criteria
History of depression, anxiety, or other mental disorders (Mini-Mental State Exam (MMSE< 24)
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
Receiving the recent physiotherapy program during the study period.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sports science
Zip code
3619995161
Address
Shahrood University of Technology, Shahroud, Semnan Province, Iran
TEL
982332392204
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sports science
Zip code
3619995161
Address
Shahrood University of Technology, Shahroud, Semnan Province, Iran
TEL
982332392204
Homepage URL
Ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahroud University of Medical Sciences
Address
Haft Tir Square, Shahrood University of Technology
Tel
989380064684
ay.naderi@yahoo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058152
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
