NCT06407453

Brief Summary

The aim of our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

May 6, 2024

Last Update Submit

October 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Arm Shoulder and Hand Problems Questionnaire

    It is a questionnaire developed by the American Academy of Orthopedic Surgeons (AAOS) based on the World Health Organization (WHO) model and used to evaluate upper extremity function status. The survey consists of three parts, and for all questions in the scale, the person marks the answer that suits him or her on a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all). According to the results of the Arm Shoulder and Hand Problems Questionnaire survey; A result between 0-100 is obtained from each section (0: no problem, 100: maximum problem).

    14 weeks

  • Nordic Musculoskeletal Survey

    It consists of 11 questions asked as a reference from 9 body regions shown on a visual body diagram of neck, shoulder, back, elbow, hand, wrist, waist, hip, thigh, knee, foot, ankle, and corresponds to 99 data items. The questionnaire primarily questions the presence of pain in 9 body regions. If the person's answer is yes, he moves on to the relevant sub-questions.It is a selection scale rather than a rating.

    14 weeks

  • Pittsburgh Sleep Quality Index

    The scale is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleeping Medication Use, and Daytime Dysfunction. Each component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. A total score greater than 5 indicates "poor sleep quality".

    14 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

No intervention will be made

Other: control

exercise

EXPERIMENTAL

exercise program will be applied

Other: exercise

Interventions

controlOTHER

There will be no interference ergonomics training

control

upper extremity strengthening exercises upper extremity stretching exercises ergonomics training posture training relaxation exercises

exercise

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 25-45.
  • Having been a tea craftsman for at least 10 years.
  • Having the ability to read and write Turkish.
  • Agreeing to participate in the study voluntarily.

You may not qualify if:

  • Being diagnosed with a serious psychological illness.
  • Malignancy
  • Advanced osteoporosis
  • Being under 25 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar Üniversity

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Bhattacharyya N, Chakrabarti D. Ergonomic basket design to reduce cumulative trauma disorders in tea leaf plucking operation. Work. 2012;41 Suppl 1:1234-8. doi: 10.3233/WOR-2012-0308-1234.

    PMID: 22316888BACKGROUND
  • Mirbod SM, Fujita S, Miyashita K, Inaba R, Iwata H. Some aspects of occupational safety and health in green tea workers. Ind Health. 1995;33(3):101-17. doi: 10.2486/indhealth.33.101.

    PMID: 8543474BACKGROUND
  • Lallukka T, Hiilamo A, Oakman J, Manty M, Pietilainen O, Rahkonen O, Kouvonen A, Halonen JI. Recurrent pain and work disability: a record linkage study. Int Arch Occup Environ Health. 2020 May;93(4):421-432. doi: 10.1007/s00420-019-01494-5. Epub 2019 Nov 28.

    PMID: 31781902BACKGROUND
  • Marak TR, Bhagat D, Borah S. Musculoskeletal Disorders of Garo Women Workers Engaged in Tea-Plucking Activity: An Ergonomic Analysis. Indian J Occup Environ Med. 2020 May-Aug;24(2):60-65. doi: 10.4103/ijoem.IJOEM_185_19. Epub 2020 Aug 19.

    PMID: 33281373BACKGROUND
  • Kairi TK, Dey S. Prevalence of work-related musculoskeletal symptoms among tea garden workers in Bangladesh: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e061305. doi: 10.1136/bmjopen-2022-061305.

    PMID: 35534079BACKGROUND
  • Gur I, Sevgin O, Dikmen Hosbas B. Effectiveness of ergonomics training and exercise in tea workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Dec;98(9-10):945-955. doi: 10.1007/s00420-025-02185-0. Epub 2025 Nov 18.

MeSH Terms

Conditions

Neck PainBack Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İlayda GÜR

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 9, 2024

Primary Completion

October 15, 2024

Study Completion

October 25, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations