UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059283 |
|---|---|
| Receipt number | R000067812 |
| Scientific Title | Effects of Exercise in Hospital Employees with Chronic Pain |
| Date of disclosure of the study information | 2025/10/03 |
| Last modified on | 2025/10/03 19:29:25 |
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Basic information
Public title
A Study on the Effects of an Exercise Program for Hospital Workers with Chronic Pain
Acronym
Exercise and Chronic Pain Study
Scientific Title
Effects of Exercise in Hospital Employees with Chronic Pain
Scientific Title:Acronym
Exercise and Chronic Pain in Hospital Workers
Region
| Japan |
Condition
Condition
Chronic pain (chronic musculoskeletal pain)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic pain is often prolonged by psychological and cognitive factors and is closely linked to occupational stress among workers. The aim of this study is to examine the effects of exercise on chronic pain and occupational stress in hospital employees. Specifically, we will evaluate pain intensity, cognitive appraisal of pain, psychological factors such as anxiety and depression, and occupational stress, in order to clarify the impact of an exercise intervention. The findings of this study are expected to contribute to strategies for supporting mental health in workers with chronic pain and to inform the role of exercise programs in occupational health practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological stress response subscales of the Brief Job Stress Questionnaire (BJSQ)
Key secondary outcomes
1.Pain-related measures
Pain intensity: Visual Analog Scale (VAS)
Pain catastrophizing: Pain Catastrophizing Scale (PCS)
Pain-related disability: Pain Disability Assessment Scale (PDAS)
2.Psychological measures
Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
3.Physical activity and physical function
Physical activity: daily steps and activity time measured by accelerometer
Physical function: flexibility (finger-to-floor distance), grip strength, quadriceps strength (knee extension strength)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 12-week exercise program consisting of 20 minutes of aerobic exercise, resistance training, and stretching, performed twice per week. One session per week is supervised by a physical therapist, and the other is performed independently by participants.
Interventions/Control_2
A 12-week exercise program consisting of 20 minutes of aerobic exercise, resistance training, and stretching, performed twice per week. One session per week is supervised by a physical therapist, and the other is performed independently by participants.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees of a regional core hospital
Individuals with chronic musculoskeletal pain persisting or recurring for over 6 months (CP group), or those without pain in the past 4 weeks (NP group)
No regular exercise habit
Able to continue a 3-month exercise program
Able to complete the self-administered questionnaires
Key exclusion criteria
Having a regular exercise habit
Presence of cardiovascular or circulatory diseases that restrict exercise
History of surgery or currently indicated for surgical treatment
Any other condition judged by the investigator to make the participant unsuitable for this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Sakamoto |
Organization
Health Science University
Division name
Department of Rehabilitation
Zip code
401-0380
Address
7187 Kodachi, Fujikawaguchiko-machi, Minamitsuru-gun, Yamanashi, Japan
TEL
0555835200
y.sakamoto@kenkoudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Sakamoto |
Organization
Health Science University
Division name
Department of Rehabilitation
Zip code
401-0380
Address
7187 Kodachi, Fujikawaguchiko-machi, Minamitsuru-gun, Yamanashi, Japan
TEL
0555835200
Homepage URL
y.sakamoto@kenkoudai.ac.jp
Sponsor or person
Institute
Health Science University
Institute
Department
Personal name
Sakamoto Yuta
Funding Source
Organization
Japan Health Promotion & Fitness Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fuefuki Central Hospital
Address
47-1 Yokkaichiba, Isawa-cho, Fuefuki-shi, Yamanashi, Japan
Tel
055-262-2185
No
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
笛吹中央病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.health-net.or.jp/tyousa/josei/pdf/h28/h28houkoku_sakamoto.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.health-net.or.jp/tyousa/josei/pdf/h28/h28houkoku_sakamoto.pdf
Number of participants that the trial has enrolled
24
Results
In the chronic pain group, baseline pain was 37.3 mm (VAS), disability 11.3 (PDAS), and duration 368 weeks. Rumination improved (p=0.01). Occupational stress improved in vigor (p=0.03), physical complaints (p=0.004), and total response (p=0.02). No significant changes were seen in total PCS, VAS, or PDAS.
Results date posted
| 2025 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 05 | Month | 12 | Day |
Baseline Characteristics
In the chronic pain group (n=12), mean age was 33.5 years, 58% were female, mean pain intensity was 37.3 SD 16.9 mm (VAS), and disability (PDAS) was 11.3 SD 11.4. In the no-pain group (n=9), mean age was 28 years, 56% were female, and VAS was 0.
Participant flow
A total of 24 hospital employees participated in the study, comprising 13 in the chronic pain (CP) group and 11 in the no pain (NP) group. During the intervention, one participant in the CP group and two in the NP group withdrew. Thus, 12 participants in the CP group and 9 in the NP group (total 21) were included in the final analysis.
Adverse events
No adverse events related to the intervention occurred during the study. Three participants withdrew during the intervention period, all due to reasons related to daily life outside the study.
Outcome measures
The mean scores of the primary outcome, psychological stress, decreased over time in the chronic pain group (CP) (T0: 38.6, 1: 36.0, 2: 31.8). In the no-pain group (NP), the values were T0: 40.7, 1: 41.1, and 2: 37.2. Repeated MDSA (repeated-measures distributed sentence analysis) showed a significant change in the NP group (p=0.004), whereas no significant change was observed in the CP group (p=0.50).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was conducted before clinical trial registration, and retrospectively registered.
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067812
