UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062074 |
|---|---|
| Receipt number | R000071026 |
| Scientific Title | Effects of Comfortable Self-Paced Exercise on the Cognitive and Affective Functions of Pain |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/26 20:09:38 |
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Basic information
Public title
Effects of Comfortable Self-Paced Exercise on the Cognitive and Affective Functions of Pain
Acronym
Comfortable Self-Paced Exercise and Pain Cognition/Affect Study
Scientific Title
Effects of Comfortable Self-Paced Exercise on the Cognitive and Affective Functions of Pain
Scientific Title:Acronym
CSPE-PainCAF Study
Region
| Japan |
Condition
Condition
Rotator cuff injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of comfortable self-paced aerobic exercise on cognitive and affective aspects of pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total score of the Pain Catastrophizing Scale from 1 to 16 weeks postoperatively
Key secondary outcomes
Change in the total score of the Patient Health Questionnaire-9
Assessment time points: 1, 2, 4, 8, 12, and 16 weeks postoperatively
Change in pain intensity measured using an 11-point Numerical Rating Scale
Assessment time points: 1, 2, 4, 8, 12, and 16 weeks postoperatively
Change in shoulder range of motion
Assessment time points: 1, 2, 4, 8, 12, and 16 weeks postoperatively
Change in upper limb function assessed using the Shoulder36
Assessment time points: preoperatively and 8, 12, and 16 weeks postoperatively
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to usual postoperative rehabilitation, participants perform comfortable self-paced aerobic exercise using a cycle ergometer for 15 minutes, twice daily, at least 6 days per week, starting 1 week postoperatively.
Interventions/Control_2
Participants receive usual postoperative rehabilitation only and do not perform comfortable self-paced aerobic exercise using a cycle ergometer.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with a rotator cuff tear and have undergone arthroscopic rotator cuff repair.
Key exclusion criteria
A history of psychiatric disorders.
Inability to complete questionnaires due to dementia.
Inability to provide informed consent for participation in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
0864641109
kfmbs599@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
0864641109
Homepage URL
kfmbs599@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Hirata Junya
Funding Source
Organization
Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kurashiki Heisei Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasaoka Daiichi Hospital
Address
1945 Yokoshima, Kasaoka, Okayama
Tel
08656702111
kfmbs599@mw.kawasaki-m.ac.jp
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
| 2026 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
41
Results
At 1 week postoperatively, no measured variable differed significantly between groups (p > .05). Pain decreased significantly at 4 and 8 weeks in controls (p < .05). In the intervention group, pain and PCS-rumination decreased at 4 and 8 weeks, and PHQ-depression decreased at 8 weeks, compared with 1 week (p < .05).
Results date posted
| 2026 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-one patients who underwent arthroscopic rotator cuff repair for rotator cuff injury and were prescribed rehabilitation participated in this study. All participants were judged by their attending physicians to be able to perform aerobic exercise.
Participant flow
The intervention group performed aerobic exercise in addition to usual rehabilitation starting 1 week postoperatively, with permission from the attending physician. The exercise consisted of aerobic exercise using a cycle ergometer at an intensity that each participant perceived as comfortable. Each session lasted 15 minutes and was performed once in the morning and once in the afternoon. The exercise was performed at least 5 days per week and continued until hospital discharge. The control group received usual rehabilitation.
Adverse events
No adverse events were observed in this study.
Outcome measures
Pain intensity measured using the Numerical Rating Scale, pain catastrophizing measured using the Pain Catastrophizing Scale, and depressive symptoms measured using the Patient Health Questionnaire-depression were assessed at 1, 4, and 8 weeks postoperatively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071026
