UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060990 |
|---|---|
| Receipt number | R000069790 |
| Scientific Title | Acute Effects of Self-Paced Aerobic Exercise on Affective Responses in Hospitalized Patients |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/19 13:27:11 |
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Basic information
Public title
Effects of Self-Paced Aerobic Exercise on Mood in Hospitalized Patients
Acronym
SPAE Study
Scientific Title
Acute Effects of Self-Paced Aerobic Exercise on Affective Responses in Hospitalized Patients
Scientific Title:Acronym
SPAE-AR Study
Region
| Japan |
Condition
Condition
Hospitalized patients including those with cerebrovascular and musculoskeletal disorders
Classification by specialty
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the acute effects of self-paced aerobic exercise on affective responses in hospitalized patients with cerebrovascular and musculoskeletal disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in affective responses assessed by the Feeling Scale (FS) (difference between pre-exercise and immediately post-exercise)
Key secondary outcomes
1. Perceived exertion assessed by the Borg Rating of Perceived Exertion (RPE) during and immediately after exercise
2. Time-course changes in affective responses assessed by the Feeling Scale (FS) during exercise
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A single session of self-paced aerobic exercise is performed in hospitalized patients. Exercise is conducted using a cycle ergometer, and participants are allowed to freely adjust the exercise intensity within a comfortable range. The duration of exercise is approximately 10 minutes.
Interventions/Control_2
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
Hospitalized patients with cerebrovascular or musculoskeletal disorders
Patients judged by a physician to be capable of performing aerobic exercise
Patients who provided informed consent after receiving an explanation of the study
Key exclusion criteria
Patients with medical contraindications to aerobic exercise
Patients with severe cognitive impairment who are unable to understand instructions
Patients with severe physical dysfunction that makes assessment difficult
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
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
Department of Occupational Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
kfmbs599@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasaoka Daiichi Hospital
Address
1945 Yokoshima, Kasaoka, Okayama
Tel
0865-67-0211
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 | 03 | Month | 19 | 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
36
Results
Affective responses assessed by the Feeling Scale (FS) significantly improved after self-paced aerobic exercise compared with before exercise. Perceived exertion, assessed by the Borg Rating of Perceived Exertion (RPE), remained within a moderate range during exercise. No adverse events were observed in this study.
Results date posted
| 2026 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 36 hospitalized patients participated in this study. Participants were patients with musculoskeletal or cerebrovascular disorders who were admitted to the departments of orthopedics or neurosurgery. All participants were judged by their attending physicians to be capable of performing aerobic exercise.
Participant flow
Patients admitted to general wards and referred for rehabilitation between September 2012 and March 2013 were screened for eligibility. A total of 36 patients who met the inclusion criteria and provided informed consent were enrolled in the study. All participants completed the self-paced aerobic exercise and were included in the analysis of the primary outcome.
Adverse events
No adverse events were observed in this study.
Outcome measures
The primary outcome was affective responses assessed by the Feeling Scale (FS), which was measured before and immediately after exercise. Secondary outcomes included perceived exertion assessed by the Borg Rating of Perceived Exertion (RPE), which was measured during and immediately after exercise.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 25 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069790
