UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057169 |
|---|---|
| Receipt number | R000065355 |
| Scientific Title | Efficacy of an Exercise Program for Improving Physical Pain and Movement: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/02/28 14:34:46 |
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Basic information
Public title
Effects of Exercise Programs on Improving Physical Pain and Movement: A Randomized Controlled Trial
Acronym
PAMEX Trial
Scientific Title
Efficacy of an Exercise Program for Improving Physical Pain and Movement: A Randomized Controlled Trial
Scientific Title:Acronym
PAMEX Trial
Region
| Japan |
Condition
Condition
Non-disabled person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the effects of an exercise program combining stretching and light-load exercises on improving physical movement and pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures, which include pain indicators (WOMAC, RDQ, VAS, and pain items from Locomo 25), will be compared between the intervention and control groups at 3 months post-intervention. Analysis of covariance (ANCOVA) will be used to adjust for baseline values and potential confounding factors, taking into account variables such as age and gender.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Other |
Interventions/Control_1
The intervention group will participate in stretching and light-load exercise interventions conducted by Curves Japan staff three times a week for three months.
Interventions/Control_2
The control group will receive health-related lectures without practical exercises once or twice a month for three months. For ethical considerations, the control group will be offered the same program as the intervention group after the study period, but this data will not be included in the analysis
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Aged 65 years or older
(2) Able to walk independently (capable of visiting Curves locations)
(3) Experiencing mild to moderate pain in the knees or lower back (VAS score less than 7)
(4) Capable of making autonomous decisions
(5) Open to all genders
Key exclusion criteria
(1) Unable to walk independently
(2) Experiencing severe joint pain (VAS score of 8 or higher)
(3) Those with other conditions such as neurological or respiratory diseases, who have been advised by their primary physician to discontinue participation
(4) Individuals with cognitive impairment, altered consciousness, or other conditions that impair their ability to make autonomous decisions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Amari |
| Middle name | |
| Last name | Takashi |
Organization
Saitama Medical University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
350-0496
Address
981 Kawakado, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492951001
amari@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Amari |
| Middle name | |
| Last name | Takashi |
Organization
Saitama Medical University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
350-0496
Address
981 Kawakado, Muroyama-cho, Iruma-gun, Saitama, Japan
TEL
0492951001
Homepage URL
amari@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Amari Takashi
Funding Source
Organization
CURVES Japan Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38, Oaza Murohongo, Muroyama-cho, Iruma-gun, Saitama, Japan
Tel
0492951001
amari@saitama-med.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
埼玉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065355
