UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055587 |
|---|---|
| Receipt number | R000063524 |
| Scientific Title | Investigation the Comparative Effects of the Exercise Program in two different depths of the water pool and land on physical, physiological and psychological factors on people suffering from arthritis |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/07/13 18:49:30 |
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Basic information
Public title
Dr.Zamanian
Acronym
Dr. Zamanian
Scientific Title
Investigation the Comparative Effects of the Exercise Program in two different depths of the water pool and land on physical, physiological and psychological factors on people suffering from arthritis
Scientific Title:Acronym
Investigation the Comparative Effects of the Exercise Program in two different depths of the water pool and land on physical, physiological and psychological factors onarthritis
Region
| Asia(except Japan) |
Condition
Condition
finished
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of water exercise in two different depths of water and on land on static and dynamic Balance, muscle strength, flexibility, range of motion, falling risk, quality of life, mobility in patients with chronic knee Osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all variables in shallow and deep-water exercise and land exercise groups improved significantly compared to the control group. However, the improvement of these variables in the water exercise groups were significantly more than the land exercise group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
shallow-water exercise group
Interventions/Control_2
deep-water exercise group
Interventions/Control_3
land exercise
Interventions/Control_4
control group
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 55 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
60 patients in the age range of 55 years and above, and at least eight months had passed since the diagnosis of chronic osteoarthritis in their knee joint by a specialist physician
Key exclusion criteria
absence of exercise
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Faezeh |
| Middle name | |
| Last name | Zamanian |
Organization
Iran University of Art
Division name
Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code
1136813518
Address
Iran University of Art, # 56, Sakhai St., Hafez ave., Tehran, Iran
TEL
02166733401
faezezamanian@yahoo.com
Public contact
Name of contact person
| 1st name | Faezeh |
| Middle name | |
| Last name | Zamanian |
Organization
Iran University of Art
Division name
Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code
1136813518
Address
Iran University of Art, # 56, Sakhai St., Hafez ave., Tehran, Iran
TEL
02166733401
Homepage URL
faezezamanian@yahoo.com
Sponsor or person
Institute
Iran University of Art
Institute
Department
Personal name
Funding Source
Organization
Iran University of Art
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
Iran University of Art
Address
Iran University of Art, # 56, Sakhai St., Hafez ave., Tehran, Iran
Tel
02166733401
faezezamanian@yahoo.com
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
| 2025 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063524
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/07/13 | ethical cod-2.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/07/13 | ethical cod-2.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/07/13 | ethical cod-2.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/63524
