UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059543 |
|---|---|
| Receipt number | R000068110 |
| Scientific Title | The Effect of Eight Weeks of Knee-Specific and Whole-Body Aquatic Exercise on Strength, Balance, and Knee Proprioception in People with Knee Osteoarthritis |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/27 04:25:16 |
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Basic information
Public title
The Effect of Eight Weeks of Knee-Specific and Whole-Body Aquatic Exercise on Strength, Balance, and Knee Proprioception in People with Knee Osteoarthritis
Acronym
The Effect of Aquatic Exercise on Strength, Balance, and Knee Proprioception in People with Knee Osteoarthritis
Scientific Title
The Effect of Eight Weeks of Knee-Specific and Whole-Body Aquatic Exercise on Strength, Balance, and Knee Proprioception in People with Knee Osteoarthritis
Scientific Title:Acronym
The Effect of Aquatic Exercise on Strength, Balance, and Knee Proprioception in People with Knee Osteoarthritis
Region
| Asia(except Japan) |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To survey the effect of aquatic exercise on performance
Basic objectives2
Others
Basic objectives -Others
1. To survey the effect of aquatic exercise on performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To survey the effect of aquatic exercise on performance
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
3
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
| 45 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1- A score of at least 39 on the WOMAC questionnaire (Bellamy, 2008), 2- Age between 45 and 60 years, 3- Ability to perform exercises in water, 4- No joint injection or surgery in the past 6 months, 5- No use of oral anti-inflammatory drugs in the past 1 week (before starting the exercise protocol)
Key exclusion criteria
The exclusion criteria were: 1- fear of water, 2- excessive absence (absence of 2 consecutive sessions and 3 non-consecutive sessions), and 3- unwillingness to continue participating in the study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Seyed Hossein |
| Middle name | |
| Last name | Hosseinimehr |
Organization
University of Kurdistan
Division name
Department of Physical Education and Sport Sciences
Zip code
6617715175
Address
pasdaran
TEL
989173034237
s.h.hosseinimehr@uok.ac.ir
Public contact
Name of contact person
| 1st name | Seyed Hossein |
| Middle name | |
| Last name | Hosseinimehr |
Organization
University of Kurdistan
Division name
Department of Physical Education and Sport Sciences
Zip code
6617715175
Address
pasdaran
TEL
989173034237
Homepage URL
s.h.hosseinimehr@uok.ac.ir
Sponsor or person
Institute
University of Kurdistan
Institute
Department
Personal name
Funding Source
Organization
University of Kurdistan
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
University of Kurdistan
Address
pasdaran
Tel
989173034237
s.h.hosseinimehr@uok.ac.ir
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 | 10 | Month | 27 | Day |
Related information
URL releasing protocol
ok
Publication of results
Unpublished
Result
URL related to results and publications
https://research.uok.ac.ir/~hosseinimehr/
Number of participants that the trial has enrolled
45
Results
The results indicated that both experimental groups (whole-body and knee-specific) demonstrated significant improvements in all dependent variables, including muscle strength, static balance, dynamic balance, and proprioception, after the hydrotherapy period (p<0.001).
Results date posted
| 2025 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The results indicated that both experimental groups (whole-body and knee-specific) demonstrated significant improvements in all dependent variables, including muscle strength, static balance, dynamic balance, and proprioception, after the hydrotherapy period (p<0.001).
Participant flow
Screening stage
At this stage, participants were selected based on inclusion and exclusion criteria and completed the WOMAC questionnaire to diagnose KOA. Anthropometric characteristics (such as age, height, mass, and body mass index) were recorded.
Pre-tests
In the pre-test, strength, balance (static and dynamic), and knee proprioception were measured and the results were recorded.
Exercise protocols
Participants in the experimental groups participated in a total of 24 training sessions (three times a week for two months). The training process was designed based on the principle of overload.
Tests during the training protocol
During the training period, the subjects underwent the same pre-test tests again after 4 weeks, and the results were recorded and analyzed.
Post-tests
Also, at the end of the training period, the subjects were again subjected to the same pre-test tests, and the results were recorded and analyzed.
Adverse events
fear of water
Outcome measures
Isometric strength of the quadriceps, hamstrings, hip adductors, hip abductors, dorsiflexors, and plantar flexors was measured using a Manual Muscle Tester according to validated protocols. Before the start of the assessment, subjects completed a familiarization session with the test procedure and a five-minute general warm-up to reduce learning effects and risk of injury. Each effort was performed in isometric conditions with three consecutive repetitions, and the average was recorded as the final result.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 05 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068110
