UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062084 |
|---|---|
| Receipt number | R000071029 |
| Scientific Title | Effects of Different Exercise Doses (4 and 8 kcal/kg body weight/week) on Body Weight, JKOM, and Skeletal Muscle Mass Index in Overweight Female Patients with Knee Osteoarthritis: A Three-Arm Randomized Controlled Trial Examining Dose-Response Relationships |
| Date of disclosure of the study information | 2026/06/28 |
| Last modified on | 2026/06/28 14:59:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Different Exercise Doses on Body Weight and Patient-Reported Outcomes in Overweight Female Patients with Knee Osteoarthritis: Evaluation of Dose-Response Relationships Using a Randomized Controlled Trial
Acronym
KOA-DOSE
Scientific Title
Effects of Different Exercise Doses (4 and 8 kcal/kg body weight/week) on Body Weight, JKOM, and Skeletal Muscle Mass Index in Overweight Female Patients with Knee Osteoarthritis: A Three-Arm Randomized Controlled Trial Examining Dose-Response Relationships
Scientific Title:Acronym
KOA-DOSE
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of different exercise doses (physical therapy alone, physical therapy plus 4 kcal/kg body weight/week, and physical therapy plus 8 kcal/kg body weight/week) on body weight, the Japanese Knee Osteoarthritis Measure (JKOM), and skeletal muscle mass index (SMI) in overweight female patients with knee osteoarthritis, and to identify the optimal exercise dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight (kg): measured using a body composition analyzer (InBody270) at baseline (week 0), week 4, week 8, and week 12
Key secondary outcomes
Japanese Knee Osteoarthritis Measure (JKOM) and Skeletal Muscle Mass Index (SMI): assessed at baseline, week 4, week 8, and week 12
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standardized physical therapy only: range of motion exercises for hip and knee joints, strengthening exercises mainly for quadriceps and hip abductors, balance training, basic movement training, and activities of daily living training, twice weekly for 12 weeks.
Interventions/Control_2
Standard physical therapy plus cycle ergometer exercise at 4 kcal/kg body weight/week. Exercise dose was gradually increased from 1 kcal/kg/week by 1 kcal/kg/week per week, reaching 4 kcal/kg/week at week 4 and maintained thereafter. Twice weekly for 12 weeks.
Interventions/Control_3
Standard physical therapy plus cycle ergometer exercise at 8 kcal/kg body weight/week. Exercise dose was gradually increased from 1 kcal/kg/week by 1 kcal/kg/week per week, reaching 8 kcal/kg/week at week 8 and maintained thereafter. Twice weekly for 12 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
Female, aged 50 years or older, medial knee osteoarthritis, BMI 24 kg/m2 or higher, Kellgren-Lawrence classification Grade 2 or 3
Key exclusion criteria
Lateral knee osteoarthritis, history of total hip or knee arthroplasty, history of myocardial infarction, angina, or arrhythmia, rheumatoid arthritis, history of knee fracture or malignancy, difficulty walking independently, dementia, history of central nervous system disease, or severe illness precluding exercise participation
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Tamari |
Organization
Teikyo Heisei University
Division name
Department of Physical Therapy, Faculty of Health and Medical Science
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
123M13301@edu.thu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Oka |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences, Department of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
Homepage URL
123M13301@edu.thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
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
Teikyo Heisei University Institutional Review Board
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo 170-8445, Japan
Tel
03-5843-3111
123M13301@edu.thu.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 | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 28 | Day |
Last modified on
| 2026 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071029
