UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048356 |
|---|---|
| Receipt number | R000055110 |
| Scientific Title | An association between central sensitization and autonomic nervous system and an effect of aeobic exercise for patietns with knee and hip osteoarthritis |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/05/01 11:49:21 |
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Basic information
Public title
An association between central sensitization and autonomic nervous system and an effect of aeobic exercise for patietns with knee and hip osteoarthritis
Acronym
An association between central sensitization and autonomic nervous system and an effect of aeobic exercise
Scientific Title
An association between central sensitization and autonomic nervous system and an effect of aeobic exercise for patietns with knee and hip osteoarthritis
Scientific Title:Acronym
An association between central sensitization and autonomic nervous system and an effect of aeobic exercise
Region
| Japan |
Condition
Condition
knee and hip osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is;
1. to examine relationships between central sensitization and autonomic nervous system
2. to examine an effect of aerobic exercise for patients with knee and hip osteoarthritis
For aim 1, we will conduct observational study.
For aim 2, we will conduct a case study and randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conditioned pain modulation as a measure of central sensitization is a primary outcome of this study.
Measurements will be performed before and after interventions.
Key secondary outcomes
Numerical analog scale of knee pain (intensity of knee pain)
Heart rate variability (autonomic nervous activities)
Heart rate recovery when aerobic exercise (autonomic nervous activities)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, disability)
PainDETECT (neuropathic pain)
Pain Catastrophizing Scale (pain catastrophizing)
International Physical Activity Questionnaire (physical activity)
Hospital Anxiety and Depression Scale (anxiety and depression)
Pittsburgh Sleep Quality Index (sleep quality)
Checklist for Individual Strength (fatigue)
Basic characteristics (age, sex, diagnosis and level of OA, history of medicine, marital status, educational status, height, weight, body mass index, X-ray, medication, blood and urine sampling)
Measurements will be performed before and after interventions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group (hand ergometer: HE group) will perform hand ergometer using TERASUERUGO TE4-70 (Showa Denki Co., Ltd., Osaka, Japan) as aerobic exercise.
It is performed once per week for 12 weeks, and each exercise is ten minutes and three minutes for recovery time after the exercise.
Hand ergometer can choose a load of 20-70W.
A load for each participant is decided according to 60-75% of their predicted maximum heart rate (220 - age).
hand ergometer will be supervised by physical therapists of International University of Health and Welfare.
Furthermore, general self-exercise program for alleviating knee pain will mainly consist of flexibility and resistance training.
Compliance to self-exercise will be self-reported.
Interventions/Control_2
Control group (self-exersise: SE group) will perfomrm general self-exercise program for alleviating knee pain will mainly consist of flexibility and resistance training which are the same program as HE group.
Compliance to self-exercise will be self-reported.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
The inclusion criteria are;
(1) women with knee or hip osteoarthritis who are outpatients at International University of Health and Welfare Narita and Ichikawa Hospital
(2) lasting pain over three months
(3) patients and their orthopedists agree to participate this study
(4) body mass index is 18-35kg/m2
(5) positive sign of conditioned pain modulation (only case report and randomized controlled trials).
Key exclusion criteria
The exclusion criteria are;
(1) disabilities of cardiopulmonary vascular, central nervous and autonomic nervous system,
(2) facial, chest and abdominal pain
(3) cancer pain
(4) patients who took exercise or physical therapy within three months
(5) patients who is difficult to communicate and to answer questionnaire
(6) patients who take fallowing medications; beta- blocker, antidepressant and anticonvulsant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Uzawa |
Organization
International University of Health and Welfare
Division name
School of Health Science at Narita, Department of Physical Therapy
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
TEL
+81-476-20-7701
h.uzawa@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Uzawa |
Organization
International University of Health and Welfare
Division name
School of Health Science at Narita, Department of Physical Therapy
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
TEL
+81-476-20-7701
Homepage URL
h.uzawa@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3, Kozunomori, Narita-shi,Chiba-ken
Tel
+81-476-20-7701
h.uzawa@iuhw.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
国際医療福祉大学成田病院（千葉県）
国際医療福祉大学市川病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observation dn case study started from Februry, 2023.
Randomized controlled trial will start from May 2023.
Pricise protocol of randomized controlled trial will be submitted to a journal, and URL of the protocol will be updated in this site after publishing.
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055110
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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