UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042964 |
|---|---|
| Receipt number | R000049050 |
| Scientific Title | Effects of perioperative resistance training with high protein intake on muscle mass, strength and motor function after total hip arthroplasty |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2022/07/13 12:17:22 |
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Basic information
Public title
Effects of perioperative resistance training with high protein intake on muscle mass, strength and motor function after total hip arthroplasty
Acronym
Effects of resistance training with high protein for total hip arthroplasty
Scientific Title
Effects of perioperative resistance training with high protein intake on muscle mass, strength and motor function after total hip arthroplasty
Scientific Title:Acronym
Effects of resistance training with high protein for total hip arthroplasty
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using randomized control trial, this study examined the effects of resistance training with high protein intake on muscle mass, strength and motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Skeletal muscle mass
Muscle strength
Functional performance
Key secondary outcomes
Quality of life
inflammatory symptoms
nutritional status
energy intake
physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Interventions/ Resistance training and high protein nutrition before and after exercise for 12 weeks.
Interventions/Control_2
Control/ Resistance training for 12 weeks.
No nutritional intervention.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients with hip osteoarthritis who need the operation of total hip arthroplasty
2) patients have not severe medical or orthopedic disease
3)patients have not dementia or schizophrenic disorder
4) patients have not renal disorder who need to protein restriction (eGFR >50ml/min)
5) patients have not food allergies (milk igredients, apples)
6) patients have not past osteotomy surgery
7) patients that an agreement of participating this study is provided in a document
Key exclusion criteria
1) patients who are operated on revision
surgery
2) patients scheduled for arthroplasy with
osteotomy or hip adductor muscle dehiscence
3) othets who judged that a researcher was inappropriate
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | Ninomiya |
| Last name | Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
247-0061
Address
5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL
0467472377
k_ninomiya@skjrc.jp
Public contact
Name of contact person
| 1st name | Kazunari |
| Middle name | |
| Last name | Ninomiya |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Rehabilitation
Zip code
247-0061
Address
5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL
0467472377
Homepage URL
k_ninomiya@skjrc.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura Joint Reconstruction Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mirai Iryo Research Center
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan.
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
湘南鎌倉人工関節センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 12 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049050
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
