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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042964
Receipt No. 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 2021/01/10

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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
Email 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
Email k_ninomiya@skjrc.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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