UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049050