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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038682
Receipt No. R000044092
Scientific Title A non-randomized study of fitness therapy for patients with malignant bone tumors in lower extremities
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/25

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Basic information
Public title A non-randomized study of fitness therapy for patients with malignant bone tumors in lower extremities
Acronym FOOT study
Scientific Title A non-randomized study of fitness therapy for patients with malignant bone tumors in lower extremities
Scientific Title:Acronym FOOT study
Region
Japan

Condition
Condition Malignant bone tumor in lower extremities
Classification by specialty
Hematology and clinical oncology Pediatrics Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify whether programmed self-rehabilitation changes the quality of life during or at the end of treatment compared with historical controls
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fatigue in QLQ-C30
Key secondary outcomes QOL survey (items other than fatigue in QLQ-C30)
Functional evaluation (MSTS leg, TESS)
Upper arm, thigh, proximal patella, muscle strength around the lower leg
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Rehabilitation
Program and teach rehabilitation that can be performed in about 30 minutes to 1 hour
Conduct this rehabilitation under self-management during the treatment period
Interventions/Control_2
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
12 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria Patients with malignant bone tumor of the lower limb
Surgery to remove the primary lesion is scheduled
Preoperative and postoperative chemotherapy is scheduled
Understand and answer questions on questionnaires
Concerning participation in this study, written consent has been obtained from the person himself / herself (in the case of age less than 20 years old when obtaining consent)
Key exclusion criteria (1) Patients who are physically difficult to rehabilitate
(2) Patients with heart and respiratory complications
(3) Other patients who are determined to be inappropriate as research subjects by the principal investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Akita
Organization National Hospital organization Nagoya Medical Center
Division name Department of pediatrics
Zip code 460-0001
Address 4-1-1 Sannomaru, Naka-ku, Nagoya
TEL 052-951-1111
Email nobuhiroakita0728@gmail.com

Public contact
Name of contact person
1st name Nobuhiro
Middle name Akita
Last name Akita
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Pediatrics
Zip code 492-8044
Address 4-1-1 Sannomaru, Naka-ku, Nagoya
TEL 052-951-1111
Homepage URL
Email nobuhiroakita0728@gmail.com

Sponsor
Institute National Hospital Organization (Nagoya Medical Center Clinical Research Center)
Institute
Department

Funding Source
Organization Non
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 National hospital organization Nagoya Medical Center
Address 4-1-1 Sannomaru, Naka-ku, Nagoya
Tel 052-951-1111
Email nobuhiroakita0728@gmail.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 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
2018 Year 02 Month 01 Day
Date of IRB
2018 Year 04 Month 19 Day
Anticipated trial start date
2019 Year 11 Month 22 Day
Last follow-up date
2024 Year 01 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
2019 Year 11 Month 25 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044092

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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