UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041772
Receipt No. R000040281
Scientific Title Feasibility and effect of prehabilitation program
Date of disclosure of the study information 2020/09/13
Last modified on 2020/09/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Feasibility and effect of prehabilitation program
Acronym Feasibility and effect of prehabilitation program
Scientific Title Feasibility and effect of prehabilitation program
Scientific Title:Acronym Feasibility and effect of prehabilitation program
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The effect of prehabilitation on postoperative physical function
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 6MWT
WHODAS
QOR40
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 prehabilitation
Interventions/Control_2 None
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients aged 65 and over
2) Lung cancer patients
3) Patients undergoing lobectomy with thoracoscopic assistance (with or without lymph node dissection
4) Patients who can secure a period of 21 days or more from the decision to surgery
Key exclusion criteria 1) Patients who do not agree
2) Patients with stage III and IV (% FEV1 less than 50%) chronic obstructive pulmonary disease
3) Patients undergoing home oxygen therapy
4) Patients with manual muscle strength measurement of 2 or less
5) Patients undergoing dialysis
6) Patients visiting a psychiatric clinic
7) Patients with inborn errors of metabolism
8) Patients with problems eating and swallowing
9) Patients who meet the following cancer rehabilitation discontinuation criteria
1. Blood findings: hemoglobin 7.5 g / dl or less, platelets 50,000 / ul or less, white blood cells 3,000 ul or less
2. Findings of metastasis of long bones with invasion of 50% or more of the bone cortex, bone erosion toward the center of the bone, lesions of 3 cm or more of the femur, etc.
3. Compression of cavities, blood vessels, and spinal cord
4. Exudate retention in the pleura, peritoneum, and retroperitoneum due to pain, dyspnea, and restricted movement
5. Central nervous system dysfunction, impaired consciousness, increased intracranial pressure
6. Low / hyperkalemia, low / hypernatremia, low / hypercalcemia
7. Orthostatic hypotension, hypertension of 160/100 mmHg or higher
Tachycardia of 8.110 / min or more, ventricular arrhythmia
Target sample size 68

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name Ida
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 634-8521
Address Shijo-machi
TEL 09079627114
Email nwnh0131@yahoo.co.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address Shijo-machi
TEL 09079627114
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization JST
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Nara

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University
Address Shijo-machi
Tel 0744368521
Email nwnh0131@yahoo.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 13 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
2020 Year 01 Month 31 Day
Date of IRB
2020 Year 01 Month 08 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2024 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 13 Day
Last modified on
2020 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.