UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041772 |
|---|---|
| Receipt number | 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 13:35:52 |
* 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
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
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
