UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025775 |
|---|---|
| Receipt number | R000029647 |
| Scientific Title | The relationship between physical fitness changing and QOL in Gynecologic cancer patients who are performed medical therapy ( chemotherapy and radiation therapy) |
| Date of disclosure of the study information | 2017/01/21 |
| Last modified on | 2019/03/22 18:38:20 |
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Basic information
Public title
The relationship between physical fitness changing and QOL in Gynecologic cancer patients who are performed medical therapy ( chemotherapy and radiation therapy)
Acronym
The relationship between physical fitness changing and QOL in Gynecologic cancer patients who are performed medical therapy ( chemotherapy and radiation therapy)
Scientific Title
The relationship between physical fitness changing and QOL in Gynecologic cancer patients who are performed medical therapy ( chemotherapy and radiation therapy)
Scientific Title:Acronym
The relationship between physical fitness changing and QOL in Gynecologic cancer patients who are performed medical therapy ( chemotherapy and radiation therapy)
Region
| Japan |
Condition
Condition
Gynecologic cancer patients
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effective rehabilitation methods by verifying the relationship between physical fitness changing and QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EORTCQLQ-C30 at the point of pre-rehabilitation and discharge
Key secondary outcomes
Knee extensor strength , grip power , timed up and go test, shuttle stamina walk test, long-sitting body anteflexion, 10-second Open-Close Stepping Test at the point of pre-rehabilitation and discharge
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
Gynecologic cancer patients who were performed physical therapy and medical treatment(radiation therapy and chemotherapy)
Key exclusion criteria
No research cooperation and understanding each assessment,inability to walk alone,mental disease, bone metastatic disease,excessive pain
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Minami |
| Middle name | |
| Last name | Takahashi |
Organization
Kochi Medical School Hospital
Division name
Rehabilitation Center
Zip code
7838505
Address
Kohasu Oko-cho Nankoku City Kochi 783-8505,Japan
TEL
088-880-2490
jm-takahashi-m@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Takahashi |
Organization
Kochi Medical School Hospital
Division name
Rehabilitation Center
Zip code
7838505
Address
Kohasu Oko-cho Nankoku City Kochi 783-8505,Japan
TEL
088-880-2490
Homepage URL
jm-takahashi-m@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School Hospital
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
Kochi Medical School Hospital
Address
Kohasu Oko-cho Nankoku City Kochi 783-8505,Japan
Tel
088-880-2490
m-takahashi-m@kochi-u.ac.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
| 2017 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
QOL(physical function) significantly correlated with shuttle stamina walk test at the point of pre-rehabilitation, but not at discharge.
Results date posted
| 2019 | Year | 03 | Month | 22 | Day |
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The exercise is 5minuets resistance training using Thera-Band in sitting position and 20minuets aerobic exercise using ergometer. The exercise intensity is defined by Borg scale13.The exercise load is changed by patients muscle fatigue next day.
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
