UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025775
Receipt No. 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

* 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 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 Obsterics 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
Email 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
Email jm-takahashi-m@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.