UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053974 |
|---|---|
| Receipt number | R000061607 |
| Scientific Title | Effects of an exercise intervention on physical functioning and quality of life:A systematic review |
| Date of disclosure of the study information | 2024/03/26 |
| Last modified on | 2024/03/26 15:29:55 |
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Basic information
Public title
Effects of an exercise intervention on physical functioning and quality of life of community-dwelling breast cancer survivors: A systematic review and meta-analysis of randomized trials
Acronym
Effects of an exercise intervention on physical functioning and quality of life:A systematic review
Scientific Title
Effects of an exercise intervention on physical functioning and quality of life:A systematic review
Scientific Title:Acronym
Effects of an exercise intervention on breast cancer survivors:A systematic review
Region
| Japan |
Condition
Condition
breast cancer survivors
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present systematic review was to identify the benefits and methods of walking and strength exercises that can be performed at home by community-dwelling breast cancer survivors.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect on physical function
Key secondary outcomes
Effect on alleviating cancer-related symptoms
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)studies involving home-based breast cancer survivors after completion of primary treatment 2)over18 years old 3)studies utilizing walking,strength,and activity RCT interventions at home,and 4)studies with outcomes are physical functioning, symptom relief,psychological and QOL
Key exclusion criteria
1)studies involving patients with other types of cancer not just breast cancer; 2)inclusion of subjects undergoing treatment for breast cancer; 3) studies utilizing exercise as part of rehabilitation at a fitness center or through regular hospitalization; and 4) studies requiring intense exercise,such as 10,000 steps/day in the control group
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kanda |
Organization
Niigata College of Nursing
Division name
Department of Nursing
Zip code
943-0147
Address
240 Shinnan-cho,Joetsu City,Niigata
TEL
+818010991085
kkanda@niigata-cn.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kanda |
Organization
Niigata College of Nursing
Division name
Depart of Nursing
Zip code
943-0147
Address
240 Shinnan-cho,Joetsu City,Niigata
TEL
0255262811
Homepage URL
kkanda@niigata-cn.ac.jp
Sponsor or person
Institute
Niigata College of Nursing
Institute
Department
Personal name
Kanda Kiyoko
Funding Source
Organization
MEX
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gunma university
Takasaki university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Niigata College of Nursing
Address
Niigata College of Nursing
Tel
0255262811
ayamazaki@j.niigata-cn.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
| 2024 | Year | 03 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Only randomized controlled trials (RCTs) were selected as the study type. The selection criteria included 1) studies involving home-based breast cancer survivors after completion of primary treatment 2)over18 years old 3) studies utilizing walking, strength, and activity RCT interventions at home, and 4) studies with outcomes are physical functioning, symptom relief, mental (psychological) and quality of life.
The exclusion criteria were as follows: 1) studies involving patients with other types of cancer, not just breast cancer; 2) inclusion of subjects undergoing treatment for breast cancer; 3) studies utilizing exercise as part of rehabilitation at a fitness center or through regular hospitalization; and 4) studies requiring intense exercise, such as 10,000 steps/day in the control group, were excluded for sustainability reasons.
Management information
Registered date
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061607
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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