UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062541 |
|---|---|
| Receipt number | R000071590 |
| Scientific Title | Feasibility of a Pickleball Intervension and Its Impact on Quality of Life in Breast Cancer Survivors |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/10 15:38:37 |
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Basic information
Public title
Feasibility of a Pickleball Intervension and Its Impact on Quality of Life in Breast Cancer Survivors
Acronym
Pickleball Intervention in Breast Cancer Surviviors
Scientific Title
Feasibility of a Pickleball Intervension and Its Impact on Quality of Life in Breast Cancer Survivors
Scientific Title:Acronym
Pickleball Intervention in Breast Cancer Surviviors
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the feasibility and safety of a pickleball exercise program for breast cancer survivors and to explore its effects on quality of life, psychological well-being, physical function, and physical activity. The findings will provide preliminary data for a future multicenter randomized controlled trial.
Basic objectives2
Others
Basic objectives -Others
To evaluate the feasibility and safety of a pickleball exercise intervention in breast cancer survivors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility (recruitment rate, attendance rate, completion rate, and dropout rate) and safety (incidence and characteristics of adverse events) of the pickleball exercise program.
Key secondary outcomes
Changes from baseline to post-intervention in quality of life (FACT-B), psychological status (HADS), physical function (6-minute walk test, 30-second chair stand test, and sit-and-reach test), physical activity (IPAQ), and social support, as well as participant satisfaction with the program at the end of the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A supervised pickleball exercise program will be conducted for 60 minutes per session, twice weekly for 8 weeks, under the guidance of certified coaches. The program will consist of warm-up, basic skill practice, game-based pickleball activities, and cool-down.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who have undergone surgery for breast cancer and are at least 3 months postoperatively
Individuals considered medically fit to participate in exercise by their treating physician
Women aged 20 to 79 years
Individuals who have received an adequate explanation of the study and provided written or electronic informed consent voluntarily
Individuals able to participate in a 60 minute pickleball exercise program twice weekly for 8 weeks
Key exclusion criteria
Inadequate healing of the surgical wound after breast cancer surgery.
Active thrombosis.
Severe cardiovascular or respiratory disease that may preclude safe participation in exercise.
Severe musculoskeletal or neurological conditions that make participation in pickleball exercise difficult.
Any other condition judged by the principal investigator or treating physician to make participation inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Matsuda |
Organization
mammaria tsukiji
Division name
Breast surgical oncology
Zip code
1040045
Address
5F Tsukiji Sky Building, 3-7-2 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3545-0880
tsukiji@mammaria.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Matsuda |
Organization
mammaria tsukiji
Division name
Breast surgical oncology
Zip code
1040045
Address
5F Tsukiji Sky Building, 3-7-2 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3545-0880
Homepage URL
tsukiji@mammaria.jp
Sponsor or person
Institute
mammaria tsukiji
Institute
Department
Personal name
Funding Source
Organization
Pickleball Japan Federation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Lukes International Hospital
Address
9-1, Akashicho, Chuo-ku, Tokyo, Japan
Tel
03-3541-5151
kenkyukikaku@luke.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
| 2026 | Year | 09 | Month | 01 | 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
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071590
