UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036400 |
|---|---|
| Receipt number | R000041451 |
| Scientific Title | Effect of home-based high intensity intermittent training and behavioral modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomized controlled trial |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2021/10/07 19:51:33 |
* 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
Effect of home-based high intensity intermittent training and behavioral modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomized controlled trial
Acronym
Development of home-based exercise program for breast cancer survivors: habit-B
Scientific Title
Effect of home-based high intensity intermittent training and behavioral modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomized controlled trial
Scientific Title:Acronym
Development of home-based exercise program for breast cancer survivors: habit-B
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether habit-B program improves the VO2 peak compared to a control group as well as to confirm its safety and feasibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiorespiratory fitness: VO2 peak
Key secondary outcomes
Physical Function: six-minute walk test (m), Walking speed (m/sec), One-repetition maximum (1RM) for leg press, Grip strength, chair stand test, functional reach test, two-step test, body composition
Physical Activity Level: Global Physical Activity Questionnaire (GPAQ) , wearable activity monitor
Subjective Measures: Fear of cancer recurrence (FCR), Concerns About Recurrence Scale (CARS), Patient Health Questionnaire-9 (PHQ-9), Cancer Fatigue Scale (CFS), Athens Insomnia Scale (AIS), EuroQol 5 Dimension (EQ-5D)
Adverse event rate
Biological assessments: gut microbiota, intestinal metabolite, intestinal immunity, Blood polyunsaturated fatty acids
Medical economical cost: cost-benefit analysis, number of staffs, working hours, labor cost, equipment costs, office expenses, number of unexpected medical consultations, direct medical cost, other medical service usage
Return to work
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
habit-B program group
The habit-B program will be combined with home-based exercise support utilizing six weeks of exercise counseling/exercise guidance and twelve weeks of ICT (e-mail, application, wearable device). The participants will encourage to complete the following high intensity interval training (HIIT) using body weight exercises below 10-minute training session three times each week for twelve weeks (a total of 36 sessions during the trial period): (1) one 10-minute session of exercises focused on the lower limbs; (2) a total of 10 minutes composed of a 3-minute warm-up, 4-minute training (8 sets of 20 sec exercise, 10 sec rest), and 3-minute cool-down; (3) the above training exercises are designed to increase in intensity each week; (4) the details of the above exercises are divided into three stages according to cardiorespiratory fitness (VO2 peak) at Week 0 and the contents of training are designed to increase physical strength incrementally in accordance with the individual's level of strength.
Interventions/Control_2
Control group
In the control group, wearable devices will be distributed and support provided for setup at the start of the intervention. Self-monitoring using the wearable device will be recommended during the trial period. There are no reports of increasing VO2 peak with the use of a wearable device alone, and there are reports ruling out their efficacy with regard to effects on exercise habits. In this study the control group will utilize wearable devices for the purpose of monitoring physical activity.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) female, ages 20 to 59 years diagnosed (stages I-IIa); (2) diagnosed with invasive breast cancer, within 2 to 13 months after surgery; (3) not requiring cancer drug treatment aside from hormone therapy; (4) less than two days of 30 min (in total of 60 min) per week over moderate intensity); (5) ability to complete an electronic patient reported outcome (e-PRO) using smartphone; (6) consent to trial participation can be obtained in writing from the patient themselves; and (7) can read, write, and understand Japanese.
Key exclusion criteria
(1) judged to have severely reduced cognitive function by a primary physician; (2) exercise judged to be risky by a primary physician; (3) history of smoking within in the previous 12 months; (4) BMI of 30 or above; (5) ECG abnormality indicated in preoperative testing, resting heart rate (HR) below 60 beats/min or above 100 beats /min, stage III hypertension or above (diastolic blood pressure over 110 mmHg or systolic blood pressure of over 180 mmHg); (6) judged unfit for the trial by a primary physician for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Matsuoka |
Organization
National Cancer Center
Division name
Center for Public Health Sciences
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335475201
yumatsuo@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Shimizu |
Organization
National Cancer Center Hospital
Division name
Division of Nursing
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335475201
Homepage URL
yoshimiz@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
tomishid@ncc.go.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
| 2019 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/8/e030911
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1136/bmjspcare-2021-003141
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 13 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2019 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041451
