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Effect of home- and app-based training on fatigue among breast cancer survivors

Effect of home- and app-based high-intensity interval training next generation on fatigue among breast cancer survivors: A multicenter randomized controlled trial - habit Next

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030220594
Enrollment
140
Registered
2023-01-30
Start date
2023-01-23
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

The intervention consists of a newly developed exercise support app and 6-week online home exercise support (exercise counselling and instruction, once per week, 6 sessions in total, 30 min/session).
(2) an exercise diary (daily symptoms, subjective exercise intensity and feedback on exercise)
(3) monitoring of maximum heart rate during exercise (automatically recorded by a wearable device [Fitbit Inspire2
Fitbit Inc., San Francisco, CA])
(4) motivation to exercise (feedforward based on subjective exercise intensity during exercise [rate of perceived exertion: RPE], feedback comments, provision of incentives and feedback from others wh
(5) checking the status of exercise (dates of exercise, subjective exercise intensity, maximum heart rate and feedback on exercise)
and (6) information on cancer research and exercise. Participants will perform the following exercise program 3 times per week for 12 weeks (36 sessions in total during the study period): a 10-min ses

Sponsors

Suto Akihiko
Lead Sponsor
The Japan Agency for Medical Research and Development
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) women aged over 20 years (2) diagnosis of Stage I-III invasive breast cancer (3) within 13 months of completing initial cancer treatment with curative intent (including hormone therapy and radiation therapy) (4) scoring 1 on a 1-item fatigue numerical rating scale (5) no exercise habits (2 days per week of light sweat-inducing exercise for 30 min/session in a typical week) (6) access to a smart phone (7) willing to provide written informed consent for study participation (8) able to read, write and understand Japanese.

Exclusion criteria

Exclusion criteria: (1) primary physician determined severe cognitive decline (2) primary physician determined exercise risk (3) difficulty performing basic activities (e.g., walking, running, jumping and riding a bicycle) (4) comorbidities affecting physical activity (e.g., anaemia, heart failure, chronic obstructive pulmonary disease and musculoskeletal disease) (5) BMI over 30.

Design outcomes

Primary

MeasureTime frame
Multidimensional Fatigue Inventory (MFI)

Secondary

MeasureTime frame
Body mass VO2 peak Grip Strength sit to stand test fitbit CRF CFS FACT B HADS PRO CTCAE WHO HPQ EQ 5D 5L medical fee steps sleep time Adverse event adherence LVEF GLS Troponin BNP NT proBNP Framingham Risk Score

Contacts

Public ContactEisuke Ochi

Hosei Univeristy

ochi@hosei.ac.jp+81-42-387-6337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026