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
Not Applicable
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000036400
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiorespiratory fitness: VO2 peak
- Secondary Outcome Measures
Name Time Method 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