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The primary objective of this study is to explore the effect of an exercise program combining aerobic and resistance exercises provided by mobile healthcare applications (hereinafter referred to as "app") on the body composition in app-using exercise group compared to non-exercise group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Participants will conduct exercise programs provided by the app 3 times a week for 12 weeks. Except for the exercise program provided by the app, the amount of activity and exercise in daily life will not change from before the study. |
|
| Non-exercise group | Other | Participants will not change the amount of activity or exercise in daily life from before the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Exercise program |
| |
| No exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in visceral fat area | Visceral fat area will be measured with computed tomography (CT). | Baseline and Week 12 |
| Change from baseline in body fat ratio | Total fat ratio will be derived from body composition analyzer. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in subcutaneous fat area | Subcutaneous fat area will be measured with CT. | Baseline and Week 12 |
| Change from baseline in total fat area | Body fat area will be measured with CT. |
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Inclusion Criteria:
Subjects who can perform a 12-week exercise program using the specified app during the study in Japan if they are assigned to the app-using exercise group.
Subjects who agree to perform a 12-week exercise program using the app during the period specified in the protocol and not to change activities/exercise of daily living compared with before participation in the study except for the exercise program using the app if they are assigned to the app-using exercise group, or subjects who agree not to change activities/exercise of daily living compared with before participation in the study during the period specified in the protocol if they are assigned to the non-exercise group.
Subjects with body mass index (BMI) of 25.0 kg/m^2 or more and less than 30.0 kg/m^2 at screening and baseline
Subjects with waist circumferences meeting the following at screening and baseline. Male: 85 cm or more, Female: 90 cm or more
Female subject who applied to one of the following
Subjects who agree not to participate in clinical studies of drugs, regenerative medicine products, or medical devices, post-marketing clinical studies, or clinical research (including studies that do not use drugs, regenerative medicine products, or medical devices as with this study) other than this study after providing informed consent until the completion of the examination/observation at Week 12.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astellas Pharma Inc. | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Toshima-ku | Tokyo | Japan |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Behavioral |
No exercise program |
|
| Baseline and Week 12 |
| Change from baseline in muscle mass | Muscle area will be measured with body composition analyzer. | Baseline and Week 12 |
| Change from baseline in waist circumference | Waist circumference will be measured with measuring tape. | Baseline and Week 12 |
| Change from baseline in body weight | Body weight will be measured with body composition analyzer. | Baseline and Week 12 |
| Number of participants with Adverse Events (AEs) | An adverse event is any untoward medical occurrence in subjects, which does not necessarily have to have a causal relationship with this study. An event that meets either "possibly related" or "probably related" is defined as "an adverse event whose causal relationship with this study cannot be ruled out" or "an adverse event whose causal relationship with the exercise intervention cannot be ruled out." | Up to Week 12 |