A Study to Assess Effect of Exercise Program Provided by Smartphone Application on the Body Composition

Astellas Pharma Inc1 site in 1 country100 target enrollmentDecember 25, 2019

ConditionsHealthy Volunteers

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Astellas Pharma Inc
Enrollment: 100
Locations: 1
Primary Endpoint: Change from baseline in body fat ratio
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 25, 2019

End Date

June 8, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility Criteria

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 are postmenopausal (without a menstrual period for at least 1 year) at the time of informed consent.
•Subjects of non-childbearing potential due to undergoing surgery.
•Females of childbearing potential who agree to use contraception during the participation in the study and have a negative pregnancy test at screening and baseline.
•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

•Subjects who regularly perform at least 1 session of exercise per week for at least 30 minutes per session on average other than activities of daily living during 6 months before providing informed consent.
•Subjects who receive treatment for obesity on an outpatient basis at the time of informed consent or plan to start treatment for obesity on an outpatient basis during the period until the completion of the examination/observation at Week
•Subjects whose systolic blood pressure (sitting position at rest) is 160 mmHg or more or whose diastolic blood pressure (sitting position at rest) is 100 mmHg or more at screening or baseline.
•Subjects with concomitant uncontrolled hypertension or concomitant hypertension that is considered likely to be exacerbated by the exercise intervention.
•Subjects with previous or concomitant severe heart diseases (ischemic heart disease, myocardial infarction, congestive heart failure, angina pectoris, and arrhythmia requiring treatment with β-blockers and other drugs, etc.).
•Subjects with previous or concomitant cerebrovascular disorders (cerebral infarction, transient cerebral ischemia, etc.).
•Subjects with fasting blood glucose of 250 mg/dL or more or with positive urinary ketone bodies at screening.
•Subjects with concomitant uncontrolled diabetes or with diabetic complications (diabetic neuropathy, diabetic nephropathy, and diabetic retinopathy excluding simple retinopathy).
•Subjects with concomitant retinal neovascular lesions (exudative age-related macular degeneration, retinal vein occlusion, etc.) or concomitant retinopathy occurring within 6 months after laser photocoagulation.
•Subjects with previous or concomitant arteriosclerosis obliterans of lower extremities