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

NCT04194697 | Completed

• 1 other identifier: 4646-CL-0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Exercise program; Smartphone application

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Change from baseline in subcutaneous fat area

  Baseline and Week 12

• Change from baseline in total fat area

  Baseline and Week 12

• Change from baseline in muscle mass

  Baseline and Week 12

• Change from baseline in waist circumference

  Baseline and Week 12

• Change from baseline in body weight

  Baseline and Week 12

Study Arms (2)

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.

Behavioral: Exercise

Non-exercise group

OTHER

Participants will not change the amount of activity or exercise in daily life from before the study.

Behavioral: No exercise

Interventions

Exercise BEHAVIORAL

Exercise program

Exercise group

No exercise BEHAVIORAL

No exercise program

Non-exercise group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 12.
• 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
• Subjects with concomitant motor disorders.
• Subjects with concomitant severe respiratory diseases.
• Subjects with concomitant severe liver diseases (viral hepatitis, drug-induced liver injury, etc.).
• Subjects with concomitant severe renal diseases (acute renal failure, glomerulonephritis, interstitial nephritis, etc.).
• Subjects with previous or concomitant malignancies. However, subjects are allowed to be enrolled if they have experienced no recurrence without the need for treatment within 5 years before providing informed consent.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Toshima-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Astellas Pharma Inc.

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 25, 2019
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)