Healthy VolunteersNCT04194697
A Study to Assess Effect of Exercise Program Provided by Smartphone Application on the Body Composition
A study testing Exercise and No exercise in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Exercise and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 25 Dec 2019to 8 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.).
Show all 23Show fewer
- 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.
- Subjects with previous or concomitant schizophrenia, psychiatric disorders such as bipolar disorder or major depressive disorder, or dementia.
- Subjects who are taking any of the following drugs at the time of informed consent: insulin preparations, sulfonyl urea hypoglycemic agents, short-acting insulin secretagogues (glinide), Glucagon-like peptide (GLP)-1 receptor agonists, biguanides, thiazolidines, Sodium-glucose co-transporter (SGLT)2 inhibitors, and anti-obesity drugs, or subjects who plan to receive any of these drugs during the period until the completion of the examination/observation at Week 12.
- Subjects who are taking any of the following at the time of informed consent: antidyslipidemic agents or drugs affecting lipid metabolism, supplements, and health foods (including foods for specified health use and foods with functional claims), or subjects who plan to take any of these during the period until the completion of the examination/observation at Week 12. However, subjects are allowed to take these drugs, supplements, or foods if they can take them with a stable dosage from at least 28 days before baseline until the completion of the examination/observation at Week 12.
- Subjects who have metal placed by lumbar spinal surgery and other surgery at the site where abdominal CT scan is performed.
- Subjects with implantable medical devices such as cardiac pacemakers and implantable defibrillators.
- Subjects who have participated or are participating in clinical studies of other 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) within 12 weeks (84 days) before screening.
- Subjects who are employed by the research implementing entity of this study or institutions/organizations related to this study.
- Subjects who are considered ineligible for the participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exercise, No exercise
- Keywords
- Exercise program, Smartphone application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise program
No exerciseBehavioural
No exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| Non-exercise group | Other | Participants will not change the amount of activity or exercise in daily life from before the study. Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visceral fat area
Visceral fat area will be measured with computed tomography (CT).
Measured: Baseline and Week 12
Change from baseline in body fat ratio
Total fat ratio will be derived from body composition analyzer.
Measured: Baseline and Week 12
Secondary outcomes (6)
Change from baseline in subcutaneous fat area
Subcutaneous fat area will be measured with CT.
Measured: Baseline and Week 12
Change from baseline in total fat area
Body fat area will be measured with CT.
Measured: Baseline and Week 12
Change from baseline in muscle mass
Muscle area will be measured with body composition analyzer.
Measured: Baseline and Week 12
Change from baseline in waist circumference
Waist circumference will be measured with measuring tape.
Measured: Baseline and Week 12
Change from baseline in body weight
Body weight will be measured with body composition analyzer.
Measured: 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."
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start25 Dec 2019
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas Pharma Inc., Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194697
- Sponsor's protocol ID
- 4646-CL-0001
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2019
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Effect of Exercise Program Provided by Smartphone Application on the Body Composition
- ClinicalTrials.gov ID
- NCT04194697
- Acronym / sponsor ID
- 4646-CL-0001
- Conditions
- Healthy Volunteers
- Keywords
- Exercise program, Smartphone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseParticipants 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 | Behavioral: No exerciseParticipants will not change the amount of activity or exercise in daily life from before the study. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise program | Behavioural | Exercise group |
| No exerciseNo exercise program | Behavioural | Non-exercise group |
Primary outcome
Change from baseline in visceral fat area
Time frame: Baseline and Week 12
Visceral fat area will be measured with computed tomography (CT).
Change from baseline in body fat ratio
Time frame: Baseline and Week 12
Total fat ratio will be derived from body composition analyzer.
6 secondary outcomes
Change from baseline in subcutaneous fat area
Time frame: Baseline and Week 12
Change from baseline in total fat area
Time frame: Baseline and Week 12
Change from baseline in muscle mass
Time frame: Baseline and Week 12
Change from baseline in waist circumference
Time frame: Baseline and Week 12
Change from baseline in body weight
Time frame: Baseline and Week 12
Number of participants with Adverse Events (AEs)
Time frame: Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. 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/.
Related trials for Healthy Volunteers
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astellas Pharma Inc. study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visceral fat area (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.