Diabetes MellitusPhase 1/2NCT00106236
Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction
A Phase 1/2 study testing exercise in people with Diabetes Mellitus and Hypertension, run by Sapporo Health Promotion Foundation at 1 site in Japan.
Trial summary
The purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations. Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 561 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2003to Apr 2004
- Phase
- Phase 1/2
- 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 45 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 24.2-34.9 with 2 or more of the following risk factors:
- Resting systolic blood pressure of 130-179 mmHg
- Fasting blood glucose of 110-139 mg/dl, or HbA1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl
- LDL-cholesterol of 120-219 mg/dl
Who cannot join
- Diastolic blood pressure of 110 mmHg or greater
- History of clinical heart disease or stroke
- Orthopedic problems that might interfere with exercise
- Dementia
- Abnormal exercise EKG test results
- Private physician's disapproval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sapporo Fitness Club Trial (SFCT): A Randomized Controlled Trial to Test the Efficacy of Exercise at a Fitness Club for the Reduction of Cardiovascular Risk Factors
The purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.
Read the detailed description
Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. Past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. Does exercise differentially act on various risk factors in the same subject? Do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? To our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs.
Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month period. The second 6-month period is for follow-up and other purposes.
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Being tested
- exercise
- Keywords
- Exercise, Fitness Club, Randomized Controlled Trial, Cardiovascular Risk Factor, Overweight, Inactivity
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias, Motor Activity, Overweight, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
low-density lipoprotein cholesterol
hemoglobin A1c
Secondary outcomes (12)
Body weight
waist circumference
diastolic blood pressure
HDL-cholesterol
triglyceride
casual blood glucose
high-sensitivity C-reactive protein
white blood cell count
estimated VO2max
bicycle time
leg muscle strength
health-related QOL (Quality of Life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2005 (estimated)
- Study startApr 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 561 participants
Sponsor and investigators
- Lead sponsor
- Sapporo Health Promotion Foundation
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106236
- Sponsor's protocol ID
- SHPCR-2003-1
- Status last verified
- Mar 2005
- First submitted
- 21 Mar 2005
- Last updated
- 14 Jul 2009
- Results posted
- No
Publications
Igarashi K, Fujita K, Yamase T, Morita N, Okita K, Satake K, Kanazawa N, Nishijima H. Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--. Circ J. 2004 Dec;68(12):1199-204. doi: 10.1253/circj.68.1199.
PubMed 15564707
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sapporo Fitness Club Trial (SFCT): A Randomized Controlled Trial to Test the Efficacy of Exercise at a Fitness Club for the Reduction of Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00106236
- Acronym / sponsor ID
- SHPCR-2003-1
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Keywords
- Exercise, Fitness Club, Randomized Controlled Trial, Cardiovascular Risk Factor, Overweight, Inactivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants
- Lead sponsor
- Sapporo Health Promotion FoundationUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Apr 2004
- First posted
- 22 Mar 2005 (estimated)
- 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 purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.
Detailed description
Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. Past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. Does exercise differentially act on various risk factors in the same subject? Do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? To our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs.
Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month period. The second 6-month period is for follow-up and other purposes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resting systolic blood pressure of 130-179 mmHg
- Fasting blood glucose of 110-139 mg/dl, or HbA1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl
- LDL-cholesterol of 120-219 mg/dl
Key exclusion criteria (6 listed)
- Diastolic blood pressure of 110 mmHg or greater
- History of clinical heart disease or stroke
- Orthopedic problems that might interfere with exercise
- Dementia
- Abnormal exercise EKG test results
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 |
|---|---|---|
| exercise | Behavioural | – |
Primary outcome
Systolic blood pressure
low-density lipoprotein cholesterol
hemoglobin A1c
12 secondary outcomes
Body weight
waist circumference
diastolic blood pressure
HDL-cholesterol
triglyceride
casual blood glucose
high-sensitivity C-reactive protein
white blood cell count
estimated VO2max
bicycle time
leg muscle strength
health-related QOL (Quality of Life)
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 14 Jul 2009.
- Background: PubMed 15564707Igarashi K, Fujita K, Yamase T, Morita N, Okita K, Satake K, Kanazawa N, Nishijima H. Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--. Circ J. 2004 Dec;68(12):1199-204. doi: 10.1253/circj.68.1199.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing exercise in people with Diabetes Mellitus and Hypertension, run by Sapporo Health Promotion Foundation 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 4 inclusion and 6 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 14 Jul 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Systolic blood pressure. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106236, which also lists 1 linked publication.
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 14 Jul 2009.