Cardiovascular DiseasesNCT00000108
Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women
A study testing Exercise in people with Cardiovascular Diseases and Coronary Disease, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal and preferably on hormone replacement therapy
- In good general health
- Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40
- Exercise less than 20 min/day two days a week
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
3060G Central Campus Recreation Bldg 401 Washtenaw Ave.
Ann Arbor, Michigan, 48109-2214
About this study
The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CVD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CVD.
- Conditions
- Cardiovascular Diseases, Coronary Disease
- Being tested
- Exercise
- Keywords
- exercise
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000108
- Sponsor's protocol ID
- NCRR-M01RR00042-1647
- Other IDs
- M01RR000042
- Status last verified
- Dec 2003
- First submitted
- 18 Jan 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00000108
- Acronym / sponsor ID
- NCRR-M01RR00042-1647
- Conditions
- Cardiovascular Diseases, Coronary Disease
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 19 Jan 2000 (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 this research is to find out whether training at different exercise intensities reduces the risk of developing cardiovascular disease (CVD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CVD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat level before you start training and after 15 and 30 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CVD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal and preferably on hormone replacement therapy
- In good general health
- Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40
- Exercise less than 20 min/day two days a week
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 24 Jun 2005.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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 study testing Exercise in people with Cardiovascular Diseases and Coronary Disease, run by National Center for Research Resources (NCRR) at 1 site in United States.
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 0 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 24 Jun 2005. 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 United States. 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.
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 24 Jun 2005.