Cardiovascular DiseasesNCT00005414
Validation of a Historical Physical Activity Survey
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To compare long-term recall of physical activity up to 15 years in the past with physical activity reports and physical fitness levels assessed at the baseline examination. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Sep 1993
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To compare long-term recall of physical activity up to 15 years in the past with physical activity reports and physical fitness levels assessed at the baseline examination.
Read the detailed description
BACKGROUND:
Sedentary habits in middle-aged individuals are associated with increased risk for cardiovascular disease. Studies examining this association typically have assessed physical activity participation in a narrow window, (for example, 1 week or 1 month) relative to probable disease etiology and progression. When the study was initiated, the possible relation of long-term physical activity patterns over decades or a lifetime to disease risk was not known because there existed no validated method of determining such exposure, but such studies were needed. It was hypothesized that validation of long-term recall of activity could lead to the application of lifetime physical activity patterns questionnaires. Data on lifetime activity patterns might be useful in case-comparison and prospective studies of cardiovascular disease.
DESIGN NARRATIVE:
Data analyzed for this project were from a cohort that had been under observation in the Aerobics Center Longitudinal Study. Baseline preventive medical examinations were given to 6,902 men and women during the interval from 1971-1982. Current physical activity and physical fitness levels (maximal exercise treadmill test) were assessed at baseline. Participants also completed a lifetime physical activity pattern questionnaire as part of a mail survey done in 1986. Self-reported physical activity from the 1986 questionnaire was used to categorize participants' physical activity levels for the years 1971-1985. These recalled levels of activity were compared to physical activity and physical fitness levels assessed during those same years at the baseline examinations (measure of truth). For example, participants who reported in the 1986 survey that they engaged in relatively high levels of physical activity in 1976 were expected to have recorded higher levels of physical fitness at the 1976 examination than participants who reported in 1986 that they were relatively sedentary in 1976. The study design permitted evaluation of how accurately participants recalled their physical activity up to 15 years in the past and allowed quantification of the errors investigators might expect from such assessments.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1991
- Study completionSep 1993
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.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005414
- Sponsor's protocol ID
- 4332
- Other IDs
- R03HL047478
- Status last verified
- Jul 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Historical Physical Activity Survey
- ClinicalTrials.gov ID
- NCT00005414
- Acronym / sponsor ID
- 4332
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Study completion
- Sep 1993 (actual)
- First posted
- 26 May 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.
To compare long-term recall of physical activity up to 15 years in the past with physical activity reports and physical fitness levels assessed at the baseline examination.
Detailed description
BACKGROUND:
Sedentary habits in middle-aged individuals are associated with increased risk for cardiovascular disease. Studies examining this association typically have assessed physical activity participation in a narrow window, (for example, 1 week or 1 month) relative to probable disease etiology and progression. When the study was initiated, the possible relation of long-term physical activity patterns over decades or a lifetime to disease risk was not known because there existed no validated method of determining such exposure, but such studies were needed. It was hypothesized that validation of long-term recall of activity could lead to the application of lifetime physical activity patterns questionnaires. Data on lifetime activity patterns might be useful in case-comparison and prospective studies of cardiovascular disease.
DESIGN NARRATIVE:
Data analyzed for this project were from a cohort that had been under observation in the Aerobics Center Longitudinal Study. Baseline preventive medical examinations were given to 6,902 men and women during the interval from 1971-1982. Current physical activity and physical fitness levels (maximal exercise treadmill test) were assessed at baseline. Participants also completed a lifetime physical activity pattern questionnaire as part of a mail survey done in 1986. Self-reported physical activity from the 1986 questionnaire was used to categorize participants' physical activity levels for the years 1971-1985. These recalled levels of activity were compared to physical activity and physical fitness levels assessed during those same years at the baseline examinations (measure of truth). For example, participants who reported in the 1986 survey that they engaged in relatively high levels of physical activity in 1976 were expected to have recorded higher levels of physical fitness at the 1976 examination than participants who reported in 1986 that they were relatively sedentary in 1976. The study design permitted evaluation of how accurately participants recalled their physical activity up to 15 years in the past and allowed quantification of the errors investigators might expect from such assessments.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 16 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 16 Mar 2016.