AgingNCT01212978
Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis
A study testing Pedometer to Increase Physical Activity in people with Aging and Cardiology, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic exercise on most days ( ≥5 days) of the week. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cardiology, Nitric Oxide
- What is being tested?
- Pedometer to Increase Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 1 Jul 2013
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 and ≤90 years of age
- Able to Ambulate without an Assist Device
Who cannot join
- History of Uncontrolled Diabetes Mellitus (Type 1 or 2) HgA1C >9.0%
- Uncontrolled hypertension with a blood pressure greater than 160/100 mmHg at the screening visit.
- Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
- Known history of cognitive impairment or inability to follow study procedures
- History of limb amputation other than toes
- History or Reynaud's Disease
- Unable to button a shirt or blouse
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from data supporting that regular physical activity reduces the risk of adverse cardiovascular events A portion of these benefits may be from reductions in the incidence and severity of cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.
While this recommendation for physical activity has been in existence for almost 15 years, the rates of obesity in the United States continue to rise and prevalence of sedentarism remains at best unchanged. Researchers have been engaged in investigating novel interventions to designed increase physical activity to reach the recommended activity targets. One promising intervention involves use of inexpensive, easy to use pedometers that allow individuals to objectively track the number of steps taken during a set period of time. Recent data suggest that an average of 10,000 steps/day as measured by a pedometer accurately estimates the activity levels recommended by the AHA, ASCM, and US government public health guidelines.
While the benefits of habitual exercise are well-documented, there are no data that demonstrate current recommendations for moderate physical activity in older adults by the ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events. Interestingly, prior work indicates that pedometer-centered interventions can increase physical activity, suggesting that this type of intervention could potentially lead to cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including brachial artery endothelial function, tonometric measurements of vascular stiffness, and measurements derived from transthoracic echocardiography, we will determine whether increasing the physical activity of sedentary adults to an average of 10,000 steps or more/day translates into improvements in cardiovascular health. This will be determined in the context of a randomized control trial employing a control group, a study group that uses a pedometer alone, and an intervention that couples a pedometer with internet-based motivational messaging software demonstrated in our preliminary data to encourage older adults to reach and exceed the 10,000 steps/day goal.
- Conditions
- Aging, Cardiology, Nitric Oxide
- Being tested
- Pedometer to Increase Physical Activity
- Keywords
- Aging, Endothelium,Vascular, Arterial Remodeling, Ventricular Vascular Coupling, Nitric Oxide, Walking, Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer to Increase Physical ActivityBehavioural
Also called Omron Pocket Pedometer
The pedometer will be given to arms 2 and 3 (pedometer only and pedometer+software intervention) to help them guide their increase in physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention | No intervention | These subjects will neither receive a pedometer or access to the motivational software until completion of the study. |
| Pedometer only | Active comparator | Participants in the this arm will receive a pedometer with instructions to reach a goal of 10,000 steps/day but will not receive access to the motivational software. Receives: Behavioral: Pedometer to Increase Physical Activity |
| Pedometer + Motivational Software | Experimental | In this arm, subjects will receive access to both a pedometer and motivational software Receives: Behavioral: Pedometer to Increase Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow induced Dilation of the Brachial Artery (FMD%)
Measured: 12 weeks
Secondary outcomes (2)
Left Ventricular Systolic Performance
Ventricular systolic stiffness and arterial elastance
Measured: 12 weeks
Left Ventricular Diastolic Function
Use of multiple echocardiographic parameters to measure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study start1 Sep 2010
- Primary completion1 Jul 2013
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Michael E. Widlansky, Medical College of Wisconsin
- Investigators
- Michael E Widlansky, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212978
- Sponsor's protocol ID
- MCW-MEW2
- Other IDs
- 10GRNT3880044
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2010
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Swartz AM, Cho CC, Welch WA, Widlansky ME, Maeda H, Strath SJ. Pattern Analysis of Sedentary Behavior Change after a Walking Intervention. Am J Health Behav. 2018 May 1;42(3):90-101. doi: 10.5993/AJHB.42.3.9.
PubMed 29663984Suboc TB, Strath SJ, Dharmashankar K, Coulliard A, Miller N, Wang J, Tanner MJ, Widlansky ME. Relative importance of step count, intensity, and duration on physical activity's impact on vascular structure and function in previously sedentary older adults. J Am Heart Assoc. 2014 Feb 26;3(1):e000702. doi: 10.1161/JAHA.113.000702.
PubMed 24572255
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis
- ClinicalTrials.gov ID
- NCT01212978
- Acronym / sponsor ID
- MCW-MEW2
- Conditions
- Aging, Cardiology, Nitric Oxide
- Keywords
- Aging, Endothelium,Vascular, Arterial Remodeling, Ventricular Vascular Coupling, Nitric Oxide, Walking, Software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 1 Oct 2010 (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 American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from data supporting that regular physical activity reduces the risk of adverse cardiovascular events A portion of these benefits may be from reductions in the incidence and severity of cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.
While this recommendation for physical activity has been in existence for almost 15 years, the rates of obesity in the United States continue to rise and prevalence of sedentarism remains at best unchanged. Researchers have been engaged in investigating novel interventions to designed increase physical activity to reach the recommended activity targets. One promising intervention involves use of inexpensive, easy to use pedometers that allow individuals to objectively track the number of steps taken during a set period of time. Recent data suggest that an average of 10,000 steps/day as measured by a pedometer accurately estimates the activity levels recommended by the AHA, ASCM, and US government public health guidelines.
While the benefits of habitual exercise are well-documented, there are no data that demonstrate current recommendations for moderate physical activity in older adults by the ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events. Interestingly, prior work indicates that pedometer-centered interventions can increase physical activity, suggesting that this type of intervention could potentially lead to cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including brachial artery endothelial function, tonometric measurements of vascular stiffness, and measurements derived from transthoracic echocardiography, we will determine whether increasing the physical activity of sedentary adults to an average of 10,000 steps or more/day translates into improvements in cardiovascular health. This will be determined in the context of a randomized control trial employing a control group, a study group that uses a pedometer alone, and an intervention that couples a pedometer with internet-based motivational messaging software demonstrated in our preliminary data to encourage older adults to reach and exceed the 10,000 steps/day goal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | No intervention | –These subjects will neither receive a pedometer or access to the motivational software until completion of the study. |
| Pedometer only | Active comparator | Behavioral: Pedometer to Increase Physical ActivityParticipants in the this arm will receive a pedometer with instructions to reach a goal of 10,000 steps/day but will not receive access to the motivational software. |
| Pedometer + Motivational Software | Experimental | Behavioral: Pedometer to Increase Physical ActivityIn this arm, subjects will receive access to both a pedometer and motivational software |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 and ≤90 years of age
- Able to Ambulate without an Assist Device
Key exclusion criteria (8 listed)
- History of Uncontrolled Diabetes Mellitus (Type 1 or 2) HgA1C >9.0%
- Uncontrolled hypertension with a blood pressure greater than 160/100 mmHg at the screening visit.
- Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
- Known history of cognitive impairment or inability to follow study procedures
- History of limb amputation other than toes
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 |
|---|---|---|
| Pedometer to Increase Physical ActivityAlso: Omron Pocket PedometerThe pedometer will be given to arms 2 and 3 (pedometer only and pedometer+software intervention) to help them guide their increase in physical activity. | Behavioural | Pedometer + Motivational Software, Pedometer only |
Primary outcome
Flow induced Dilation of the Brachial Artery (FMD%)
Time frame: 12 weeks
2 secondary outcomes
Left Ventricular Systolic Performance
Time frame: 12 weeks
Left Ventricular Diastolic Function
Time frame: 12 weeks
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 28 Feb 2019.
- Derived from this study: PubMed 29663984Swartz AM, Cho CC, Welch WA, Widlansky ME, Maeda H, Strath SJ. Pattern Analysis of Sedentary Behavior Change after a Walking Intervention. Am J Health Behav. 2018 May 1;42(3):90-101. doi: 10.5993/AJHB.42.3.9.
- Derived from this study: PubMed 24572255Suboc TB, Strath SJ, Dharmashankar K, Coulliard A, Miller N, Wang J, Tanner MJ, Widlansky ME. Relative importance of step count, intensity, and duration on physical activity's impact on vascular structure and function in previously sedentary older adults. J Am Heart Assoc. 2014 Feb 26;3(1):e000702. doi: 10.1161/JAHA.113.000702.
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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.
Michael E Widlansky principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer to Increase Physical Activity in people with Aging and Cardiology, run by Medical College of Wisconsin 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 2 inclusion and 8 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 28 Feb 2019. 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.
What does the primary outcome measure?
Flow induced Dilation of the Brachial Artery (FMD%) (time frame: 12 weeks). 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 NCT01212978, which also lists 2 linked publications.
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 28 Feb 2019.