Physical ActivityPhase 2StepCountNCT01158638
Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly
A Phase 2 study testing Web Mediated Step Intervention in people with Physical Activity and Elderly, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Elderly
- What is being tested?
- Web Mediated Step Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2016
- Phase
- Phase 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female individuals living in the community.
- Aged between 50 and 85 years, at screening.
- Sufficient physical function not to have limitations to participate in physical activity demonstrated by:
- Habitual gait speed ≥ 1.5 mph, AND
- No use of a cane or walker, AND
- Able to walk ≥ 50 feet unaided
Show all 9Show fewer
- Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(>23 score).
- Be able to read and write in English
- Sedentary behavior, demonstrated by no regular activity / exercise for previous 6 months and/or a Stage of Change 2 and 3
Who cannot join
- Presence of a rapidly progressive or terminal illness condition that is expected to result in significant functional decline during the course of the proposed studies.
- Significant uncontrolled cardiovascular disease and conditions, e.g. unstable or new onset angina, unrepaired aortic aneurysms, critical aortic stenosis or CAD without bypass, persistent moderate to severe uncontrolled hypertension.
- Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
- Fracture of lower extremity within three months.
- Amputation other than toes.
- Current history of severe arthritis or orthopedic condition precluding physical activity.
- Participation in any regular structured exercise (resistance training, Tai Chi, high intensity walking, jogging, cycling, stair climbing, stepping, within the previous 6 months.
- Individuals that start a new medication that can impact health variables examined during study period (e.g., beta blockers, glucose or cholesterol altering medications), or individuals who alter medication dose that can impact health variables examined within study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity & Health Research Laboratory
Milwaukee, Wisconsin, 53201
About this study
Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly
- Conditions
- Physical Activity, Elderly
- Being tested
- Web Mediated Step Intervention
- Keywords
- Physical Activity Enhancement
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web Mediated Step InterventionBehavioural
The testing of a web mediated step intervention designed to set weekly step targets, and channel participants through a series of motivational screens depending on compliance or non-compliance with set step goals.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care |
| 10,000 Steps Group | Active comparator | Each participant randomized to this study arm will receive a pedometer and a generic recommendation to accumulate 10,000 Steps per Day. Receives: Behavioral: Web Mediated Step Intervention |
| Web Mediated Step Group | Experimental | Participants randomized to this study arm receive an introduction to the study website. Each person utilizes the website to track their daily physical activity steps. Goals are given on a weekly basis to increase steps by 10% per day per week over baseline values. The website channels each participant through a series of motivational messages designed to increase compliance with recommended physical activity targets Receives: Behavioral: Web Mediated Step Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively assessed steps per day
Pedometer determined physical activity
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 posted8 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Scott J. Strath, University of Wisconsin, Milwaukee
- Investigators
- Scott J Strath, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158638
- Sponsor's protocol ID
- StepCount
- Other IDs
- K01AG025962
- Acronym
- StepCount
- Status last verified
- May 2015
- First submitted
- 7 Jul 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly
- ClinicalTrials.gov ID
- NCT01158638
- Acronym / sponsor ID
- StepCount / StepCount
- Conditions
- Physical Activity, Elderly
- Keywords
- Physical Activity Enhancement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2009
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 8 Jul 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.
Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care |
| 10,000 Steps Group | Active comparator | Behavioral: Web Mediated Step InterventionEach participant randomized to this study arm will receive a pedometer and a generic recommendation to accumulate 10,000 Steps per Day. |
| Web Mediated Step Group | Experimental | Behavioral: Web Mediated Step InterventionParticipants randomized to this study arm receive an introduction to the study website. Each person utilizes the website to track their daily physical activity steps. Goals are given on a weekly basis to increase steps by 10% per day per week over baseline values. The website channels each participant through a series of motivational messages designed to increase compliance with recommended physical activity targets |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female individuals living in the community.
- Aged between 50 and 85 years, at screening.
- Sufficient physical function not to have limitations to participate in physical activity demonstrated by:
- Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(>23 score).
- Be able to read and write in English
Key exclusion criteria (8 listed)
- Presence of a rapidly progressive or terminal illness condition that is expected to result in significant functional decline during the course of the proposed studies.
- Significant uncontrolled cardiovascular disease and conditions, e.g. unstable or new onset angina, unrepaired aortic aneurysms, critical aortic stenosis or CAD without bypass, persistent moderate to severe uncontrolled hypertension.
- Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
- Fracture of lower extremity within three months.
- 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 |
|---|---|---|
| Web Mediated Step InterventionThe testing of a web mediated step intervention designed to set weekly step targets, and channel participants through a series of motivational screens depending on compliance or non-compliance with set step goals. | Behavioural | 10,000 Steps Group, Web Mediated Step Group |
Primary outcome
Objectively assessed steps per day
Time frame: 12 weeks
Pedometer determined physical activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Scott J Strath, PhD principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Web Mediated Step Intervention in people with Physical Activity and Elderly, run by University of Wisconsin, Milwaukee 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 9 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: status not confirmed, as of the sponsor's last update on 28 May 2015. 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.
What does this phase mean?
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?
Results are not available in the source record.
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?
Objectively assessed steps per day (time frame: 12 weeks). 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 28 May 2015.