Cardiovascular DiseasesNCT02632487
Wearable Technology to Reduce Sedentary Behavior and CVD Risk in Older Adults
A study testing Exercise and Non-Exercise Physical Activity (NEPA) in people with Cardiovascular Diseases, run by University of Florida at 1 site in United States.
Trial summary
This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Exercise and Non-Exercise Physical Activity (NEPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 20 Nov 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity by CHAMPS questionnaire
- Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
- Willingness to be randomized to either intervention group
- Willingness to participate in all study procedures
Who cannot join
- Failure to provide informed consent;
- Regular participation in an exercise training program within the last 3 months
- Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
- Office SBP > 180 mm Hg or DBP > 110 mm Hg
- Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
- Myocardial infarction or stroke within past year
Show all 13Show fewer
- Significant cognitive impairment, i.e. known dementia or a Mini-Mental State Examination score < 24
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS;
- Severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
- Other significant co-morbid conditions that would impair ability to participate in the intervention
- Simultaneous participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Clinical Translational Research Building
Gainesville, Florida, 32611
About this study
This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).
Read the detailed description
A recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks. Participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (EX) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase NEPA within their daily routines (EX + NEPA). Evaluations will be done to 1) the extent to which EX + NEPA modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.
- Conditions
- Cardiovascular Diseases
- Being tested
- Exercise, Non-Exercise Physical Activity (NEPA)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Center-based walking + balance, stretching, and light resistance
Non-Exercise Physical Activity (NEPA)Behavioural
Behavioral counseling paired with technology intervention to monitor physical activity
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | This group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active. Receives: Behavioral: Exercise |
| Exercise + Non-Exercise Physical Activity (NEPA) | Experimental | This group will receive 8 weeks of center-based exercise combined with behavioral counseling and a technology intervention designed to increase daily Exercise + Non-Exercise Physical Activity (NEPA). Receives: Behavioral: Exercise; Behavioral: Non-Exercise Physical Activity (NEPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure between the groups
Measured: 20 weeks
Secondary outcomes (2)
Exercise capacity between the groups
distance on 6-minute walk test
Measured: 20 weeks
Waist circumference between the groups
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completion20 Nov 2018
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 University of FloridaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Stephen Anton, Principal investigator, Univesity of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632487
- Sponsor's protocol ID
- IRB201501139
- Status last verified
- Nov 2018
- First submitted
- 14 Dec 2015
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Technology to Reduce Sedentary Behavior and CVD Risk in Older Adults
- ClinicalTrials.gov ID
- NCT02632487
- Acronym / sponsor ID
- IRB201501139
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 16 Dec 2015 (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.
This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).
Detailed description
A recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks. Participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (EX) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase NEPA within their daily routines (EX + NEPA). Evaluations will be done to 1) the extent to which EX + NEPA modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: ExerciseThis group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active. |
| Exercise + Non-Exercise Physical Activity (NEPA) | Experimental | Behavioral: Exercise, Behavioral: Non-Exercise Physical Activity (NEPA)This group will receive 8 weeks of center-based exercise combined with behavioral counseling and a technology intervention designed to increase daily Exercise + Non-Exercise Physical Activity (NEPA). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity by CHAMPS questionnaire
- Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
- Willingness to be randomized to either intervention group
- Willingness to participate in all study procedures
Key exclusion criteria (13 listed)
- Failure to provide informed consent;
- Regular participation in an exercise training program within the last 3 months
- Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
- Office SBP > 180 mm Hg or DBP > 110 mm Hg
- Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
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 |
|---|---|---|
| ExerciseCenter-based walking + balance, stretching, and light resistance | Behavioural | Exercise, Exercise + Non-Exercise Physical Activity (NEPA) |
| Non-Exercise Physical Activity (NEPA)Behavioral counseling paired with technology intervention to monitor physical activity | Behavioural | Exercise + Non-Exercise Physical Activity (NEPA) |
Primary outcome
Blood pressure between the groups
Time frame: 20 weeks
2 secondary outcomes
Exercise capacity between the groups
Time frame: 20 weeks
Waist circumference between the groups
Time frame: 20 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 23 Nov 2018.
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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.
Stephen Anton principal investigator
Univesity of Florida
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 and Non-Exercise Physical Activity (NEPA) in people with Cardiovascular Diseases, run by University of Florida 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 13 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 23 Nov 2018. 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?
Blood pressure between the groups (time frame: 20 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 23 Nov 2018.