Coronary Artery DiseaseAAIMASPNCT02635477
Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults
A study testing Intervention in people with Coronary Artery Disease and Heart Failure, run by American College of Cardiology at 16 sites in 2 countries.
Trial summary
A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Heart Failure
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Jan 2016to Nov 2017
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- older adults aged ≥70 years,
- at least one criteria positive on the FRAIL scale,
- hospital discharge to an independent residence,
- primary final discharge diagnosis of coronary disease or heart failure but not requiring cardiac surgery or TAVR during the index hospitalization,
- able to stand and walk without assistance from another person,
- able to carry out basic activities of daily living without assistance as per Clinical Frailty Scale rating ≤5,
- signed informed consent from the patients, and
- approval from the treating physician that the patient is safe and appropriate to participate in this trial.
Who cannot join
- cognitive impairment defined by a positive mini-cog test or known moderate or severe dementia,
- more than one fall in the past six months, or a fall in the past three months prior to hospitalization,
- high-risk for falls or unsteady for mobilization according to a clinical physical therapist's assessment (if performed) or as assessed during functional testing,
- non-revascularized acute myocardial infarction within the past month (unless revascularization was not indicated) or uncorrected severe symptomatic aortic stenosis,
- active severe symptoms of angina, dyspnea, or claudication at rest or with minimal activity (Canadian Cardiovascular Society class 4, New York Heart Association class 4, or Fontaine class 3-4, respectively),
- referral to a structured cardiac rehabilitation program in the first 30 days after hospital discharge (not counting home-based physical therapy),
- unable to return for follow-up visit, and
- poor comprehension of the actigraphy device.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Ann Arbor Veterans Affairs
Ann Arbor, Michigan
Scott Hummel, MD, scothumm@med.umich.edu
Craig Albert, MD
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan
Scott Hummell, MD, scothumm@med.umich.edu
Craig Alpert, MD
- Recruiting
Emory University
Atlanta, Georgia
Nanette Wenger, MD, nwenger@emory.edu
Jane Titternington, MD
- Recruiting
Boston Veterans Affairs
Boston, Massachusetts
Ariela Orkaby, MD, AORKABY@PARTNERS.ORG
Ariela Orkaby, MD
- Recruiting
University of North Carolina
Chapel Hill, North Carolina
Xuming Dai, MD, xuming_dai@med.unc.edu
Xuming Dai, MD
- Recruiting
Case Western Reserve University/University Hospital
Cleveland, Ohio
Richard Josephson, MD
Ahmad Younes, MD
- Recruiting
Beaumont Health System/Oakwood
Dearborn, Michigan
David Sengstock, MD
David Sengstock, MD
- Recruiting
Duke University
Durham, North Carolina
Karen Alexander, MD
Karen Alexander, MD
- Recruiting
New York Presbyterian Hospital/Columbia
New York, New York
Philip Green, MD, pg2336@cumc.columbia.edu
Philip Green, MD
- Recruiting
New York Presbyterian Hospital/Cornell
New York, New York
Evelyn Horn, MD
Evelyn Horn, MD
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania
Daniel Forman, MD, formand@pitt.edu
Daniel Forman, MD
- Recruiting
Mayo Clinic
Rochester, New Hampshire
Jorge Brenes-Salazar, MD, brenessalazar.jorge@mayo.edu
Jorge Brenes-Salazar, MD
- Recruiting
University of Washington
Seattle, Washington
Michael Chen, MD, michen@u.washington.edu
Michael Chen, MD
- Recruiting
St. Joseph Mercy Hospital
Ypsilanti, Michigan
Marlo Leonen, MD, mleonen@michiganheart.com
Marlo Leonen, MD
Canada2 sites, 2 recruiting
- Recruiting
McGill University
Montreal, Quebec
Christos Galatas, MD, christos.galatas@mail.mcgill.ca
Jonanthan Afilalo, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Marc Jolicoeur, MD, jplicoeur@gmail.com
Maxime Tremblay-Gravel, MD
About this study
Official title: Get Going: Fellow-Led Trial of an Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults Transitioning From a Cardiovascular Hospitalization to Home
A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.
Read the detailed description
The transition from hospital to home is critical for older patients after a cardiovascular hospitalization, since 1 in 3 will suffer the fate of functional decline or repeat hospitalizations within the first 30 days. This has a tremendous impact on the patient, leading to a vicious cycle of worsening health status and disability, and the healthcare system, leading to an estimated $12 billion of preventable costs. At the policy level, preventing readmissions has become a national priority at the forefront of the medical agenda.
Frailty, a geriatric syndrome characterized by subclinical impairments in multiple organs and decreased physiologic resiliency, is a major risk factor for unsuccessful transitions of care and adverse health outcomes. Thus, it has been suggested that interventions aimed at improving transitions of care should target frail patients. Frail individuals demonstrate a well-defined phenotype of muscle weakness and physical inactivity, readily measurable using various scales and instruments. To date, the most widely studied intervention to improve frailty and related outcomes has been physical activity.
However, fewer than 50% of patients adhere to regular physical activity programs. Enrollment in cardiac rehabilitation programs is even lower owing to multiple barriers, including lack of payer reimbursement ≤ 30 days after a hospitalization, the highest risk period for readmissions. Scientific statements have called for augmented "self-care" to assure adequate physical activity in patients with heart failure and other forms of cardiovascular disease 10. Moreover, low-intensity home-based physical activity programs can be as efficacious as higher-intensity center-based programs, strengthening the rationale for self-care.
The advent of small, portable, inexpensive accelerometer devices has emerged as a powerful tool to facilitate self-monitored physical activity. These devices are worn by patients and provide real-time feedback about the number of steps walked each day (as well as other functional parameters). This is in tune with a systematic review which found that feedback and goal setting improved adherence to physical activity in patients with heart failure. A few studies in the physical therapist literature have used accelerometers to demonstrate low baseline physical activity and boost total step counts in patients attending cardiac rehabilitation, but these patients were at least 30 days removed from their index hospitalization, and none enrolled patients in the critical post-discharge phase.
Research question: Is a portable actigraphy-based intervention more effective than standard-of-care in promoting physical activity in the first 30 days after hospital discharge among frail older adults with cardiovascular disease?
- Conditions
- Coronary Artery Disease, Heart Failure
- Being tested
- Intervention, Control
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Behavioral: actigraphy device, adaptive step count algorithm
ControlBehavioural
Behavioral: actigraphy device, step count measurement only
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | frail elderly patients discharged from a cardiovascular hospitalization; provided with an actigraphy device that displays an adaptive personalized daily step count goal and audible alerts to increase physical activity Receives: Behavioral: Intervention |
| Control Group | Experimental | frail elderly patients discharged from a cardiovascular hospitalization; provided with a matching actigraphy device that has a blacked-out screen and does not display step count goals or provide audible alerts (functions in silent monitoring mode only) Receives: Behavioral: Intervention; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps taken per day
The primary outcome measure for this study is the average number of steps walked per day during the study period (excluding the run-in phase), as determined by the actigraphy device.
Measured: 1 year
Secondary outcomes (2)
Quality of life
A secondary outcome for this study is quality of life, as determined by score on the EQ-5D questionnaire
Measured: baseline, 30 days
Short physical performance battery
A secondary outcome for this study is physical performance, as determined by the change in Short Physical Performance Battery score from baseline to 30-days.
Measured: baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Academic Internal Medicine
- Responsible party
- Sponsor
- Investigators
- Scott Hummel, MD, Principal investigator, University of Michigan Ann Arbor, Michigan, USAJonathan Afilalo, MD, MSc, Principal investigator, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635477
- Sponsor's protocol ID
- AAIM ASP 2015
- Acronym
- AAIMASP
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2015
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goldwater DS. Geriatric cardiology: a fellow's perspective. J Am Coll Cardiol. 2014 Sep 30;64(13):1401-3. doi: 10.1016/j.jacc.2014.08.009. No abstract available.
PubMed 25257643Martin SS, Ou FS, Newby LK, Sutton V, Adams P, Felker GM, Wang TY. Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. J Am Coll Cardiol. 2013 Feb 19;61(7):762-9. doi: 10.1016/j.jacc.2012.10.046.
PubMed 23410547Gurwitz JH. The exclusion of older people from participation in cardiovascular trials. Virtual Mentor. 2014 May 1;16(5):365-8. doi: 10.1001/virtualmentor.2014.16.05.pfor1-1405. No abstract available.
PubMed 24847706Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.
PubMed 21050978Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
PubMed 21205966Lindman BR, Alexander KP, O'Gara PT, Afilalo J. Futility, benefit, and transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014 Jul;7(7):707-16. doi: 10.1016/j.jcin.2014.01.167. Epub 2014 Jun 18.
PubMed 24954571Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.
PubMed 24291279Forman DE, Rich MW, Alexander KP, Zieman S, Maurer MS, Najjar SS, Cleveland JC Jr, Krumholz HM, Wenger NK. Cardiac care for older adults. Time for a new paradigm. J Am Coll Cardiol. 2011 May 3;57(18):1801-10. doi: 10.1016/j.jacc.2011.02.014. No abstract available.
PubMed 21527153Riegel B, Moser DK, Anker SD, Appel LJ, Dunbar SB, Grady KL, Gurvitz MZ, Havranek EP, Lee CS, Lindenfeld J, Peterson PN, Pressler SJ, Schocken DD, Whellan DJ; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research. State of the science: promoting self-care in persons with heart failure: a scientific statement from the American Heart Association. Circulation. 2009 Sep 22;120(12):1141-63. doi: 10.1161/CIRCULATIONAHA.109.192628. Epub 2009 Aug 31. No abstract available.
PubMed 19720935King AC, Haskell WL, Taylor CB, Kraemer HC, DeBusk RF. Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial. JAMA. 1991 Sep 18;266(11):1535-42.
PubMed 1880885Hwang R, Marwick T. Efficacy of home-based exercise programmes for people with chronic heart failure: a meta-analysis. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):527-35. doi: 10.1097/HJR.0b013e32832e097f.
PubMed 20054288Tierney S, Mamas M, Woods S, Rutter MK, Gibson M, Neyses L, Deaton C. What strategies are effective for exercise adherence in heart failure? A systematic review of controlled studies. Heart Fail Rev. 2012 Jan;17(1):107-15. doi: 10.1007/s10741-011-9252-4.
PubMed 21567221Savage PD, Ades PA. Pedometer step counts predict cardiac risk factors at entry to cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):370-7; quiz 378-9. doi: 10.1097/HCR.0b013e31818c3b6d.
PubMed 19008690Izawa KP, Watanabe S, Hiraki K, Morio Y, Kasahara Y, Takeichi N, Oka K, Osada N, Omiya K. Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Nov;93(11):1896-902. doi: 10.1016/j.apmr.2012.06.015. Epub 2012 Jun 28.
PubMed 22750166Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
PubMed 18029834
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Going: Fellow-Led Trial of an Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults Transitioning From a Cardiovascular Hospitalization to Home
- ClinicalTrials.gov ID
- NCT02635477
- Acronym / sponsor ID
- AAIMASP / AAIM ASP 2015
- Conditions
- Coronary Artery Disease, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- American College of CardiologyUniversity, hospital or other
- Collaborators
- Alliance for Academic Internal Medicine
- Study start
- Jan 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 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.
A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.
Detailed description
The transition from hospital to home is critical for older patients after a cardiovascular hospitalization, since 1 in 3 will suffer the fate of functional decline or repeat hospitalizations within the first 30 days. This has a tremendous impact on the patient, leading to a vicious cycle of worsening health status and disability, and the healthcare system, leading to an estimated $12 billion of preventable costs. At the policy level, preventing readmissions has become a national priority at the forefront of the medical agenda.
Frailty, a geriatric syndrome characterized by subclinical impairments in multiple organs and decreased physiologic resiliency, is a major risk factor for unsuccessful transitions of care and adverse health outcomes. Thus, it has been suggested that interventions aimed at improving transitions of care should target frail patients. Frail individuals demonstrate a well-defined phenotype of muscle weakness and physical inactivity, readily measurable using various scales and instruments. To date, the most widely studied intervention to improve frailty and related outcomes has been physical activity.
However, fewer than 50% of patients adhere to regular physical activity programs. Enrollment in cardiac rehabilitation programs is even lower owing to multiple barriers, including lack of payer reimbursement ≤ 30 days after a hospitalization, the highest risk period for readmissions. Scientific statements have called for augmented "self-care" to assure adequate physical activity in patients with heart failure and other forms of cardiovascular disease 10. Moreover, low-intensity home-based physical activity programs can be as efficacious as higher-intensity center-based programs, strengthening the rationale for self-care.
The advent of small, portable, inexpensive accelerometer devices has emerged as a powerful tool to facilitate self-monitored physical activity. These devices are worn by patients and provide real-time feedback about the number of steps walked each day (as well as other functional parameters). This is in tune with a systematic review which found that feedback and goal setting improved adherence to physical activity in patients with heart failure. A few studies in the physical therapist literature have used accelerometers to demonstrate low baseline physical activity and boost total step counts in patients attending cardiac rehabilitation, but these patients were at least 30 days removed from their index hospitalization, and none enrolled patients in the critical post-discharge phase.
Research question: Is a portable actigraphy-based intervention more effective than standard-of-care in promoting physical activity in the first 30 days after hospital discharge among frail older adults with cardiovascular disease?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Interventionfrail elderly patients discharged from a cardiovascular hospitalization; provided with an actigraphy device that displays an adaptive personalized daily step count goal and audible alerts to increase physical activity |
| Control Group | Experimental | Behavioral: Intervention, Behavioral: Controlfrail elderly patients discharged from a cardiovascular hospitalization; provided with a matching actigraphy device that has a blacked-out screen and does not display step count goals or provide audible alerts (functions in silent monitoring mode only) |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- older adults aged ≥70 years,
- at least one criteria positive on the FRAIL scale,
- hospital discharge to an independent residence,
- primary final discharge diagnosis of coronary disease or heart failure but not requiring cardiac surgery or TAVR during the index hospitalization,
- able to stand and walk without assistance from another person,
Key exclusion criteria (8 listed)
- cognitive impairment defined by a positive mini-cog test or known moderate or severe dementia,
- more than one fall in the past six months, or a fall in the past three months prior to hospitalization,
- high-risk for falls or unsteady for mobilization according to a clinical physical therapist's assessment (if performed) or as assessed during functional testing,
- non-revascularized acute myocardial infarction within the past month (unless revascularization was not indicated) or uncorrected severe symptomatic aortic stenosis,
- active severe symptoms of angina, dyspnea, or claudication at rest or with minimal activity (Canadian Cardiovascular Society class 4, New York Heart Association class 4, or Fontaine class 3-4, respectively),
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 |
|---|---|---|
| InterventionBehavioral: actigraphy device, adaptive step count algorithm | Behavioural | Control Group, Intervention Group |
| ControlBehavioral: actigraphy device, step count measurement only | Behavioural | Control Group |
Primary outcome
Steps taken per day
Time frame: 1 year
The primary outcome measure for this study is the average number of steps walked per day during the study period (excluding the run-in phase), as determined by the actigraphy device.
2 secondary outcomes
Quality of life
Time frame: baseline, 30 days
Short physical performance battery
Time frame: baseline, 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Results publication: PubMed 25257643Goldwater DS. Geriatric cardiology: a fellow's perspective. J Am Coll Cardiol. 2014 Sep 30;64(13):1401-3. doi: 10.1016/j.jacc.2014.08.009. No abstract available.
- Results publication: PubMed 23410547Martin SS, Ou FS, Newby LK, Sutton V, Adams P, Felker GM, Wang TY. Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. J Am Coll Cardiol. 2013 Feb 19;61(7):762-9. doi: 10.1016/j.jacc.2012.10.046.
- Results publication: PubMed 24847706Gurwitz JH. The exclusion of older people from participation in cardiovascular trials. Virtual Mentor. 2014 May 1;16(5):365-8. doi: 10.1001/virtualmentor.2014.16.05.pfor1-1405. No abstract available.
- Results publication: PubMed 21050978Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.
- Results publication: PubMed 21205966Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- Results publication: PubMed 24954571Lindman BR, Alexander KP, O'Gara PT, Afilalo J. Futility, benefit, and transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014 Jul;7(7):707-16. doi: 10.1016/j.jcin.2014.01.167. Epub 2014 Jun 18.
- Results publication: PubMed 24291279Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.
- Results publication: PubMed 21527153Forman DE, Rich MW, Alexander KP, Zieman S, Maurer MS, Najjar SS, Cleveland JC Jr, Krumholz HM, Wenger NK. Cardiac care for older adults. Time for a new paradigm. J Am Coll Cardiol. 2011 May 3;57(18):1801-10. doi: 10.1016/j.jacc.2011.02.014. No abstract available.
- Results publication: PubMed 19720935Riegel B, Moser DK, Anker SD, Appel LJ, Dunbar SB, Grady KL, Gurvitz MZ, Havranek EP, Lee CS, Lindenfeld J, Peterson PN, Pressler SJ, Schocken DD, Whellan DJ; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research. State of the science: promoting self-care in persons with heart failure: a scientific statement from the American Heart Association. Circulation. 2009 Sep 22;120(12):1141-63. doi: 10.1161/CIRCULATIONAHA.109.192628. Epub 2009 Aug 31. No abstract available.
- Results publication: PubMed 1880885King AC, Haskell WL, Taylor CB, Kraemer HC, DeBusk RF. Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial. JAMA. 1991 Sep 18;266(11):1535-42.
- Results publication: PubMed 20054288Hwang R, Marwick T. Efficacy of home-based exercise programmes for people with chronic heart failure: a meta-analysis. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):527-35. doi: 10.1097/HJR.0b013e32832e097f.
- Results publication: PubMed 21567221Tierney S, Mamas M, Woods S, Rutter MK, Gibson M, Neyses L, Deaton C. What strategies are effective for exercise adherence in heart failure? A systematic review of controlled studies. Heart Fail Rev. 2012 Jan;17(1):107-15. doi: 10.1007/s10741-011-9252-4.
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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 Hummel, MD principal investigator
University of Michigan Ann Arbor, Michigan, USA
Jonathan Afilalo, MD, MSc principal investigator
Jewish General Hospital, McGill University, Montreal, Quebec, Canada
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Coronary Artery Disease and Heart Failure, run by American College of Cardiology at 16 sites in 2 countries.
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 8 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Hummell, MD ((734) 998-7991, scothumm@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps taken per day (time frame: 1 year). 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 NCT02635477, which also lists 20 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 13 Feb 2017.