Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults

Coronary Artery Disease Clinical Trial

— AAIMASP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635477
• Other study ID #: AAIM ASP 2015
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2015
• Last updated: February 10, 2017
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: American College of Cardiology
• Contact: Scott Hummell, MD
• Phone: (734) 998-7991
• Email: scothumm[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

1. older adults aged =70 years,

2. at least one criteria positive on the FRAIL scale,

3. hospital discharge to an independent residence,

4. primary final discharge diagnosis of coronary disease or heart failure but not requiring cardiac surgery or TAVR during the index hospitalization,

5. able to stand and walk without assistance from another person,

6. able to carry out basic activities of daily living without assistance as per Clinical Frailty Scale rating =5,

7. signed informed consent from the patients, and

8. approval from the treating physician that the patient is safe and appropriate to participate in this trial.

Exclusion Criteria:

1. cognitive impairment defined by a positive mini-cog test or known moderate or severe dementia,

2. more than one fall in the past six months, or a fall in the past three months prior to hospitalization,

3. high-risk for falls or unsteady for mobilization according to a clinical physical therapist's assessment (if performed) or as assessed during functional testing,

4. non-revascularized acute myocardial infarction within the past month (unless revascularization was not indicated) or uncorrected severe symptomatic aortic stenosis,

5. 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),

6. referral to a structured cardiac rehabilitation program in the first 30 days after hospital discharge (not counting home-based physical therapy),

7. unable to return for follow-up visit, and

8. poor comprehension of the actigraphy device.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Behavioral:
• Intervention
Behavioral: actigraphy device, adaptive step count algorithm
• Control
Behavioral: actigraphy device, step count measurement only

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
United States	Ann Arbor Veterans Affairs	Ann Arbor	Michigan
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Boston Veterans Affairs	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Case Western Reserve University/University Hospital	Cleveland	Ohio
United States	Beaumont Health System/Oakwood	Dearborn	Michigan
United States	Duke University	Durham	North Carolina
United States	New York Presbyterian Hospital/Columbia	New York	New York
United States	New York Presbyterian Hospital/Cornell	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	New Hampshire
United States	University of Washington	Seattle	Washington
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
American College of Cardiology	Alliance for Academic Internal Medicine

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (20)

Afilalo 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. Review. — View Citation

Afilalo 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 — View Citation

Bravata 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. Review. — View Citation

Cyarto EV, Myers A, Tudor-Locke C. Pedometer accuracy in nursing home and community-dwelling older adults. Med Sci Sports Exerc. 2004 Feb;36(2):205-9. — View Citation

Forman 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. — View Citation

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. — View Citation

Gurwitz 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. — View Citation

Hwang 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. Review. — View Citation

Izawa 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 Rehab — View Citation

Izawa KP, Watanabe S, Oka K, Hiraki K, Morio Y, Kasahara Y, Brubaker PH, Osada N, Omiya K, Shimizu H. Usefulness of step counts to predict mortality in Japanese patients with heart failure. Am J Cardiol. 2013 Jun 15;111(12):1767-71. doi: 10.1016/j.amjcard — View Citation

King 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. — View Citation

Leidy NK, Kimel M, Ajagbe L, Kim K, Hamilton A, Becker K. Designing trials of behavioral interventions to increase physical activity in patients with COPD: insights from the chronic disease literature. Respir Med. 2014 Mar;108(3):472-81. doi: 10.1016/j.rm — View Citation

Lindman 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. Review. — View Citation

Martin 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. — View Citation

Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. — View Citation

Riegel 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 Counci — View Citation

Savage 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. — View Citation

Studenski 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. JA — View Citation

Tierney 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. — View Citation

Vaes AW, Cheung A, Atakhorrami M, Groenen MT, Amft O, Franssen FM, Wouters EF, Spruit MA. Effect of 'activity monitor-based' counseling on physical activity and health-related outcomes in patients with chronic diseases: A systematic review and meta-analys — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Quality of life	A secondary outcome for this study is quality of life, as determined by score on the EQ-5D questionnaire	baseline, 30 days
Secondary	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.	baseline, 30 days