Long-term Exercise in Older Cardiac Patients

NCT02323919 | Completed DMC

• 1 other identifier: HL084767
• Study Type: interventional
• Target: 379
• Locations: 0 countries
• Sites: N/A

Brief Summary

Using a randomized clinical trial with 3 groups, the investigators will conduct a head-to-head evaluation of two different theoretically-based interventions, SystemCHANGE and CHANGE+, as compared to Usual Care to improve the adoption and maintenance of exercise in older cardiac patients. SystemCHANGE, a novel intervention that focuses on environmental change uses System Improvement strategies to increase exercise, will be compared to CHANGE+ (an intervention based contemporary cognitive behavioral strategies). Study questions are: (1) Is there a difference between SystemCHANGE, CHANGE+ and Usual Care in exercise adoption when controlling for covariates (age, race, functional capacity, body fat, co-morbidity, muscle or joint pain, exercise experience, home and neighborhood environment, and depression), for individuals following a cardiac rehabilitation program (CRP)? (2) Is there a difference between SystemCHANGE, CHANGE+, and Usual Care in exercise maintenance when controlling for covariates? (3) Do system changes, social support for exercise, problem-solving skills, motivation, health beliefs, and exercise self-efficacy mediate the effects of SystemCHANGE, CHANGE+, or Usual Care on exercise adoption? (4) Do system changes, social support for exercise, problem-solving skills, motivation, health beliefs, and exercise self-efficacy mediate the effects of SystemCHANGE, CHANGE+ and CHANGE+ interventions in terms of health care spending, labor force participation and earnings, and household productivity? Older persons (N=420) recovering from cardiac events will be randomly assigned to the three groups. Measures of exercise adoption and maintenance (# of metabolic equivalents {METS} expended, and whether or not a subject remains exercising) will be taken for 1 year after completion of a CRP using heart rate wristwatch monitors, exercise diaries, and 7-Day Recall Survey. The effect of covariates also will be assessed. Mechanisms by which the interventions achieve their effects will be determined. Multivariate analyses will examine and compare the effects of the interventions over time. A cost-effectiveness analysis also will be conducted.

Conditions

Coronary Artery Disease

Keywords

myocardial infarction; coronary artery bypass graft (CABG); angioplasty; exercise; cardiac patient; physical activity

Outcome Measures

Primary Outcomes (1)

• Objectively measured hours of exercise/month

  study months 1-13

Study Arms (3)

SystemCHANGE

ACTIVE COMPARATOR

consists of self-efficacy enhancement and relapse prevention strategies, but is primarily anchored in a set of behavior change strategies based on System Improvement techniques.

Behavioral: CHANGE+

CHANGE+

ACTIVE COMPARATOR

is based on several cognitive-behavioral theoretical frameworks: Social Problem-solving Model, Self-efficacy theory, Expectancy-value theory and Relapse Prevention theory.

Behavioral: SystemCHANGE

Usual Care

PLACEBO COMPARATOR

Usual Care

Behavioral: Usual Care

Interventions

SystemCHANGE BEHAVIORAL

consists of a series of five small-group (six to eight people) education sessions provided in three 1.5 -hour sessions once a week during the last three weeks of the CRP and in two sessions held at one and two months following completion of their CRP. An experienced cardiac nurse or exercise physiologist trained in the intervention protocol taught each of the sessions. In a series of structured activities, participants were taught to use behavior change strategies consistent with the respective intervention models. A series of three monthly booster calls were made during months four, five and six following the last intervention class and individuals were coached in the use of strategies consistent with the respective interventions.

CHANGE+

CHANGE+ BEHAVIORAL

consists of a series of five small-group (six to eight people) education sessions provided in three 1.5 -hour sessions once a week during the last three weeks of the CRP and in two sessions held at one and two months following completion of their CRP. An experienced cardiac nurse or exercise physiologist trained in the intervention protocol taught each of the sessions. In a series of structured activities, participants were taught to use behavior change strategies consistent with the respective intervention models. A series of three monthly booster calls were made during months four, five and six following the last intervention class and individuals were coached in the use of strategies consistent with the respective interventions.

SystemCHANGE

Usual Care BEHAVIORAL

Participants will receive only the routine care provided to CRP patients. This care consists of assessment of exercise capacity, graduated exercise training (consisting of exercising three times a week at the cardiac rehabilitation center on treadmill or cycle, counseling about safe exercise {warm-up procedures, pulse taking, attending to body cues for exertion levels} and advisement to exercise on days between CRP sessions). At the end of the CRP, individuals are given an exercise prescription that includes their target heart rate and they are counseled to exercise at least 5 times a week for 30 minutes. This information is provided by the CRP personnel, usually in the form of individual informal conversations during exercise at the CRP.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 55 years and older
• myocardial infarction
• CABG
• percutaneous transluminal coronary angiography (PTCA)
• completing a Phase II cardiac rehabilitation program
• all patients will be approved for the ability to safely perform exercise by the cardiac rehabilitation program prior to entrance into the study.

You may not qualify if:

• children
• non-English speaking
• current valve surgery
• presences of neurological deficits
• renal (acute renal failure) or pulmonary complications (pneumonia, severe congestive heart failure)
• obvious musculoskeletal functional disabilities
• patients displaying any of the following cardiac characteristics at the time of discharge from the hospital also will be excluded:
• severe left ventricular dysfunction (ejection fraction \<20%)
• decrease in systolic blood pressure \>15 mmHg with exercise
• serious arrhythmias at rest or exercise induced, and (4) exercise-induced ischemia indicated by angina\> 2 mm of ST depression on the ECG, if they met criteria for being at high risk for safe exercise participation following a cardiac event.

Sponsors & Collaborators

• Case Western Reserve University: lead

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 24, 2014
• Study Start: April 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 27, 2016

Record last verified: 2016-01