Long-term Exercise in Older Cardiac Patients

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

Interventions

BEHAVIORAL

SystemCHANGE

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.

BEHAVIORAL

CHANGE+

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.

BEHAVIORAL

Usual Care

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.

Sponsors & Collaborators

• Case Western Reserve University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2010-06-30

Completion

2010-06-30