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临床试验/NCT02323919
NCT02323919已完成不适用

Improving Long Term Exercise in Older Cardiac Patients

Case Western Reserve University0 个研究点目标入组 379 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
379
主要终点
Objectively measured hours of exercise/month

研究概览

简要总结

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.

详细描述

Assisting individuals to adopt and maintain lifestyle exercise after a cardiac event remains challenging. The purpose of this 3-group, randomized controlled trial was to test two theoretically distinct behavior change interventions against a usual care (UC) group to increase lifestyle exercise after a cardiac event. In a new intervention, SystemCHANGE (SC), based on process improvement and ecological theories, participants were taught to use a series of small self-designed experiments to change their daily routines associated with exercise. The emphasis was on changing systems in their lives rather than relying on motivation or memory. The second intervention, CHANGE+ (C+), based on cognitive behavioral theory, included contemporary approaches to increase self-efficacy, motivation, and problem-solving skills.

Sample

The sample consisted of a convenience sample of 379 individuals who were consecutively recruited from five Phase II cardiac rehabilitation programs (CRP) in the greater Cleveland, Ohio area. Forty percent of the participants approached agreed to participate and were randomized. Of the 406 subjects consented, 379 completed the study. Subjects were randomly assigned to one of three study arms: SystemCHANGE (process improvement model program of health behavior change), CHANGE+ (cognitive behavioral model program of health behavior change), or Usual Care. All subjects had a recent cardiac event (myocardial infarction, coronary artery bypass surgery and/or percutaneous coronary intervention) and were participating in a Phase II cardiac rehabilitation program. Subjects were recruited near the end of their program and followed for one year after cardiac rehabilitation. Subjects were included if they were greater than 55 years of age and able to read and speak English; they were excluded if they met criteria for being at high risk for safe exercise participation following a cardiac event (ejection fraction < 30%, decrease in systolic blood pressure of > 15 mmHg with exercise, serious arrhythmias at rest or exercise induced, and exercise induced ischemia indicated by angina > 2 mm ST segment depression on the electrocardiogram).

Intervention Protocols

Both the CHANGE+ and SystemCHANGE interventions consist 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. Usual Care consisted of only the routine care provided at the CRP. All participants received the usual CRP prescribed structured exercise and individual and group classes (four) on diet modification and stress reduction that are part of routine care at the CRPs. At the end of the CRP, all individuals were given an exercise prescription that included their target heart rate and counseled to exercise at least five times a week for 30 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 55 years and older
  • myocardial infarction
  • 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.

排除标准

  • 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.

结局指标

主要结局

Objectively measured hours of exercise/month

时间窗: study months 1-13

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shirley Moore

Professor and Associate Dean

Case Western Reserve University

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