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Coronary Artery DiseaseNCT02323919

Long-term Exercise in Older Cardiac Patients

A study testing SystemCHANGE and CHANGE+ in people with Coronary Artery Disease, run by Case Western Reserve University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
SystemCHANGE and CHANGE+
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
379 participants
Where
No sites listed yet
Study dates
Apr 2006to Jun 2010
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.

About this study

Official title: Improving Long Term Exercise in Older Cardiac Patients

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.

Read the detailed description

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.

Measures

Three dimensions of exercise were measured: frequency, amount, and maintenance. Exercise frequency was the number of sessions exercised (of at least 10 minutes duration) over a given period of time. Exercise amount was the number of hours exercised and reflected both the frequency and the duration of each exercise session. Exercise was measured using portable wristwatch heart rate monitors (Polar RS400) and exercise diaries. Data from the monitors was used as the primary data source with diary data used as backup if data from the monitor were not available (i.e., forgot to put on the monitor, monitor malfunction). The heart rate (HR) monitor memory was programmed to record HR at 5-second intervals during an exercise session. Standardized, validated measures were also obtained at baseline, two, six, and twelve months of: system changes, social support for exercise, problem-solving skills, motivation, health beliefs, and exercise self-efficacy. Measures were also obtained on possible moderating and confounding variables: age, race, functional capacity, body fat, co-morbidity, muscle or joint pain, exercise experience, home and neighborhood environment, and depression.

Procedures

Individuals who met study inclusion criteria were enrolled during the sixth to eighth week of the CRP and written informed consent was obtained. Baseline measures were obtained in a private interview at the CRP center. The intervention began week ten of the subjects' CRP. At the end of their CRP, subjects were given HR monitors and exercise diaries and were directed to return mail them during each of the next twelve months. The number of hours exercised during exercise adoption (months one through three) and maintenance (months four through twelve) was calculated. Multiple linear regression was used to determine if study group membership predicted exercise adoption and maintenance. Mediation analysis was also conducted.

Being tested
SystemCHANGE, CHANGE+, Usual Care
Keywords
myocardial infarction, coronary artery bypass graft (CABG), angioplasty, exercise, cardiac patient, physical activity
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SystemCHANGEBehavioural

    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+Behavioural

    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.

  • Usual CareBehavioural

    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.

Study groups in NCT02323919
Study groupRoleWhat they receive
SystemCHANGEActive comparatorconsists of self-efficacy enhancement and relapse prevention strategies, but is primarily anchored in a set of behavior change strategies based on System Improvement techniques.
Receives: Behavioral: CHANGE+
CHANGE+Active comparatoris based on several cognitive-behavioral theoretical frameworks: Social Problem-solving Model, Self-efficacy theory, Expectancy-value theory and Relapse Prevention theory.
Receives: Behavioral: SystemCHANGE
Usual CarePlacebo comparatorUsual Care
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objectively measured hours of exercise/month

    Measured: study months 1-13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study startApr 2006
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323919
Sponsor's protocol ID
HL084767
Status last verified
Jan 2016
First submitted
16 Dec 2014
Last updated
27 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing SystemCHANGE and CHANGE+ in people with Coronary Artery Disease, run by Case Western Reserve University.

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 6 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objectively measured hours of exercise/month (time frame: study months 1-13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jan 2016.

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Long-term Exercise in Older Cardiac Patients | AzTrials