Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

Not Applicable

Completed

• Conditions: Weight Loss; Obesity; CHD - Coronary Heart Disease
• Interventions: Other: Exercise; Behavioral: Health Education; Other: Exercise Compliance; Other: Dietary Counseling; Dietary Supplement: Calorie-Restricted Diet; Behavioral: Behavioral Modification; Other: Weight-Loss Compliance

• Registration Number: NCT03423238
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard of care fails to implement evidence-based obesity treatment for this high-risk population. Multiple lines of evidence suggest that weight loss improves outcomes in CHD patients. The primary goal of this study is to determine the feasibility of adding a 6-month behavioral weight loss intervention to exercise-based cardiac rehabilitation.

Detailed Description

Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard of care fails to implement evidence-based obesity treatment for this high-risk population. The efficacy of exercise-based cardiac rehabilitation for improving exercise capacity and CHD risk factors is markedly blunted in CHD patients with obesity. Current programs largely focus on nutrient intake and produce minimal weight loss, on average. Our data show that despite appropriate exercise prescription and adherence, only 22% of CHD patients with obesity lose even the minimum recommended body weight over a 3-month program. These findings indicate that targeting reductions in caloric intake is needed to optimize outcomes in these patients and suggest that current programs are too short to produce adequate weight loss and ensure the necessary behavioral adaptations for long-term maintenance. Randomization to diet-induced weight loss in combination with aerobic exercise improves exercise capacity, quality of life, and CHD risk factors more than exercise alone and reduces long-term mortality in overweight and obese adults. The primary goal of this study is to determine the feasibility of adding a 6-month behavioral weight loss intervention to exercise-based cardiac rehabilitation.

Study Timeline

• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-06
• Study Start: 2018-03-21
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Results First Submitted: 2021-07-29
• Status Verified: 2021-09
• Results First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Results First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• documented CHD defined as hospitalization for MI/heart attack coronary artery bypass grafting (CABG) or percutaneous coronary intervention (i.e., angioplasty, stent)
• age = 40 and older
• overweight or obese based on an elevated BMI (≥25 kg/m2)

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Exclusion Criteria

• body weight >450 lbs
• congestive heart failure (ejection fraction <35%)
• advanced kidney disease (on dialysis, or dialysis anticipated within 6 months)
• cognitive impairment (Montreal Cognitive Assessment [MoCA] score <22)
• major depression (Patient Health Questionnaire [PHQ-9] ≥20)
• severe pulmonary disease (i.e., oxygen-dependent)
• significant impairment from a prior stroke or other neurologic disease or injury
• high risk for non-adherence (i.e., unwilling or unable to comply with study requirements)
• current participation in physical therapy or another weight loss study
• current or recent use of weight loss medications (e.g., orlistat)
• prior weight loss procedure
• drug/substance abuse or excessive alcohol (> 14 drinks per week) within the past 6 months
• pregnant or pre-menopausal women
• peanut allergy
• milk allergy/lactose intolerance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehab Only	Exercise	Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
Rehab Only	Dietary Counseling	Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
Rehab+Weight Loss (WL)	Exercise	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
Rehab Only	Exercise Compliance	Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
Rehab+Weight Loss (WL)	Health Education	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
Rehab+Weight Loss (WL)	Exercise Compliance	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
Rehab+Weight Loss (WL)	Calorie-Restricted Diet	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
Rehab Only	Health Education	Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
Rehab+Weight Loss (WL)	Behavioral Modification	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
Rehab+Weight Loss (WL)	Weight-Loss Compliance	Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.

Primary Outcome Measures

Name	Time	Method
Compliance - Percentage of Sessions Attended	6 months	The percentage of exercise/counseling sessions attended (calculated as the number of sessions attended divided by the number of sessions prescribed multiplied by 100)
Feasibility - Number of Enrolled Participants	18 months	Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study
Retention - Percentage of Participants Who Returned for Follow-up Testing	6 months	The number of participants who returned for the 6-month follow-up visit divided by the total number of randomized participants multiplied by 100

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk (6MW) Test	Months 3 and 6	The 6MW test is a valid and reproducible measure of submaximal exercise capacity that reflects the level at which most activities of daily living are performed, predicts clinical events in cardiac patients, and is therefore a clinically meaningful outcome in cardiac rehabilitation studies. Participants were asked to walk at their own maximal pace on an established course, covering as much ground as they can during the allotted time, without running. Performance was measured by the total distance covered in meters.
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score	Months 3 and 6	Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The mental component summary (MCS) score is derived using a factor analysis technique that includes positive weights for the vitality, social functioning, role-emotional, and mental health scales and negative weights for the physical functioning, role-physical, bodily pain and general health scales.
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score	Months 3 and 6	Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The physical component summary (PCS) score is derived using a factor analysis technique that includes positive weights for the physical functioning, role-physical, bodily pain, general health and vitality scales and negative weights for the social functioning, role-emotional and mental health scales.
Body Weight	Months 3 and 6	Body weight measured in kg
Grip Strength	Months 3 and 6	Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Mobility - MAT-sf	Months 3 and 6	Mobility was assessed using the MAT-sf, a 10-item computer-based, self-administered assessment that uses animated video clips of 10 different tasks to illustrate various mobility-related challenges that cover a broad range of functioning. Participants provide an assessment of their ability to perform each task on the computer by clicking the appropriate response (yes/no, number of minutes, number of times). Scores range from 30 to 80, with higher scores indicative of better mobility.
Hemoglobin A1c	Months 3 and 6	Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Brachial Blood Pressure - Diastolic	Months 3 and 6	Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Expanded Short Physical Performance Battery (eSPPB)	Months 3 and 6	The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.
Arterial Stiffness	Months 3 and 6	Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV was measured in the supine position using the SphygmoCor XCEL system. PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time.
Brachial Blood Pressure - Systolic	Months 3 and 6	Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Aortic Blood Pressure - Systolic	Months 3 and 6	Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes.
Aortic Blood Pressure - Diastolic	Months 3 and 6	Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes.
Fasting Insulin	Months 3 and 6	Insulin was determined by a chemiluminescent immunoassay.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States