NCT03922529: MACRO

Modified Application of Cardiac Rehabilitation for Older Adults

Completed NA Results posted Last updated 22 September 2025

What this trial tests

NA trial testing MACRO-I in Cardiovascular Diseases in 416 participants. Completed in 8 August 2024.

Timeline

4 November 2019

Primary endpoint
8 August 2024

8 August 2024

Quick facts

Lead sponsor	Daniel Forman, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	416
Start date	4 November 2019
Primary completion	8 August 2024
Estimated completion	8 August 2024
Sites	3 locations across United States

Drugs / interventions tested

• MACRO-I
• Usual Care

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
• Transition of Care — all drugs for Transition of Care →

Sponsor

Daniel Forman, MD

Who can join

70 and older, any sex, with Cardiovascular Diseases or Cardiac Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

AM-PAC-CAT - Basic Mobility Domain Primary · 3 months, i.e., Baseline to 3-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	5.1	± 7.5
Usual Care	5.0	± 5.4

AM-PAC-CAT - Basic Mobility Domain Secondary · Baseline to 6-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	4.9	± 6.7
Usual Care	5.2	± 5.9

AM-PAC-CAT - Basic Mobility Domain Secondary · Baseline to 12-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	4.9	± 7.3
Usual Care	5.3	± 6.5

AM-PAC-CAT - Daily Activity Domain Secondary · Baseline to 3-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	5.8	± 8.8
Usual Care	4.5	± 11.1

AM-PAC-CAT - Daily Activity Domain Secondary · Baseline to 6-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	6.3	± 10.0
Usual Care	5.2	± 10.6

AM-PAC-CAT - Daily Activity Domain Secondary · Baseline to 12-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Group	Value	95% CI
MACRO-I	6.9	± 11.2
Usual Care	5.1	± 11.3

Accelerometry Secondary · Baseline to 3-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Group	Value	95% CI
MACRO-I	37.3	± 95.8
Usual Care	13.9	± 115.4

Accelerometry Secondary · Baseline to 6-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Group	Value	95% CI
MACRO-I	34.0	± 100.8
Usual Care	18.3	± 127.4

Accelerometry Secondary · Baseline to 12-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Group	Value	95% CI
MACRO-I	44.8	± 121.6
Usual Care	12.9	± 119.1

PATIENT HEALTH QUESTIONNAIRE (PHQ-9) Secondary · Baseline to 3-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Group	Value	95% CI
MACRO-I	-2.1	± 3.1
Usual Care	-2.2	± 2.9

PATIENT HEALTH QUESTIONNAIRE (PHQ-9) Secondary · Baseline to 6-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Group	Value	95% CI
MACRO-I	-1.9	± 3.5
Usual Care	-2.2	± 2.8

PATIENT HEALTH QUESTIONNAIRE (PHQ-9) Secondary · Baseline to 12-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Group	Value	95% CI
MACRO-I	-1.7	± 3.0
Usual Care	-2.3	± 3.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for all randomized participants over a 1 year follow-up period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MACRO-I

Serious: 74/176 (42%)

Deaths: 8/176

Usual Care

Serious: 70/174 (40%)

Deaths: 12/174

Serious adverse events (86 terms)

Reaction	System	MACRO-I	Usual Care
HEART FAILURE	Cardiac disorders	—	—
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	Surgical and medical procedures	—	—
CHEST PAIN - CARDIAC	Cardiac disorders	—	—
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	—	—
MYOCARDIAL INFARCTION	Cardiac disorders	—	—
FALL	Injury, poisoning and procedural complications	—	—
DYSPNEA	Respiratory, thoracic and mediastinal disorders	—	—
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—
CARDIAC ARREST	Cardiac disorders	—	—
LUNG INFECTION	Infections and infestations	—	—
SYNCOPE	Nervous system disorders	—	—
ANEMIA	Blood and lymphatic system disorders	—	—
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
STROKE	Nervous system disorders	—	—
MITRAL VALVE DISEASE	Cardiac disorders	—	—
SINUS BRADYCARDIA	Cardiac disorders	—	—
VENTRICULAR TACHYCARDIA	Cardiac disorders	—	—
DEATH NOS	General disorders	—	—
EDEMA LIMBS	General disorders	—	—
FLU LIKE SYMPTOMS	General disorders	—	—
NON-CARDIAC CHEST PAIN	General disorders	—	—
SEPSIS	Infections and infestations	—	—
HYPOGLYCEMIA	Metabolism and nutrition disorders	—	—
ARTHRITIS	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (109 terms — click to expand)

Reaction	System	MACRO-I	Usual Care
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	—	—
FALL	Injury, poisoning and procedural complications	—	—
PAIN	General disorders	—	—
FLU LIKE SYMPTOMS	General disorders	—	—
UPPER RESPIRATORY INFECTION	Infections and infestations	—	—
DYSPNEA	Respiratory, thoracic and mediastinal disorders	—	—
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	Surgical and medical procedures	—	—
HYPERTENSION	Vascular disorders	—	—
CHEST PAIN - CARDIAC	Cardiac disorders	—	—
EDEMA LIMBS	General disorders	—	—
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—
CATARACT	Eye disorders	—	—
DIARRHEA	Gastrointestinal disorders	—	—
HYPOTENSION	Vascular disorders	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—
ARTHRITIS	Musculoskeletal and connective tissue disorders	—	—
ANEMIA	Blood and lymphatic system disorders	—	—
CARDIAC DISORDERS - OTHER, SPECIFY	Cardiac disorders	—	—
GASTROINTESTINAL PAIN	Gastrointestinal disorders	—	—
NAUSEA	Gastrointestinal disorders	—	—
NON-CARDIAC CHEST PAIN	General disorders	—	—
BRONCHIAL INFECTION	Infections and infestations	—	—
SINUSITIS	Infections and infestations	—	—
DIZZINESS	Nervous system disorders	—	—
SYNCOPE	Nervous system disorders	—	—
HYPOXIA	Respiratory, thoracic and mediastinal disorders	—	—
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	Skin and subcutaneous tissue disorders	—	—
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	Blood and lymphatic system disorders	—	—
SINUS BRADYCARDIA	Cardiac disorders	—	—
VERTIGO	Ear and labyrinth disorders	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—
FATIGUE	General disorders	—	—
LUNG INFECTION	Infections and infestations	—	—
SHINGLES	Infections and infestations	—	—
FRACTURE	Injury, poisoning and procedural complications	—	—
WOUND DEHISCENCE	Injury, poisoning and procedural complications	—	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—	—
HEADACHE	Nervous system disorders	—	—

Most-reported serious reactions: HEART FAILURE, SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY, CHEST PAIN - CARDIAC, INFECTIONS AND INFESTATIONS - OTHER, SPECIFY, MYOCARDIAL INFARCTION, FALL, DYSPNEA, RESPIRATORY FAILURE.

Data from ClinicalTrials.gov NCT03922529 adverse events section.

Sponsor's own description

Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical underuse of cardiac rehabilitation in older adults with a coaching model that addresses issues related to aging as a means to better facilitate cardiac rehabilitation (CR). MACRO is a randomized controlled trial (RCT) in which older adults with a CVD event are randomized between a MACRO intervention (MACRO-I) versus usual care. The MACRO-I is designed to facilitate CR as a means to augment functional recovery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Million Hearts Cardiac Rehabilitation Think Tank: Accelerating New Care Models.
   Beatty AL, Brown TM, Corbett M, Diersing D, et al · · 2021 · cited 51× · PMID 34587751 · DOI 10.1161/circoutcomes.121.008215
2. Medication review in hospitalised patients to reduce morbidity and mortality.
   Bülow C, Clausen SS, Lundh A, Christensen M. · · 2023 · cited 37× · PMID 36688482 · DOI 10.1002/14651858.cd008986.pub4
3. Never Too Old for Cardiac Rehabilitation.
   O'Neill D, Forman DE. · · 2019 · cited 31× · PMID 31543175 · DOI 10.1016/j.cger.2019.07.001
4. Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease.
   Schopfer DW, Whooley MA, Allsup K, Pabst M, et al · · 2020 · cited 30× · PMID 32954885 · DOI 10.1161/jaha.120.016456
5. Cardiac rehabilitation for older adults: current evidence and future potential.
   Alfaraidhy MA, Regan C, Forman DE. · · 2022 · cited 26× · PMID 35098848 · DOI 10.1080/14779072.2022.2035722
6. Modified Application of Cardiac Rehabilitation in Older Adults (MACRO) Trial: Protocol changes in a pragmatic multi-site randomized controlled trial in response to the COVID-19 pandemic.
   Forman DE, Racette SB, Toto PE, Peterson LR, et al · · 2022 · cited 11× · PMID 34823001 · DOI 10.1016/j.cct.2021.106633
7. Embedding and Sustaining a Focus on Function in Specialty Research and Care.
   Callahan KE, Boustani M, Ferrante L, Forman DE, et al · · 2021 · cited 5× · PMID 33064303 · DOI 10.1111/jgs.16860
8. Age Considerations in the Invasive Management of Acute Coronary Syndromes.
   Oberoi M, Ainani N, Abbott JD, Mamas MA, et al · · 2022 · PMID 39600832 · DOI 10.15420/usc.2021.29