Optimizing Aerobic Fitness in Older Adults

Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults

Hospitalization and treatment for cardiovascular disease is one of the main contributors to disability in older adults. Moderate intensity continuous aerobic and resistance training have been the cornerstone of cardiac rehabilitation (CR) for decades to remediate hospital-acquired functional deficits, but some groups receive less or minimal functional benefit from this training. The proposed studies seek to optimize recovery of aerobic fitness and physical function among older cardiac patients using a novel high intensity training regimen with the long-term goal of reducing subsequent disability and improving clinical outcomes.

Study Overview

• Status: Recruiting
• Conditions: High Intensity Interval Training; Aerobic Capacity
• Intervention / Treatment: Other: HIIT; Other: MICT

Detailed Description

Clinical events and hospitalization often initiate disability in older adults with cardiovascular disease (CVD) being the primary cause of hospital acquired disability. Cardiac rehabilitation (CR) was designed to correct this disability, with moderate intensity, continuous aerobic training (MICT) as its foundation but some patients, including older adults, receive less functional benefit from MICT. Attention has recently focused on high intensity interval aerobic training (HIIT) as an alternative to MICT because it improves aerobic fitness to a greater extent and is safe and feasible for older adults enrolled in CR; however, neither HIIT nor MICT address age-related atrophy and weakness. Resistance training is a core component of CR meant to correct these deficits, but the moderate intensity resistance training (MIRT) most commonly used has minimal effects on these outcomes. Thus, there is an unmet clinical need for multi-modal exercise interventions that address the unique needs of older adult patients enrolled in CR to optimize improvements in functional recovery and clinical outcomes.

The investigators will conduct the first direct comparison of HIIT+HIRT to MICT+MIRT to improve VO2peak and physical function in older men and women enrolled in CR.

Aim 1: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase VO2peak in older adult patients enrolled in CR Aim 2: Determine the efficacy of combined HIIT+HIRT vs MICT+MIRT to increase physical function in older adult patients enrolled in CR.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Savage, Research Coordinator; Phone Number: 802-847-4545; Email: patrick.savage@uvmhealth.org

Study Locations

• United States
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Recruiting
      • UVMMC Cardiac Rehabilitation
      • Contact: Sheena Barnes Clinic Supervisor; Phone Number: 802-847-4600; Email: sheena.barnes@uvmhealth.org
      • Principal Investigator: Sherrie Khadanga PI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >65 years old
• ambulatory
• enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited

Exclusion Criteria:

• have an active malignancy (excluding non-melanoma skin cancer or low grade prostate cancer under surveillance)
• unwilling to comply with the exercise prescription they may be assigned to
• have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio <1.0

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to High intensity training	Other: HIIT; Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to High intensity training (HIIT)
Experimental: Usual Care Group; Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to Moderate intensity training	Other: MICT; Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to Moderate intensity training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aerobic fitness	Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Change in 30 sec sit-to-stand test (STS)	Changes in STS will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Executive Function (BRIEF)	Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.	Within 4 months of the intake assessment
Changes in Quality of Life- Cardiac Specific	Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.	Within 4 months of the intake assessment
Changes in Depressive Symptoms	Changes in reported depressive symptoms. The Patient Health Questionnaire (PHQ-9) will be measured from intake to completion of the intervention (4 months after intake). Scores range from 0-27 with higher scores associated with severity of depression	Within 4 months of the intake assessment
Changes in Executive Function (digit span)	Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.	Within 4 months of the intake assessment
Changes in Executive Function (trail making)	Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.	Within 4 months of the intake assessment
Changes in Physical Function (Six Minute Walk Test)	Changes in 6MWT will be measured from intake to completion of the intervention. Distance walked in meters (m) will be recorded.	Within 4 months of the intake assessment
Changes in Enjoyment of Exercise (PACES)	Changes in Enjoyment of Exercise will be assessed with the validated Physical Activity Enjoyment Scale and will be measured from intake to completion of the intervention. THe score ranges from 0-48 and score below 24 is interpreted as lower enjoyment of physical activity	Within 4 months of the intake assessment
Changes in Anxiety	Changes in reported anxiety symptoms. The Generalized Anxiety Disorder questionnaire will be measured from intake to completion of the intervention. Rated from 0-7, the higher the score the more anxious	Within 4 months of the intake assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Fitness Following Intervention	Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (26 weeks).

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sherrie Khadanga MD, Principal Investigator, MD, University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: aerobic capacity; HIIT; cardiac rehabilitation; MICT; exercise in older adults
• Other Study ID Numbers: #STUDY00002693; R01AG084636 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No