Clinical trial NCT06951620: Optimizing Aerobic Fitness in Older Adults
Official title: Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aerobic Capacity
High Intensity Interval Training
Keywords: cardiac rehabilitation
HIIT
MICT
exercise in older adults
aerobic capacity
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-30
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Aerobic fitness
timeFrame: Within 4 months of the intake assessment
measure: Change in 30 sec sit-to-stand test (STS)
timeFrame: Within 4 months of the intake assessment
Secondary outcomes:
measure: Changes in Quality of Life- Cardiac Specific
timeFrame: Within 4 months of the intake assessment
measure: Changes in Depressive Symptoms
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (digit span)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (BRIEF)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (trail making)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Physical Function (Six Minute Walk Test)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Enjoyment of Exercise (PACES)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Anxiety
timeFrame: Within 4 months of the intake assessment
Other outcomes:
measure: Maintenance of Fitness Following Intervention
timeFrame: From completion of intervention (4 months) to follow-up (26 weeks).
Locations:
city: South Burlington
country: United States
facility: UVMMC Cardiac Rehabilitation
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: Sherrie Khadanga MD, Principal Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References: