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NCT Number: NCT06951620

Optimizing Aerobic Fitness 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.

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Key information

Conditions

Aerobic Capacity High Intensity Interval Training

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVMMC Cardiac Rehabilitation

South Burlington, Vermont, 05403, United States

Location status: Recruiting

Location contact

Sheena Barnes Clinic Supervisor

CONTACT

[email protected]

802-847-4600

Sherrie Khadanga PI, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIIT

Other

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)

MICT

Other

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

Primary outcomes

  1. Change in Aerobic fitness

    Time frame: Within 4 months of the intake assessment

    Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).

  2. Change in 30 sec sit-to-stand test (STS)

    Time frame: Within 4 months of the intake assessment

    Changes in STS will be measured from intake to completion of the intervention (4 months after intake).

Secondary outcomes

  1. Changes in Quality of Life- Cardiac Specific

    Time frame: Within 4 months of the intake assessment

    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.

  2. Changes in Depressive Symptoms

    Time frame: Within 4 months of the intake assessment

    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

  3. Changes in Executive Function (digit span)

    Time frame: Within 4 months of the intake assessment

    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.

  4. Changes in Executive Function (BRIEF)

    Time frame: Within 4 months of the intake assessment

    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.

  5. Changes in Executive Function (trail making)

    Time frame: Within 4 months of the intake assessment

    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.

  6. Changes in Physical Function (Six Minute Walk Test)

    Time frame: Within 4 months of the intake assessment

    Changes in 6MWT will be measured from intake to completion of the intervention. Distance walked in meters (m) will be recorded.

  7. Changes in Enjoyment of Exercise (PACES)

    Time frame: Within 4 months of the intake assessment

    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

  8. Changes in Anxiety

    Time frame: Within 4 months of the intake assessment

    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

Other outcomes

  1. Maintenance of Fitness Following Intervention

    Time frame: From completion of intervention (4 months) to follow-up (26 weeks).

    Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Savage, Research Coordinator

CONTACT

[email protected]

802-847-4545

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 30, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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