Aerobic CapacityNCT06951620
Optimizing Aerobic Fitness in Older Adults
A study testing HIIT and MICT in people with Aerobic Capacity and High Intensity Interval Training, run by University of Vermont Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aerobic Capacity, High Intensity Interval Training
- What is being tested?
- HIIT and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- ambulatory
- enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UVMMC Cardiac Rehabilitation
South Burlington, Vermont, 05403
Sheena Barnes Clinic Supervisor, 802-847-4600, sheena.barnes@uvmhealth.org
Sherrie Khadanga PI, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Aerobic Capacity, High Intensity Interval Training
- Being tested
- HIIT, MICT
- Keywords
- cardiac rehabilitation, HIIT, MICT, exercise in older adults, aerobic capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
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)
MICTOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Other: HIIT |
| Usual Care Group | Experimental | 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 Receives: Other: MICT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Within 4 months of the intake assessment
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: Within 4 months of the intake assessment
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Within 4 months of the intake assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start17 Apr 2025
- Primary completion15 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sherrie Khadanga, University of Vermont Medical Center
- Investigators
- Sherrie Khadanga MD, Principal Investigator, MD, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951620
- Sponsor's protocol ID
- #STUDY00002693
- Other IDs
- R01AG084636
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT06951620
- Acronym / sponsor ID
- #STUDY00002693
- Conditions
- Aerobic Capacity, High Intensity Interval Training
- Keywords
- cardiac rehabilitation, HIIT, MICT, exercise in older adults, aerobic capacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: HIITPatients 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 |
| Usual Care Group | Experimental | Other: MICTPatients 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >65 years old
- ambulatory
- enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITPatients 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) | Other | Intervention Group |
| MICTPatients 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 | Usual Care Group |
Primary outcome
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).
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).
8 secondary outcomes
Changes in Quality of Life- Cardiac Specific
Time frame: Within 4 months of the intake assessment
Changes in Depressive Symptoms
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (digit span)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (BRIEF)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (trail making)
Time frame: Within 4 months of the intake assessment
Changes in Physical Function (Six Minute Walk Test)
Time frame: Within 4 months of the intake assessment
Changes in Enjoyment of Exercise (PACES)
Time frame: Within 4 months of the intake assessment
Changes in Anxiety
Time frame: Within 4 months of the intake assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherrie Khadanga MD, Principal Investigator, MD principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and MICT in people with Aerobic Capacity and High Intensity Interval Training, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Savage, Research Coordinator (802-847-4545, patrick.savage@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aerobic fitness (time frame: Within 4 months of the intake assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.