Optimizing Aerobic Fitness in Older Adults

NCT06951620 | Recruiting DMC

• 2 other identifiers: #STUDY00002693R01AG084636
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Aerobic Capacity; High Intensity Interval Training

Keywords

cardiac rehabilitation; HIIT; MICT; exercise in older adults; aerobic capacity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes in Quality of Life- Cardiac Specific

  Within 4 months of the intake assessment

• Changes in Depressive Symptoms

  Within 4 months of the intake assessment

• Changes in Executive Function (digit span)

  Within 4 months of the intake assessment

• Changes in Executive Function (BRIEF)

  Within 4 months of the intake assessment

• Changes in Executive Function (trail making)

  Within 4 months of the intake assessment

Other Outcomes (1)

• Maintenance of Fitness Following Intervention

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

Study Arms (2)

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

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

Other: MICT

Interventions

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)

Intervention Group

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

Usual Care Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UVMMC Cardiac Rehabilitation

South Burlington, Vermont, 05403, United States

RECRUITING

Study Officials

• Sherrie Khadanga MD, Principal Investigator, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Savage, Research Coordinator

CONTACT

802-847-4545; patrick.savage@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 30, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

US (1)