Optimizing Aerobic Fitness in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Vermont Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>65 years old
ambulatory
enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
HIIT
Other interventionPatients 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 interventionPatients 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
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Usual Care GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Within 4 months of the intake assessment2
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).
Time frame
Within 4 months of the intake assessmentSecondary outcomes
1
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.
Time frame
Within 4 months of the intake assessment2
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
Time frame
Within 4 months of the intake assessment3
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.
Time frame
Within 4 months of the intake assessment4
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.
Time frame
Within 4 months of the intake assessmentOther outcomes
1
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).
Time frame
From completion of intervention (4 months) to follow-up (26 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov