CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study
ConditionCardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18
New York Heart Association (NYHA) Class I-III Heart Failure
Able to Exercise
On stable treatment for their cardiac amyloidosis or under active surveillance
Disqualifiers
Inability to provide informed consent
Inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks
NYHA Class IV Heart Failure
Pulmonary disease requiring home oxygen
Trial design
Design model
Parallel
Treatments tested in this trial
• Cardiac Rehabilitation
BehavioralIntervention group will have baseline 6-minute walk test and cardiopulmonary exercise test (CPET) testing followed by supervised cardiac rehabilitation program including planned 3 one hour sessions a week for a total of 12 weeks (planned 36 sessions). A post intervention 6-minute walk test and CPET test will be performed within 2 weeks of completion of the 12 week program.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: cardiac rehabilitation groupExperimental treatment 1 intervention
Group B: control group - no interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants that complete at least 75% of prescribed cardiac rehab sessions
Feasibility of cardiac rehab as measured by number of participants that complete at least 75% of prescribed cardiac rehab sessions.
Time frame
Week 12Secondary outcomes
1
Change in cardiorespiratory fitness - maximal VO2 rates
Change in cardiorespiratory fitness as assessed by maximal (max) rate (V) of oxygen (O₂) your body is able to use during exercise VO2 (ml/kg/min ) on cardiopulmonary exercise test (CPET). Vo2 Max scores can vary based on a number of factors in addition to fitness, such as your gender, age and genetics, but a vo2 max measurement for an average person in their mid 30s to mid 40s is likely to be around: Women - 31 ml oxygen/kg of body weight/minute. Men - 42 ml oxygen/kg of body weight/minute.
Time frame
Week 122
Change in cardiorespiratory fitness - Ventilatory Efficiency (VE/VCO2) rates
Ventilatory equivalent for carbon dioxide ( ˙VE/ ˙VCO2) identifies the second ventilatory threshold, namely, the point in time when ventilatory drive starts increasing relative to ˙VCO2 (i.e., when hyperventilation occurs).
Time frame
Week 123
Change in cardiorespiratory fitness - quality of life (KCCQ) Cardiomyopathy Questionnaire (Kansas City) scores
KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame
Week 124
Change in cardiorespiratory fitness - chronotropic incompetence scores
the inability of the heart to increase its rate commensurate with increased activity or demand, is common in patients with cardiovascular disease, produces exercise intolerance which impairs quality-of-life - chronotropic incompetence is usually defined as failure to achieve a chronotropic index of 0.8 or higher (i.e., falling below 97.5 percent of healthy adults).
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov