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Individualized Exercise Training in Cardiac Amyloidosis

ConditionCardiac Amyloidosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

Numerous clinical trials have demonstrated that transthyretin (TTR)-directed medical therapies can reduce the rate of functional decline in patients with transthyretin cardiac amyloidosis (ATTR-CM). However, patients treated with these therapies often experience a progressive reduction in exercise capacity despite treatment. Further, no randomized controlled trials (RCTs) have assessed the effects of exercise intervention in patients with ATTR-CM receiving TTR-directed therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of ATTR-cardiac amyloidosis

Able to perform endurance and resistance exercise

Currently on stable dose of TTR-directed therapy, if on therapy

Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.

Disqualifiers

Sustained ventricular arrhythmias or ICD shock within 6 months

Severe valvular stenosis

Pregnancy

Recent acute coronary syndrome or coronary artery bypass < 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention

    Behavioral

    A 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch to exercise.

  • Physical Activity Handout

    Behavioral

    An American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over a 3-month period.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Oxygen Consumption (Peak VO2)

CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.

Time frame
12 weeks
2

Ventilatory Efficiency (VE/VCO2 Slope)

Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.

Time frame
12 weeks

Secondary outcomes

1

Short Form - 36 (SF-36)

The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and health status.

Time frame
12 weeks
2

Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)

Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.

Time frame
12 weeks
3

Groningen Frailty Indicator (GFI)

The GFI is a 15-item self-report questionnaire used to determine overall frailty level across physical, cognitive, social, and psychological domains. Scores range from 0 to 15, with higher scores representing greater degrees of frailty.

Time frame
12 weeks
4

Short Physical Performance Battery (SPPB)

The Short Physical Performance Battery (SPPB) is a standardized performance-based assessment of lower-extremity physical function in older adults. It consists of three components: standing balance, usual gait speed, and repeated chair-stand performance. Each component is scored from 0 to 4 points, for a total score ranging from 0 to 12, with higher scores indicating better physical function.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: