An interventional study of Exercise Intervention and Physical Activity Handout in Cardiac Amyloidosis, sponsored by Oregon Health and Science University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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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.
Habitual exercise has been shown to improve longevity and reduce overall mortality. Patients with ATTR-CM routinely experience reduced exercise tolerance and functional capacity as the disease progresses. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing quantitative exercise capacity and cardiorespiratory fitness in clinical testing, and peak oxygen consumption (peak VO2) serves as one of the most powerful prognostic markers in cardiovascular health. Lower peak VO2 values are strongly correlated with adverse cardiac events and mortality in individuals with ATTR-CM, including those on contemporary therapies. While major RCTs assessing TTR silencers and stabilizers have shown a reduction in the rate of decline of functional capacity compared to placebo, patients on active therapy still experience an overall decline in functional status. Existing clinical trials have not investigated the effects of a structured exercise training protocol on preventing this functional decline in patients with ATTR-CM. This study aims to evaluate whether an individualized exercise regimen provides additive improvements in exercise capacity and quality of life for patients with ATTR-CM who are receiving background TTR-directed therapy.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention arm will be prescribed a training plan and provided with a gym membership including personal training sessions. Participants will also be given a smartwatch to track activity.
Behavioral: Exercise Intervention
Participants randomized to the control arm will receive a Physical Activity Recommendations Handout and a smartwatch to track activity.
Behavioral: Physical Activity Handout
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.
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.
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
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
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
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
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
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
No study locations are listed for this record.
Plan to share: Yes — A limited access dataset generated from this project will rapidly be made available to the broader community for distribution to outside researchers according to established Oregon Health \& Science University policies. Exercise training plans developed as part of the study will be made available.
Supporting information: Study protocol
Start is estimated for Sep 2026; primary completion for Jul 2028, 22 months later.
Of 30 interventional studies with no phase under Amyloid Neuropathies, Familial, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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