Home workouts and shakes aim to boost strength in heart disease patients
NCT ID NCT07343999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a home-based exercise program combined with nutritional supplements can improve walking ability and muscle strength in people aged 70 and older with transthyretin cardiac amyloidosis, a heart condition that causes weakness and frailty. About 102 participants will be randomly assigned to usual care, exercise with fiber supplements, or exercise with protein-like supplements. The main goal is to see if these approaches safely improve physical function and quality of life over 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥70 years. * Confirmed diagnosis of transthyretin cardiac amyloidosis (TTR-CA) based on positive bone scintigraphy with diphosphonates (Perugini grade 2 or 3) and absence of monoclonal protein. * Clinical stability during the 4 weeks prior to enrollment. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Light-chain (AL) amyloidosis or other non-TTR amyloidosis variants. * Absolute medical contraindication to moderate-intensity exercise. * Severe comorbid conditions with an estimated life expectancy \<6 months. * Severe cognitive impairment (Mini-Mental State Examination score \<20). * Concurrent participation in another clinical trial or structured exercise program. * Known allergy or intolerance to creatine, beta-hydroxy-beta-methylbutyrate (HMB), or microcrystalline cellulose. * Severe renal impairment requiring dialysis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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