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Registry update — unassessed

A Prospective, Randomized, Multicenter Clinical Trial on the Effect of a Home-Based Multicomponent Exercise Program Combined With Nutritional Supplementation in Patients With Transthyretin Cardiac Amyloidosis

Trial registry update: COMPLETED. No results reported in the supplied registry record.

RCTN=47Minor significance
Reporter brief

What this changes

The finding has not established an approved change to our evidence assessment.

Source date: Sep 25, 2026 · Discovered: Sep 25, 2026 · Assessed: — · Research update

What it does not prove

  • The abstract provides no results or findings—no effect sizes, P-values, or outcome data are reported, making it impossible to determine whether the intervention had any effect
  • With 47 participants split across three groups, statistical power was likely limited, especially for detecting effects in secondary outcomes like body composition or frailty
  • Study design alone cannot establish whether observed changes would persist beyond 12 weeks or translate to clinical benefit in this population

Extracted from supplied source material; model confidence is not a measured probability of correctness.

Design
Rct
Sample size
47
Duration
3 months
Population
Adults aged 70 years or older with confirmed transthyretin cardiac amyloidosis (TTR-CA)
Primary outcome
Change in 6-minute walk test distance and handgrip strength from baseline to 12 weeks
Effect size
—
Significance
Not reported
Journal
Universidad de Burgos
Published
Sep 25, 2026

Recorded source passages

Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.

EFICAC-TTR is a prospective, randomized, multicenter study designed to evaluate the effects of a 12-week home-based multicomponent exercise program combined with nutritional supplementation in adults aged 70 years or older with confirmed TTR-CA.
A total of 47 participants were randomized to one of three parallel groups: (1) usual medical care; (2) a home-based multicomponent exercise program plus microcrystalline cellulose control supplementation; or (3) the same exercise program plus creatine monohydrate (3 g/day) and beta-hydroxy-beta-methylbutyrate (HMB, 3 g/day).
The primary functional outcomes are change in 6-minute walk test distance and handgrip strength from baseline to 12 weeks. Secondary outcomes include body composition, frailty, quality of life, and nutritional and clinical variables.

Assessment history

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