Elsevier

Progress in Cardiovascular Diseases

Volume 57, Issue 2, September–October 2014, Pages 144-151
Progress in Cardiovascular Diseases

Therapeutic Interventions for Frail Elderly Patients: Part II. Ongoing and Unpublished Randomized Trials

https://doi.org/10.1016/j.pcad.2014.07.005Get rights and content

Abstract

There is increasing momentum to measure frailty in clinical practice given its proven value as a predictor of outcomes, particularly in elderly patients with cardiovascular disease. The number of randomized clinical trials targeting frail older adults has been modest to date. Therefore, we systematically searched the ClinicalTrials.gov registry in order to review the frailty intervention trials that had been actively initiated or completed but not yet published. The interventions studied were exercise training in 2 trials, nutritional supplementation in 3 trials, combined exercise plus nutritional supplementation in 5 trials, pharmaceutical agents in 5 trials, multi-dimensional programs in 2 trials, and home-based services in 3 trials. Their respective study designs, populations, interventions, and planned outcomes are presented in this article.

Section snippets

Methods

The ClinicalTrials.gov registry was queried using the following search string: (frail OR frailty OR sarcopenic OR sarcopenia) AND (randomized). The “Interventional” filter was selected. The inclusion criteria for this review were: (1) randomized controlled trial, (2) ongoing or completed but not yet published, (3) population of older adults with frailty/pre-frailty or sarcopenia as determined by an objective assessment tool (broadly defined as a multi-item frailty scale such as Fried’s,5 low

Results

The search identified 265 entries, of which 20 met the inclusion criteria for this review (Table 1, Fig 2). The official status was not yet recruiting in 5 RCTs, recruiting in 6, active but not recruiting in 4, and completed but not yet published in 5. The frailty criteria used to determine eligibility were PPTs in 8 RCTs, Fried’s scale in 6, muscle mass with or without PPTs in 3, and other scales in 3. Five RCTs focused on individuals with a specific comorbidity: stable coronary artery

Discussion

One half of registered RCTs are evaluating exercise and/or nutrition, which have long been recognized as therapeutic cornerstones for frailty. These RCTs are all short-term in design, ranging from 3 to 6 months, and it remains to be seen whether this is sufficient time to reverse existing frailty and yield clinically detectable benefits. Regular exercise and physical activity have been shown to prevent or delay incident frailty.7 Two systematic reviews including frail and non-frail older adults

Statement of Conflict of Interest

All authors declare that there are no conflicts of interest.

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Statement of Conflict of Interest: see page 150.

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