Evidence map›Paper›PMID 41818185›Full record

ArticlePloS one2026

Study protocol for a multiarm, randomized controlled trial to determine the effectiveness of community-based frailty rehabilitation to improve physical function in older adults: The OPTIMAL Fitness Trial.

Alexandra Papaioannou, Courtney Kennedy, Justin Lee, Patricia Hewston, Caitlin McArthur, Shyam Maharaj, Jonathan Adachi, Pauline Boulos, Raja Bobba, Alexander Rabinovich and 17 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03824106 (Frailty Rehabilitation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03824106 narecruitingnot on this map

Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging

TypeinterventionalSponsorMcMaster UniversityRan2022 to 2025Enrolled324ConditionsFrailtyArmsControl, Group Exercise, Nutrition and Medication review, Protein Supplement, Vitamin D
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Alexandra PapaioannouDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0001-9412-0932
Courtney KennedyDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Justin LeeDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Patricia HewstonDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Caitlin McArthurGeras Centre for Aging Research, Hamilton Health Sciences, St. Peter's Hospital, Hamilton, Ontario, Canada.
Shyam MaharajHamilton Health Sciences, Hamilton, Ontario, Canada.
Jonathan AdachiDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Pauline BoulosDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Raja BobbaDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Alexander RabinovichDepartment of Surgery, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0009-0008-4890-4603
Brian McKennaEscarpment Health Centre, Hamilton, Ontario, Canada.ORCID https://orcid.org/0009-0007-7972-4181
Lisa PalubiskiEscarpment Health Centre, Hamilton, Ontario, Canada.
Dee ManginDepartment of Family Medicine, University of Otago, Christchurch, New Zealand.
Lehana ThabaneDepartment of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, Ontario, Canada.
Sharon MarrDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Sharon KaasalainenSchool of Nursing, McMaster University, Hamilton, Ontario, Canada.
Jean-Éric TarrideDepartment of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, Ontario, Canada.
Olga TheouSchool of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada.
David ArmstrongDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Ahmed NegmGeras Centre for Aging Research, Hamilton Health Sciences, St. Peter's Hospital, Hamilton, Ontario, Canada.
Michael NoseworthySchool of Biomedical Engineering, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-1464-159X
Kenneth RockwoodDepartment of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Lisa DolovichDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0002-0061-6783
Hajar Abu AlrobDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Genevieve HladyshSchool of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
Karen ThompsonDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
George IoannidisDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFrailty in older adults is on the rise with the rapid aging population. Frailty is dynamic and proven to be reversible or treatable. Evidence regarding the clinical effectiveness of community-based frailty interventions is limited. Frailty rehabilitation has the potential to be an accessible community-based intervention that may enable independence. We will examine a model of frailty rehabilitation and consider key components for improving physical function, frailty, sarcopenia, and cost-effectiveness.

methodsA multiarm, parallel-group, partially blinded, randomized controlled trial will compare the clinical and cost-effectiveness of OPTimizing Independence, Mobility, and Active Life (OPTIMAL) Fitness multimodal (group exercise, nutritional coaching/supplementation, medication optimization) versus OPTIMAL Fitness exercise-only and control. Participants in the OPTIMAL Fitness multimodal and exercise-only groups will attend exercise classes twice weekly for 4 months and be provided with a tailored one-hour home exercise program. We will recruit community-dwelling older adults living with frailty aged ≥65 years. Eligibility includes a FRAIL scale score of ≥2 (prefrail or frail), ability to ambulate 25 meters, follow two-step commands, and not attend another group exercise program. The target sample size is 324 participants (n = 108 per arm). The primary outcome is physical function measured via the Short Performance Physical Battery and the 400m Walk Test. Secondary outcomes include frailty change, sarcopenia, cognition, affect, quality of life, and healthcare utilization. Outcome analysis will be performed via generalized linear model analysis. Analyses will be based on the intention-to-treat principle. This protocol is guided by the Standard Protocol Items: Recommendations for Interventional Trials statement. DISCUSSION: This trial is the first to determine whether a community-based frailty rehabilitation intervention can improve physical function in older adults with frailty and the level of intervention needed. The results from the OPTIMAL Fitness study will guide the development of a standardized program that could be implemented in global regions.

trial registrationClinicalTrials.gov Identifier: NCT03824106 Registered January 31, 2019, https://www.clinicaltrials.gov/study/NCT03824106.

Indexed as

Exercise TherapyFrail ElderlyFrailtyPhysical FitnessAgedAged, 80 and overCost-Benefit AnalysisFemaleHumansIndependent LivingMaleRandomized Controlled Trials as Topic

Identifiers

PMID41818185
PMCPMC12981438

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.