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      Effects of a 12-week intrinsic foot muscle strengthening training (STIFF) on gait in older adults: a parallel randomized controlled trial protocol

      , , ,
      BMC Sports Science, Medicine and Rehabilitation
      Springer Science and Business Media LLC

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          Abstract

          Background

          Falling is highly prevalent among older adults and has serious impact. Age-induced mobility impairments, such as gait modifications, are strongly associated with increased fall risk. Among fall prevention interventions, those including exercises are most effective. However, there is an urgent need to further improve these kinds of interventions. Strengthening the plantar intrinsic foot muscles might benefit mobility in older adults, which may contribute to the reduction of fall risk. The aim of this paper is to provide a protocol to investigate the effect of a plantar intrinsic foot muscle strengthening training versus no training on gait and intrinsic foot muscle function in older adults who are involved in a functional exercise program.

          Methods

          For this assessor-blinded RCT, older adults (> 65 years) are recruited who are involved in a group-based functional exercise program. Eligibility criteria include: being able to ambulate 10 m barefoot without using a walking aid and reporting to have either fear of falling or experienced a fall in the previous 12 months or have difficulties with mobility, gait, or balance in daily life. Participants are randomly assigned to an intervention and a control group. The intervention group follows a 12-week plantar intrinsic foot muscle strengthening training. The training consists of isolated and functional foot exercises to be performed 5 times a week, each session lasting approximately 20 min. The training is supervised once a week and the intensity gradually increases based on the participant’s progression. Both groups keep a diary to report physical activities, fall incidents and movement related discomfort. The control condition is limited to keeping this diary. Data are collected at baseline and post-intervention. The trial outcomes are the between group differences in the mean change from baseline in maximum gait speed (primary outcome measure), capacity and strength of the plantar intrinsic foot muscles, foot and ankle biomechanics during gait, and various other fall risk-related variables. ANCOVA’s are used to analyze the trial outcomes.

          Discussion

          The results of this RCT will offer recommendations, related to plantar intrinsic foot muscle strengthening, to existing fall preventive exercise programs.

          Trial registration

          The trial is registered in the United States National Library of Medicine through ClinicalTrials.gov (NCT05531136, 07/26/2022).

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          Most cited references73

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          The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment.

          To develop a 10-minute cognitive screening tool (Montreal Cognitive Assessment, MoCA) to assist first-line physicians in detection of mild cognitive impairment (MCI), a clinical state that often progresses to dementia. Validation study. A community clinic and an academic center. Ninety-four patients meeting MCI clinical criteria supported by psychometric measures, 93 patients with mild Alzheimer's disease (AD) (Mini-Mental State Examination (MMSE) score > or =17), and 90 healthy elderly controls (NC). The MoCA and MMSE were administered to all participants, and sensitivity and specificity of both measures were assessed for detection of MCI and mild AD. Using a cutoff score 26, the MMSE had a sensitivity of 18% to detect MCI, whereas the MoCA detected 90% of MCI subjects. In the mild AD group, the MMSE had a sensitivity of 78%, whereas the MoCA detected 100%. Specificity was excellent for both MMSE and MoCA (100% and 87%, respectively). MCI as an entity is evolving and somewhat controversial. The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting MCI as currently conceptualized in patients performing in the normal range on the MMSE.
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            The behaviour change wheel: A new method for characterising and designing behaviour change interventions

            Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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              SPIRIT 2013 statement: defining standard protocol items for clinical trials.

              The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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                Author and article information

                Journal
                BMC Sports Science, Medicine and Rehabilitation
                BMC Sports Sci Med Rehabil
                Springer Science and Business Media LLC
                2052-1847
                December 2024
                July 20 2024
                : 16
                : 1
                Article
                10.1186/s13102-024-00944-z
                d0f01922-fdaa-479b-b42b-9f94a96152e1
                © 2024

                https://creativecommons.org/licenses/by/4.0

                https://creativecommons.org/licenses/by/4.0

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