Active elderly and health—can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial

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Abstract

Background

Aging is marked by a progressive rise in chronic diseases with an impact on social and healthcare costs. Physical activity (PA) may soothe the inconveniences related to chronic diseases, has positive effects on the quality of life and biological rhythms, and can prevent the decline in motor functions and the consequent falls, which are associated with early death and disability in older adults.

Methods

We randomized 120 over-65 males and females into groups of similar size and timing and will give each either moderate physical activity or cultural and recreational activities. Being younger than 65 years, inability to participate in physical activity for any medical reason, and involvement in a massive program of physical exercise are the exclusion criteria. The primary outcome measures are: quality of life, walking speed, and postural sway. Participants are tested at baseline, post-treatment, and 6-month (24 weeks) and 12-month (48 weeks) follow-ups.

Discussion

This study aims at improving the quality of life, wellness, and cognitive functioning in the elderly through a low-cost affordable program of moderate physical activity. Given the growing aging of the world population and the social and economic burden of disability in the elderly, our results might have a major impact on future practices.

Trial registration

ClinicalTrials.gov NCT03858114. Registered on 28 February 2019.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05278-6.

Related collections

Most cited references 25

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K Kroenke, R L Spitzer, J. Williams (2001)

While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.

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SPIRIT 2013 statement: defining standard protocol items for clinical trials.

An-Wen Chan, Jennifer M Tetzlaff, Douglas G. Altman … (2013)

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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A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

J. Ware, M Kosinski, S Keller (1996)

Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.

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Author and article information

Contributors

Mauro Giovanni Carta: mgcarta@tiscali.it

Giulia Cossu: giuliaci@icloud.com

Elisa Pintus: pintuselisa@yahoo.it

Rosanna Zoccheddu: rosannazaccheddu@gmail.com

Omar Callia: calliaom@gmail.com

Giuliana Conti: giulianaconti5@gmail.com

Mirra Pintus: mirra.pintus@hotmail.it

Cesar Ivan Aviles Gonzalez: infermiere2010@gmail.com

Maria Valeria Massidda: mmassidda@aoucagliari.it

Gioia Mura: gmura@unica.it

Claudia Sardu: csardu@unica.it

Paolo Contu: contumail@gmail.com

Luigi Minerba: lminerba@gmail.com

Roberto Demontis: demrob@unica.it

Massimiliano Pau: massimiliano.pau@dimcm.unica.it

Gabriele Finco: gabriele.finco@gmail.com

Eleonora Cocco: ecocco@unica.it

Maria Petronilla Penna: penna@unica.it

Germano Orrù: orru@unica.it

Goce Kalcev: gocekalcev@yahoo.com

Federico Cabras: federicocabras@yahoo.it

Stefano Lorrai: stefanolorrai@live.it

Andrea Loviselli: alovise2@gmail.com

Fernanda Velluzzi: fernandavelluzzi@gmail.com

Marco Monticone: marco.monticone@unica.it

Enrico Cacace: cacace@medicina.unica.it

Mario Musu: mmusu@unica.it

Franco Rongioletti: rongioletti@unica.it

Alberto Cauli: cauli@unica.it

Valeria Ruggiero: ruggiero@unica.it

Alessandra Scano: alessandrascano@libero.it

Antonio Crisafulli: crisaful@unica.it

Sofia Cosentino: scosenti@unica.it

Laura Atzori: atzoril@unica.it

Elena Massa: elena.massa@unica.it

Quirico Mela: mela@unica.it

Dario Fortin: dario.fortin@unitn.it

Gianmario Migliaccio: ciao@migliaccio.it

Antonio Egidio Nardi: antonioenardi@gmail.com

Matthias Angermeyer: angermeyer@aon.at

Antonio Preti:

ORCID: http://orcid.org/0000-0001-9003-9838

apreti@tin.it

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 7 May 2021

Publication date PMC-release: 7 May 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 331

Affiliations

[1 ]GRID grid.7763.5, ISNI 0000 0004 1755 3242, Department of Medical Sciences and Public Health, , University of Cagliari, ; Cagliari, Italy

[2 ]GRID grid.460105.6, Azienda Ospedaliero Universitaria di Cagliari, ; Cagliari, Italy

[3 ]GRID grid.7763.5, ISNI 0000 0004 1755 3242, Dipartimento di Ingegneria meccanica, chimica e dei materiali, , Università degli Studi di Cagliari, ; Cagliari, Italy

[4 ]GRID grid.7763.5, ISNI 0000 0004 1755 3242, Dipartimento di Pedagogia, psicologia, filosofia, , Università degli Studi di Cagliari, ; Cagliari, Italy

[5 ]GRID grid.7763.5, ISNI 0000 0004 1755 3242, International PhD in Innovation Sciences and Technologies, , University of Cagliari, ; Cagliari, Italy

[6 ]Vita-Salute - S. Raffaele University, Milan, Italy

[7 ]GRID grid.11696.39, ISNI 0000 0004 1937 0351, Department of Psychology and Cognitive Sciences, , University of Trento, ; Rovereto, Italy

[8 ]Comitato Olimpico Nazionale Italiano – CONI Sardegna, Cagliari, Italy

[9 ]GRID grid.8536.8, ISNI 0000 0001 2294 473X, Federal University of Rio de Janeiro, ; Rio de Janeiro, Brazil

[10 ]GRID grid.22937.3d, ISNI 0000 0000 9259 8492, Center for Public Mental Health, ; Gosim, Austria

[11 ]GRID grid.7605.4, ISNI 0000 0001 2336 6580, Department of Neuroscience, University of Turin, ; Turin, Italy

Author information

Antonio Preti http://orcid.org/0000-0001-9003-9838

Article

Publisher ID: 5278

DOI: 10.1186/s13063-021-05278-6

PMC ID: 8103665

PubMed ID: 33962664

SO-VID: 42d58787-b98e-48ec-8ea4-72cc40a85c72

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 23 May 2020

Date accepted : 16 April 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100007359, Fondazione Banco di Sardegna;

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: aging,physical activity,quality of life,rct,cognition,depression

Data availability:

ScienceOpen disciplines: Medicine

Keywords: aging, physical activity, quality of life, rct, cognition, depression

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Active elderly and health—can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

Related collections

Neuronal Signaling

Most cited references 25

The PHQ-9: validity of a brief depression severity measure.

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

Author and article information

Contributors

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Affiliations

Author information

Article

History

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Comments

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Cited by 17

Most referenced authors 525