Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults

Kristin Taraldsen, A. Stefanie Mikolaizak, Andrea B. Maier, Elisabeth Boulton, Kamiar Aminian, Jeanine Van Ancum, Stefania Bandinelli, Clemens Becker, Ronny Bergquist, Lorenzo Chiari, Lindy Clemson, David P. French, Brenda Gannon, Helen Hawley-Hague, Nini H. Jonkman, Sabato Mellone, Anisoara Paraschiv-Ionescu, Mirjam Pijnappels, Michael Schwenk, Chris Todd & 4 others Fan Bella Yang, Anna Zacchi, Jorunn L. Helbostad, Beatrix Vereijken

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Introduction The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE). Methods and analysis The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm). Ethics and dissemination Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published. Trial registration number NCT03065088; Pre-results.

Original languageEnglish
Article numbere023526
Pages (from-to)1-20
Number of pages20
JournalBMJ Open
Volume9
Issue number3
Early online date20 Mar 2019
DOIs
Publication statusPublished - 20 Mar 2019

Fingerprint

Life Style
Young Adult
Randomized Controlled Trials
Exercise
Muscle Strength
Norway
Random Allocation
Health Promotion
Ethics
Netherlands
Germany
Registries
Guidelines
Delivery of Health Care
Control Groups
Population
Therapeutics

Keywords

  • balance
  • behaviour change
  • functional decline
  • mobile health units
  • muscle strength
  • physical activity

Cite this

Taraldsen, K., Stefanie Mikolaizak, A., Maier, A. B., Boulton, E., Aminian, K., Van Ancum, J., ... Vereijken, B. (2019). Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults. BMJ Open, 9(3), 1-20. [e023526]. https://doi.org/10.1136/bmjopen-2018-023526
Taraldsen, Kristin ; Stefanie Mikolaizak, A. ; Maier, Andrea B. ; Boulton, Elisabeth ; Aminian, Kamiar ; Van Ancum, Jeanine ; Bandinelli, Stefania ; Becker, Clemens ; Bergquist, Ronny ; Chiari, Lorenzo ; Clemson, Lindy ; French, David P. ; Gannon, Brenda ; Hawley-Hague, Helen ; Jonkman, Nini H. ; Mellone, Sabato ; Paraschiv-Ionescu, Anisoara ; Pijnappels, Mirjam ; Schwenk, Michael ; Todd, Chris ; Yang, Fan Bella ; Zacchi, Anna ; Helbostad, Jorunn L. ; Vereijken, Beatrix. / Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults. In: BMJ Open. 2019 ; Vol. 9, No. 3. pp. 1-20.
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Taraldsen, K, Stefanie Mikolaizak, A, Maier, AB, Boulton, E, Aminian, K, Van Ancum, J, Bandinelli, S, Becker, C, Bergquist, R, Chiari, L, Clemson, L, French, DP, Gannon, B, Hawley-Hague, H, Jonkman, NH, Mellone, S, Paraschiv-Ionescu, A, Pijnappels, M, Schwenk, M, Todd, C, Yang, FB, Zacchi, A, Helbostad, JL & Vereijken, B 2019, 'Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults' BMJ Open, vol. 9, no. 3, e023526, pp. 1-20. https://doi.org/10.1136/bmjopen-2018-023526

Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults. / Taraldsen, Kristin; Stefanie Mikolaizak, A.; Maier, Andrea B.; Boulton, Elisabeth; Aminian, Kamiar; Van Ancum, Jeanine; Bandinelli, Stefania; Becker, Clemens; Bergquist, Ronny; Chiari, Lorenzo; Clemson, Lindy; French, David P.; Gannon, Brenda; Hawley-Hague, Helen; Jonkman, Nini H.; Mellone, Sabato; Paraschiv-Ionescu, Anisoara; Pijnappels, Mirjam; Schwenk, Michael; Todd, Chris; Yang, Fan Bella; Zacchi, Anna; Helbostad, Jorunn L.; Vereijken, Beatrix.

In: BMJ Open, Vol. 9, No. 3, e023526, 20.03.2019, p. 1-20.

Research output: Contribution to JournalArticleAcademicpeer-review

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T1 - Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults

AU - Taraldsen, Kristin

AU - Stefanie Mikolaizak, A.

AU - Maier, Andrea B.

AU - Boulton, Elisabeth

AU - Aminian, Kamiar

AU - Van Ancum, Jeanine

AU - Bandinelli, Stefania

AU - Becker, Clemens

AU - Bergquist, Ronny

AU - Chiari, Lorenzo

AU - Clemson, Lindy

AU - French, David P.

AU - Gannon, Brenda

AU - Hawley-Hague, Helen

AU - Jonkman, Nini H.

AU - Mellone, Sabato

AU - Paraschiv-Ionescu, Anisoara

AU - Pijnappels, Mirjam

AU - Schwenk, Michael

AU - Todd, Chris

AU - Yang, Fan Bella

AU - Zacchi, Anna

AU - Helbostad, Jorunn L.

AU - Vereijken, Beatrix

PY - 2019/3/20

Y1 - 2019/3/20

N2 - Introduction The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE). Methods and analysis The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm). Ethics and dissemination Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published. Trial registration number NCT03065088; Pre-results.

AB - Introduction The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE). Methods and analysis The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm). Ethics and dissemination Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published. Trial registration number NCT03065088; Pre-results.

KW - balance

KW - behaviour change

KW - functional decline

KW - mobile health units

KW - muscle strength

KW - physical activity

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