The PreventIT Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions

NCT03065088 | Completed DMC

• 1 other identifier: 2016/1891
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 3

Brief Summary

The feasibility randomised controlled trial is part of the EU funded project "PreventIT" (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21: Advancing active and healthy ageing with ICT: Early risk detection and intervention. The PreventIT project focuses on a new behaviour change activity approach for young older adults (61-70 years of age) with an overall aim of early prevention of functional decline and to empower people to take care of their own health.

Conditions

Young Older Adults

Keywords

Exercise; Feasibility Studies; Healthy Lifestyle; Health Promotion; Health Behavior; Aging; Activities of Daily Living; Mobile Applications

Outcome Measures

Primary Outcomes (2)

• Self-reported function and disability

  Measured using the Late-Life Function and Disability Instrument (LLFDI)

  Change; baseline, 6 months and 12 months

• Behavioural complexity metric

  A composite measure of physical activity, sleep, and social participation, measured by a unitless scale. Physical activity and sleep is objectively measured by activity monitors worn at the lower back and the wrist, while social interaction is assessed as phone calls.

  Change; baseline, 6 months and 12 months

Secondary Outcomes (34)

• Balance and mobility

  Change; baseline, 6 months and 12 months

• Static balance

  Change; baseline, 6 months and 12 months

• Gait speed

  Change; baseline, 6 months and 12 months

• Grip Strength

  Change; baseline, 6 months and 12 months

• Functional Leg Strength

  Change; baseline, 6 months and 12 months

Study Arms (3)

aLiFE

EXPERIMENTAL

The aLiFE programme is developed for young older adults, where balance activities, strengthening activities, and specific recommendations for increasing physical activity, are embedded within everyday activities, so that the activities can be performed multiple times throughout the day. The programme is presented by an instructor by use of a paper based manual during a 6 month intervention period in participants homes.

Behavioral: aLIFE

eLiFE

EXPERIMENTAL

The aLiFE programme is transferred to a mobile health system, called the eLiFE. The intervention is delivered on smartphones and smartwatches including inertial sensors well suited to monitor physical activity and movement quality in daily life. An instructor teaches the participants how to use the mobile health system during home visits and phone calls during the 6 month intervention period. A virtual instructor teaches the participants the eLiFE programme. Pictures and videos of the aLiFE activities are delivered by use of the system. Behavioural change strategies are also included in the system.

Behavioral: eLIFE

control

ACTIVE COMPARATOR

The control group follows the World Health Organization's recommendations of physical activity.

Behavioral: control

Interventions

aLIFE BEHAVIORAL

The aLiFE programme is taught by an instructor during six home visits and 3 phone calls during the 6-month intervention period. The programme will be personalised by use of an initial balance and strength assessment (aLiFE assessment tool). The participants assigns activities to his or her daily activities, and during subsequent home visits, the number of activities and task demands are upgraded. Participants will be taught how to select opportunities themselves to embed activities into their individual daily routine, and how to progress over time.

aLiFE

eLIFE BEHAVIORAL

The eLIFE includes a personalised ICT-administered training schedule using the activities developed in aLiFE, delivered in the form of video clips, pictures and text/verbal instructions on a smartphone and smartwatch application. Personalisation of activity content will be decided based on a phenotype tool and initial difficulty level is decided through the aLiFE assessment tool. In addition, a virtual instructor teaches the participants how to carry out the eLiFE programme. The user receives motivational messages and feedback, and there will be a possibility for social interaction between the participants. The instructors teach the eLiFE participants the programme during 4 home visits and 3 phone calls during the 6 month intervention period.

eLiFE

control BEHAVIORAL

The control group follows the World Health Organization's recommendations of physical activity. The control participants will receive one home visit and be given a written letter with the activity recommendations.

control

Eligibility Criteria

• Age: 61 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• born in the years 1947-1956
• Retired (more than 6 months, \<50% paid/unpaid work)
• Home-dwelling
• Able to read newspaper or text on smartphone
• Speak Norwegian/Dutch/German
• Able to walk 500 m without walking aids
• Available for home visits the following 6 weeks
• Defined "at risk" for functional decline by the risk screening instrument developed in the PreventIT project

You may not qualify if:

• Current participation in an organised exercise class \>1 per week or moderate-intensity physical activity ≥150 min/week in the previous 3 months
• Travels planned \>2mths during follow-up
• Cognitive impairment (MOCA \<24 points)
• Medical conditions:
• Heart failure New York Heart Function Assessment (NYHA) class III and IV
• Acute myocardial infarction last 6 months or unstable angina
• Pericarditis, myocarditis, endocarditis in the last 6 months
• Symptomatic aortic stenosis
• Cardiomyopathy
• Resting blood pressures of a systolic \>180 or diastolic \>100 or higher
• Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
• Uncontrolled Asthma (at least 2 exacerbation in the last 6 months)
• Amputated lower extremities
• On active cancer treatment during last 6 months
• Ankylosing spondylitis

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• VU University of Amsterdam: collaborator
• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): collaborator
• University of Bologna: collaborator
• University of Manchester: collaborator
• Local Centre Health Unit Tuscany: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Doxee S.p.A.: collaborator
• Health Leads BV: collaborator

Study Sites (3)

Klinik für Geriatrische Rehabilitation

Stuttgart, Germany

Location

MOVE Research Institute Amsterdam, Amsterdam Center on Aging

Amsterdam, Netherlands

Location

NTNU

Trondheim, Norway

Location

Related Publications (4)

• Taraldsen K, Mikolaizak AS, 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. Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults. BMJ Open. 2019 Mar 20;9(3):e023526. doi: 10.1136/bmjopen-2018-023526.

  PMID: 30898801 BACKGROUND

• Mikolaizak AS, Taraldsen K, Boulton E, Gordt K, Maier AB, Mellone S, Hawley-Hague H, Aminian K, Chiari L, Paraschiv-Ionescu A, Pijnappels M, Todd C, Vereijken B, Helbostad JL, Becker C. Impact of adherence to a lifestyle-integrated programme on physical function and behavioural complexity in young older adults at risk of functional decline: a multicentre RCT secondary analysis. BMJ Open. 2022 Oct 5;12(10):e054229. doi: 10.1136/bmjopen-2021-054229.

  PMID: 36198449 DERIVED

• Taraldsen K, Mikolaizak AS, Maier AB, Mellone S, Boulton E, Aminian K, Becker C, Chiari L, Follestad T, Gannon B, Paraschiv-Ionescu A, Pijnappels M, Saltvedt I, Schwenk M, Todd C, Yang FB, Zacchi A, van Ancum J, Vereijken B, Helbostad JL. Digital Technology to Deliver a Lifestyle-Integrated Exercise Intervention in Young Seniors-The PreventIT Feasibility Randomized Controlled Trial. Front Digit Health. 2020 Jul 31;2:10. doi: 10.3389/fdgth.2020.00010. eCollection 2020.

  PMID: 34713023 DERIVED

• Gordt K, Nerz C, Mikolaizak AS, Taraldsen K, Pijnappels M, Helbostad JL, Vereijken B, Becker C, Schwenk M. Sensitivity to Change and Responsiveness of the Original and the Shortened Version of the Community Balance and Mobility Scale for Young Seniors. Arch Phys Med Rehabil. 2021 Nov;102(11):2102-2108. doi: 10.1016/j.apmr.2021.03.036. Epub 2021 Apr 29.

  PMID: 33932360 DERIVED

MeSH Terms

Conditions

Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jorunn Helbostad, phd prof

  Norwegian Universitiy of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blinded to group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility study run as a randomised controlled trial (RCT). This is a multi-centre trial with three centres, Trondheim, Amsterdam, and Stuttgart, with two behaviour change exercise programmes (aLiFE and eLiFE) and a control group, with a 6 months intervention period and 6 month follow up.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 27, 2017
• Study Start: February 28, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1); NO (1)