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Young Older AdultsPreventITNCT03065088

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

A study testing aLIFE and eLIFE in people with Young Older Adults, run by Norwegian University of Science and Technology at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 61 to 70 years
Conditions the study is for
Young Older Adults
What is being tested?
aLIFE and eLIFE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
3 sitesin 3 countries
Study dates
28 Feb 2017to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • History of schizophrenia
  • Parkinsons disease
  • Recently diagnosed Cerebrovascular Accident (<6 months)
  • Epilepsy (treated with medication)
  • Severe rheumatic arthritis interfering with mobility
  • Fracture of lumbar spine / thoracic spine or lower extremity in the last 6 months
  • 3 fractures in the last 2 years due to severe osteoporosis

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Germany1 site

  • Klinik für Geriatrische Rehabilitation

    Stuttgart

Other trials in Germany

Netherlands1 site

  • MOVE Research Institute Amsterdam, Amsterdam Center on Aging

    Amsterdam

Other trials in Netherlands

Norway1 site

  • NTNU

    Trondheim

Other trials in Norway

About this study

Official title: The PreventIT Feasibility Randomised Controlled Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions Delivered by Use of ICT or an Instructor, With a Control Group

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.

Read the detailed description

In this feasibility randomised controlled trial two interventions are compared with a control group. The aLiFE programme includes instructor and paper manual delivery of life-style integrated activities, while the eLiFE programme delivers the same activities by use of smartphone and smartwatch applications. The control group is asked to follow the World Health Organisation's physical activity recommendations.

The main aim is to assess feasibility of the aLiFE and eLiFE programmes and a second aim to suggest sample size and design for a future Phase III clinical trial.

OBJECTIVES: How is the feasibility of having young older adults (between 61-70 years) to perform the aLiFE and eLiFE interventions.

Specifically:

  1. Participation: How is the adherence of specific activities and to the entire aLiFE and eLiFE interventions of young older adults?
  2. Technology: How is the feasibility and usability of the eLiFE intervention delivered using smartphones and smartwatches as platform, regarding user interface, goal setting, feedback, motivational messages, and social interaction?
  3. Outcome measures: How is the risk reduction of functional decline, measured by the Later Life Function and Disability Instrument and behavioural complexity, for the aLiFE and the eLiFE interventions compared to a control group, and what are the estimates of effect sizes for the primary and secondary study outcome measure?
  4. Health economics evaluation: Is it feasible to collect data on, and estimate, health care resource utilization, costs and quality-adjusted life years (QALYs), and model incremental cost-effectiveness ratios (ICERs) of aLiFE, eLiFE compared with the control group over a 6-month, 12-month, and 24-month time horizon?

The study is approved by the three ethical sites prior to study start.

(October 3rd, 2017) The final Data Analysis Plan has been closed before the start of the first post-test assessment in the PreventIT feasibility RCT, starting on the 4th of October 2017.

Being tested
aLIFE, eLIFE, control
Keywords
Exercise, Feasibility Studies, Healthy Lifestyle, Health Promotion, Health Behavior, Aging, Activities of Daily Living, Mobile Applications
Medical subject headings
Motor Activity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aLIFEBehavioural

    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.

  • eLIFEBehavioural

    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.

  • controlBehavioural

    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.

Study groups in NCT03065088
Study groupRoleWhat they receive
aLiFEExperimentalThe 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.
Receives: Behavioral: aLIFE
eLiFEExperimentalThe 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.
Receives: Behavioral: eLIFE
controlActive comparatorThe control group follows the World Health Organization's recommendations of physical activity.
Receives: Behavioral: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported function and disability

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

    Measured: Change; baseline, 6 months and 12 months

  2. 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.

    Measured: Change; baseline, 6 months and 12 months

Secondary outcomes (34)

  1. Balance and mobility

    Assessed by the Community Balance and Mobility Scale (CB\&M)

    Measured: Change; baseline, 6 months and 12 months

  2. Static balance

    Assessed by the Eight Level Balance Scale

    Measured: Change; baseline, 6 months and 12 months

  3. Gait speed

    will be measured during a 4 m walk at usual pace and 7m walk at usual and fast pace

    Measured: Change; baseline, 6 months and 12 months

  4. Grip Strength

    will be measured by the JAMAR dynamometer (kg)

    Measured: Change; baseline, 6 months and 12 months

  5. Functional Leg Strength

    assessed by the 5-chair stand

    Measured: Change; baseline, 6 months and 12 months

  6. Cognitive function

    assessed by the Montreal Cognitive Assessment Tool (MoCA)

    Measured: Change; baseline, 6 months and 12 months

  7. Mood

    Self-reported by use of the Center for Epidemiologic Studies Depression Scale (CES-D)

    Measured: Change; baseline, 6 months and 12 months

  8. Fear of falling

    short Falls Efficacy Scale-International (short FESI)

    Measured: Change; baseline, 6 months and 12 months

  9. Health related quality of life

    as assessed by the EuroQol - EQ-5D-5L

    Measured: Change; baseline, 6 months and 12 months

  10. Health related quality of life

    as assessed by the Short Form Quality of Life (SF-12)

    Measured: Change; baseline, 6 months and 12 months

  11. Instrumented functional strength

    Instrumented 30sec chair stand

    Measured: Change; baseline, 6 months and 12 months

  12. Instrumented standing balance

    Instrumented Static balance

    Measured: Change; baseline, 6 months and 12 months

  13. Instrumented mobility

    Instrumented Time up and go test (iTUG)

    Measured: Change; baseline, 6 months and 12 months

  14. Number of participants completing the different parts of the study

    Flow of participants during the study (number of completers and drop outs at different phases of the study)

    Measured: Screening, baseline, 6 months, and 12 months follow up

  15. Adverse Events

    Numbers, description, and severity reported by the assessors and instructors

    Measured: Through study completion, an average of 12 months

  16. Experience with the interventions, including motivation and behaviour change

    7-point Likert Scale

    Measured: Baseline, 6 months, and 12 month follow up

  17. Experience with the interventions, including motivation and behaviour change

    Focus group interview

    Measured: Baseline, 6 months, and 12 month follow up

  18. Process evaluation

    Focus group interview

    Measured: 12 months

  19. Technology evaluation

    the System Usability Scale

    Measured: 6 months and 12 month follow up

  20. Technology evaluation

    the Telehealthcare Satisfaction Questionnaire

    Measured: 6 months and 12 month follow up

  21. Attendance and adherence intervention

    Single question every four week (email or mail)

    Measured: From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months

  22. Quality Adjusted Life Years (QALYs)

    Short Form Quality of Life (SF-12)

    Measured: Baseline, 6 months, and 12 month follow up

  23. Quality Adjusted Life Years (QALYs)

    EuroQol - EQ-5D-5L

    Measured: Baseline, 6 months, and 12 month follow up

  24. Cost-effectiveness

    Incremental cost-effectiveness ratios (ICERs)

    Measured: Baseline, 6 months, and 12 month follow up

  25. Acceptance of self-administered tests

    Self-assessment test battery for physical function

    Measured: Baseline and 12 month follow up

  26. Accelerometer Collected percentages of sedentary time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  27. Accelerometer Collected duration of sedentary time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  28. Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  29. Accelerometer Collected percentages of walking time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  30. Accelerometer Collected duration of walking time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  31. Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  32. Accelerometer Collected percentages of active time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  33. Accelerometer Collected duration of active time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

  34. Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days

    Objectively measured by activity monitors

    Measured: Change; baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2017
  2. Study start28 Feb 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03065088
Sponsor's protocol ID
2016/1891
Acronym
PreventIT
Status last verified
Mar 2019
First submitted
14 Feb 2017
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30898801

  • 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.

    PubMed 36198449

  • 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.

    PubMed 34713023

  • 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.

    PubMed 33932360

Questions about this trial

What is this clinical trial studying?

A study testing aLIFE and eLIFE in people with Young Older Adults, run by Norwegian University of Science and Technology at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported function and disability (time frame: Change; baseline, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03065088, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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