Clinical trial NCT03065088: The PreventIT Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Young Older Adults
Keywords: Exercise
Feasibility Studies
Healthy Lifestyle
Health Promotion
Health Behavior
Aging
Activities of Daily Living
Mobile Applications
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: University of Bologna
name: University of Manchester
name: Local Centre Health Unit Tuscany
name: Ecole Polytechnique Fédérale de Lausanne
name: Doxee S.p.A.
name: Health Leads BV
First posted: 2017-02-27
Enrollment: 180
Sex: ALL
Minimum age (years): 61
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. Heart failure New York Heart Function Assessment (NYHA) class III and IV
  2. Acute myocardial infarction last 6 months or unstable angina
  3. Pericarditis, myocarditis, endocarditis in the last 6 months
  4. Symptomatic aortic stenosis
  5. Cardiomyopathy
  6. Resting blood pressures of a systolic \>180 or diastolic \>100 or higher
  7. Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
  8. Uncontrolled Asthma (at least 2 exacerbation in the last 6 months)
  9. Amputated lower extremities
  10. On active cancer treatment during last 6 months
  11. Ankylosing spondylitis
  12. History of schizophrenia
  13. Parkinsons disease
  14. Recently diagnosed Cerebrovascular Accident (\<6 months)
  15. Epilepsy (treated with medication)
  16. Severe rheumatic arthritis interfering with mobility
  17. Fracture of lumbar spine / thoracic spine or lower extremity in the last 6 months
  18. 3 fractures in the last 2 years due to severe osteoporosis

Primary outcomes:
measure: Self-reported function and disability
timeFrame: Change; baseline, 6 months and 12 months
measure: Behavioural complexity metric
timeFrame: Change; baseline, 6 months and 12 months
Secondary outcomes:
measure: Balance and mobility
timeFrame: Change; baseline, 6 months and 12 months
measure: Static balance
timeFrame: Change; baseline, 6 months and 12 months
measure: Gait speed
timeFrame: Change; baseline, 6 months and 12 months
measure: Grip Strength
timeFrame: Change; baseline, 6 months and 12 months
measure: Functional Leg Strength
timeFrame: Change; baseline, 6 months and 12 months
measure: Cognitive function
timeFrame: Change; baseline, 6 months and 12 months
measure: Mood
timeFrame: Change; baseline, 6 months and 12 months
measure: Fear of falling
timeFrame: Change; baseline, 6 months and 12 months
measure: Health related quality of life
timeFrame: Change; baseline, 6 months and 12 months
measure: Health related quality of life
timeFrame: Change; baseline, 6 months and 12 months
measure: Instrumented functional strength
timeFrame: Change; baseline, 6 months and 12 months
measure: Instrumented standing balance
timeFrame: Change; baseline, 6 months and 12 months
measure: Instrumented mobility
timeFrame: Change; baseline, 6 months and 12 months
measure: Number of participants completing the different parts of the study
timeFrame: Screening, baseline, 6 months, and 12 months follow up
measure: Adverse Events
timeFrame: Through study completion, an average of 12 months
measure: Experience with the interventions, including motivation and behaviour change
timeFrame: Baseline, 6 months, and 12 month follow up
measure: Experience with the interventions, including motivation and behaviour change
timeFrame: Baseline, 6 months, and 12 month follow up
measure: Process evaluation
timeFrame: 12 months
measure: Technology evaluation
timeFrame: 6 months and 12 month follow up
measure: Technology evaluation
timeFrame: 6 months and 12 month follow up
measure: Attendance and adherence intervention
timeFrame: From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months
measure: Quality Adjusted Life Years (QALYs)
timeFrame: Baseline, 6 months, and 12 month follow up
measure: Quality Adjusted Life Years (QALYs)
timeFrame: Baseline, 6 months, and 12 month follow up
measure: Cost-effectiveness
timeFrame: Baseline, 6 months, and 12 month follow up
measure: Acceptance of self-administered tests
timeFrame: Baseline and 12 month follow up
measure: Accelerometer Collected percentages of sedentary time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected duration of sedentary time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected percentages of walking time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected duration of walking time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected percentages of active time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected duration of active time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
measure: Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days
timeFrame: Change; baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Klinik für Geriatrische Rehabilitation
city: Amsterdam
country: Netherlands
facility: MOVE Research Institute Amsterdam, Amsterdam Center on Aging
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: Norwegian Universitiy of Science and Technology
name: Jorunn Helbostad, phd prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.