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

Norwegian University of Science and Technology180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Conditions

Young Older Adults

Interventions

aLIFEBEHAVIORAL

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.

eLIFEBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 61 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Klinik für Geriatrische Rehabilitation

Stuttgart, Germany

MOVE Research Institute Amsterdam, Amsterdam Center on Aging

Amsterdam, Netherlands

NTNU

Trondheim, Norway