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

Study Overview
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Brief Summary
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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
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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: Participation: How is the adherence of specific activities and to the entire aLiFE and eLiFE interventions of young older adults? 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? 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? 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.

Official Title
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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

Conditions
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Young Older Adults

Intervention / Treatment
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* Behavioral: aLIFE
* Behavioral: eLIFE
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 61 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aLiFE<br>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<br>* 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.<br>|
| Experimental: eLiFE<br>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<br>* 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.<br>|
| Active Comparator: control<br>The control group follows the World Health Organization's recommendations of physical activity. | Behavioral: control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance and mobility | Assessed by the Community Balance and Mobility Scale (CB&M) | Change; baseline, 6 months and 12 months | 
| Static balance | Assessed by the Eight Level Balance Scale | Change; baseline, 6 months and 12 months | 
| Gait speed | will be measured during a 4 m walk at usual pace and 7m walk at usual and fast pace | Change; baseline, 6 months and 12 months | 
| Grip Strength | will be measured by the JAMAR dynamometer (kg) | Change; baseline, 6 months and 12 months | 
| Functional Leg Strength | assessed by the 5-chair stand | Change; baseline, 6 months and 12 months | 
| Cognitive function | assessed by the Montreal Cognitive Assessment Tool (MoCA) | Change; baseline, 6 months and 12 months | 
| Mood | Self-reported by use of the Center for Epidemiologic Studies Depression Scale (CES-D) | Change; baseline, 6 months and 12 months | 
| Fear of falling | short Falls Efficacy Scale-International (short FESI) | Change; baseline, 6 months and 12 months | 
| Health related quality of life | as assessed by the EuroQol - EQ-5D-5L | Change; baseline, 6 months and 12 months | 
| Health related quality of life | as assessed by the Short Form Quality of Life (SF-12) | Change; baseline, 6 months and 12 months | 
| Instrumented functional strength | Instrumented 30sec chair stand | Change; baseline, 6 months and 12 months | 
| Instrumented standing balance | Instrumented Static balance | Change; baseline, 6 months and 12 months | 
| Instrumented mobility | Instrumented Time up and go test (iTUG) | Change; baseline, 6 months and 12 months | 
| 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) | Screening, baseline, 6 months, and 12 months follow up | 
| Adverse Events | Numbers, description, and severity reported by the assessors and instructors | Through study completion, an average of 12 months | 
| Experience with the interventions, including motivation and behaviour change | 7-point Likert Scale | Baseline, 6 months, and 12 month follow up | 
| Experience with the interventions, including motivation and behaviour change | Focus group interview | Baseline, 6 months, and 12 month follow up | 
| Process evaluation | Focus group interview | 12 months | 
| Technology evaluation | the System Usability Scale | 6 months and 12 month follow up | 
| Technology evaluation | the Telehealthcare Satisfaction Questionnaire | 6 months and 12 month follow up | 
| Attendance and adherence intervention | Single question every four week (email or mail) | From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months | 
| Quality Adjusted Life Years (QALYs) | Short Form Quality of Life (SF-12) | Baseline, 6 months, and 12 month follow up | 
| Quality Adjusted Life Years (QALYs) | EuroQol - EQ-5D-5L | Baseline, 6 months, and 12 month follow up | 
| Cost-effectiveness | Incremental cost-effectiveness ratios (ICERs) | Baseline, 6 months, and 12 month follow up | 
| Acceptance of self-administered tests | Self-assessment test battery for physical function | Baseline and 12 month follow up | 
| Accelerometer Collected percentages of sedentary time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected duration of sedentary time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected percentages of walking time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected duration of walking time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected percentages of active time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected duration of active time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 
| Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days | Objectively measured by activity monitors | Change; baseline, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Feasibility Studies, Healthy Lifestyle, Health Promotion, Health Behavior, Aging, Activities of Daily Living, Mobile Applications