Young Older Adults
Conditions
Keywords
Exercise, Feasibility Studies, Healthy Lifestyle, Health Promotion, Health Behavior, Aging, Activities of Daily Living, Mobile Applications
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.
Interventions
BEHAVIORALaLIFE
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.
BEHAVIORALeLIFE
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.
BEHAVIORALcontrol
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.
Sponsors
VU University of Amsterdam
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
University of Bologna
University of Manchester
Local Centre Health Unit Tuscany
Ecole Polytechnique Fédérale de Lausanne
Doxee S.p.A.
Health Leads BV
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors are blinded to group allocation
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.
Eligibility
Sex/Gender
ALL
Age
61 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported function and disability | Change; baseline, 6 months and 12 months | Measured using the Late-Life Function and Disability Instrument (LLFDI) |
| Behavioural complexity metric | Change; baseline, 6 months and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | Change; baseline, 6 months and 12 months | will be measured by the JAMAR dynamometer (kg) |
| Functional Leg Strength | Change; baseline, 6 months and 12 months | assessed by the 5-chair stand |
| Balance and mobility | Change; baseline, 6 months and 12 months | Assessed by the Community Balance and Mobility Scale (CB&M) |
| Cognitive function | Change; baseline, 6 months and 12 months | assessed by the Montreal Cognitive Assessment Tool (MoCA) |
| Mood | Change; baseline, 6 months and 12 months | Self-reported by use of the Center for Epidemiologic Studies Depression Scale (CES-D) |
| Fear of falling | Change; baseline, 6 months and 12 months | short Falls Efficacy Scale-International (short FESI) |
| Health related quality of life | Change; baseline, 6 months and 12 months | as assessed by the EuroQol - EQ-5D-5L |
| Instrumented functional strength | Change; baseline, 6 months and 12 months | Instrumented 30sec chair stand |
| Instrumented standing balance | Change; baseline, 6 months and 12 months | Instrumented Static balance |
| Instrumented mobility | Change; baseline, 6 months and 12 months | Instrumented Time up and go test (iTUG) |
| Number of participants completing the different parts of the study | Screening, baseline, 6 months, and 12 months follow up | Flow of participants during the study (number of completers and drop outs at different phases of the study) |
| Adverse Events | Through study completion, an average of 12 months | Numbers, description, and severity reported by the assessors and instructors |
| Experience with the interventions, including motivation and behaviour change | Baseline, 6 months, and 12 month follow up | 7-point Likert Scale |
| Process evaluation | 12 months | Focus group interview |
| Static balance | Change; baseline, 6 months and 12 months | Assessed by the Eight Level Balance Scale |
| Attendance and adherence intervention | From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months | Single question every four week (email or mail) |
| Quality Adjusted Life Years (QALYs) | Baseline, 6 months, and 12 month follow up | Short Form Quality of Life (SF-12) |
| Cost-effectiveness | Baseline, 6 months, and 12 month follow up | Incremental cost-effectiveness ratios (ICERs) |
| Acceptance of self-administered tests | Baseline and 12 month follow up | Self-assessment test battery for physical function |
| Accelerometer Collected percentages of sedentary time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected duration of sedentary time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected percentages of walking time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected duration of walking time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected percentages of active time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected duration of active time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days | Change; baseline, 6 months and 12 months | Objectively measured by activity monitors |
| Technology evaluation | 6 months and 12 month follow up | the System Usability Scale |
| Gait speed | Change; baseline, 6 months and 12 months | will be measured during a 4 m walk at usual pace and 7m walk at usual and fast pace |
Countries
Germany, Netherlands, Norway
Outcome results
None listed