The PreventIT Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions
- Conditions
- Young Older Adults
- Interventions
- Behavioral: aLIFEBehavioral: eLIFEBehavioral: control
- Registration Number
- NCT03065088
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description aLiFE aLIFE 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. eLiFE eLIFE 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. control control The control group follows the World Health Organization's recommendations of physical activity.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Static balance Change; baseline, 6 months and 12 months Assessed by the Eight Level Balance 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
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 Short Form Quality of Life (SF-12)
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)
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 EuroQol - EQ-5D-5L
Cost-effectiveness Baseline, 6 months, and 12 month follow up Incremental cost-effectiveness ratios (ICERs)
Accelerometer Collected duration 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
Cognitive function Change; baseline, 6 months and 12 months assessed by the Montreal Cognitive Assessment Tool (MoCA)
Instrumented functional strength Change; baseline, 6 months and 12 months Instrumented 30sec chair stand
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 Focus group interview
Process evaluation 12 months Focus group interview
Accelerometer Collected percentages of sedentary 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 duration 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 Telehealthcare Satisfaction Questionnaire
Acceptance of self-administered tests Baseline and 12 month follow up Self-assessment test battery for physical function
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 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
Trial Locations
- Locations (3)
MOVE Research Institute Amsterdam, Amsterdam Center on Aging
🇳🇱Amsterdam, Netherlands
Klinik für Geriatrische Rehabilitation
🇩🇪Stuttgart, Germany
NTNU
🇳🇴Trondheim, Norway