Skip to main content
OpenTrials
Completed

NCT Number: NCT03065088

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Young Older Adults Behavior Health Behavior Motor Activity

Age range

61 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Geriatrische Rehabilitation, Stuttgart, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aLIFE

Behavioral

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.

eLIFE

Behavioral

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.

Control

Behavioral

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.

Primary outcomes

  1. Self-reported function and disability

    Time frame: Change; baseline, 6 months and 12 months

    Measured using the Late-Life Function and Disability Instrument (LLFDI)

  2. Behavioural complexity metric

    Time frame: 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 outcomes

  1. Balance and mobility

    Time frame: Change; baseline, 6 months and 12 months

    Assessed by the Community Balance and Mobility Scale (CB&M)

  2. Static balance

    Time frame: Change; baseline, 6 months and 12 months

    Assessed by the Eight Level Balance Scale

  3. Gait speed

    Time frame: 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

  4. Grip Strength

    Time frame: Change; baseline, 6 months and 12 months

    will be measured by the JAMAR dynamometer (kg)

  5. Functional Leg Strength

    Time frame: Change; baseline, 6 months and 12 months

    assessed by the 5-chair stand

  6. Cognitive function

    Time frame: Change; baseline, 6 months and 12 months

    assessed by the Montreal Cognitive Assessment Tool (MoCA)

  7. Mood

    Time frame: Change; baseline, 6 months and 12 months

    Self-reported by use of the Center for Epidemiologic Studies Depression Scale (CES-D)

  8. Fear of falling

    Time frame: Change; baseline, 6 months and 12 months

    short Falls Efficacy Scale-International (short FESI)

  9. Health related quality of life

    Time frame: Change; baseline, 6 months and 12 months

    as assessed by the EuroQol - EQ-5D-5L

  10. Health related quality of life

    Time frame: Change; baseline, 6 months and 12 months

    as assessed by the Short Form Quality of Life (SF-12)

  11. Instrumented functional strength

    Time frame: Change; baseline, 6 months and 12 months

    Instrumented 30sec chair stand

  12. Instrumented standing balance

    Time frame: Change; baseline, 6 months and 12 months

    Instrumented Static balance

  13. Instrumented mobility

    Time frame: Change; baseline, 6 months and 12 months

    Instrumented Time up and go test (iTUG)

  14. Number of participants completing the different parts of the study

    Time frame: 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)

  15. Adverse Events

    Time frame: Through study completion, an average of 12 months

    Numbers, description, and severity reported by the assessors and instructors

  16. Experience with the interventions, including motivation and behaviour change

    Time frame: Baseline, 6 months, and 12 month follow up

    7-point Likert Scale

  17. Experience with the interventions, including motivation and behaviour change

    Time frame: Baseline, 6 months, and 12 month follow up

    Focus group interview

  18. Process evaluation

    Time frame: 12 months

    Focus group interview

  19. Technology evaluation

    Time frame: 6 months and 12 month follow up

    the System Usability Scale

  20. Technology evaluation

    Time frame: 6 months and 12 month follow up

    the Telehealthcare Satisfaction Questionnaire

  21. Attendance and adherence intervention

    Time frame: 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)

  22. Quality Adjusted Life Years (QALYs)

    Time frame: Baseline, 6 months, and 12 month follow up

    Short Form Quality of Life (SF-12)

  23. Quality Adjusted Life Years (QALYs)

    Time frame: Baseline, 6 months, and 12 month follow up

    EuroQol - EQ-5D-5L

  24. Cost-effectiveness

    Time frame: Baseline, 6 months, and 12 month follow up

    Incremental cost-effectiveness ratios (ICERs)

  25. Acceptance of self-administered tests

    Time frame: Baseline and 12 month follow up

    Self-assessment test battery for physical function

  26. Accelerometer Collected percentages of sedentary time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  27. Accelerometer Collected duration of sedentary time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  28. Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  29. Accelerometer Collected percentages of walking time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  30. Accelerometer Collected duration of walking time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  31. Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  32. Accelerometer Collected percentages of active time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  33. Accelerometer Collected duration of active time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

  34. Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days

    Time frame: Change; baseline, 6 months and 12 months

    Objectively measured by activity monitors

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Doxee S.p.A.
  • Ecole Polytechnique Fédérale de Lausanne
  • Health Leads BV
  • Local Centre Health Unit Tuscany
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
  • University of Bologna
  • University of Manchester
  • VU University of Amsterdam

Registry information

Official study 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

Acronym: PreventIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.