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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03065088
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
VU University of Amsterdam
Robert Bosch Gesellschaft für Medizinische Forschung mbH
University of Bologna
University of Manchester
Local Centre Health Unit Tuscany
Ecole Polytechnique Fédérale de Lausanne
Doxee S.p.A.
Health Leads BV
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Young Older Adults Behavioral: aLIFE Behavioral: eLIFE Behavioral: control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors are blinded to group allocation
Primary Purpose: Prevention
Official 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
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: aLIFE
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.

Experimental: 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.
Behavioral: eLIFE
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.

Active Comparator: control
The control group follows the World Health Organization's recommendations of physical activity.
Behavioral: control
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   61 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065088


Locations
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Germany
Klinik für Geriatrische Rehabilitation
Stuttgart, Germany
Netherlands
MOVE Research Institute Amsterdam, Amsterdam Center on Aging
Amsterdam, Netherlands
Norway
NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
VU University of Amsterdam
Robert Bosch Gesellschaft für Medizinische Forschung mbH
University of Bologna
University of Manchester
Local Centre Health Unit Tuscany
Ecole Polytechnique Fédérale de Lausanne
Doxee S.p.A.
Health Leads BV
Investigators
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Study Director: Jorunn Helbostad, phd prof Norwegian Universitiy of Science and Technology

Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03065088     History of Changes
Other Study ID Numbers: 2016/1891
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Exercise
Feasibility Studies
Healthy Lifestyle
Health Promotion
Health Behavior
Aging
Activities of Daily Living
Mobile Applications