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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-08-31

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.

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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:

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.

Conditions

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Young Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Assessors are blinded to group allocation

Study Groups

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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.

Group Type EXPERIMENTAL

aLIFE

Intervention Type 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

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.

Group Type EXPERIMENTAL

eLIFE

Intervention Type 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

The control group follows the World Health Organization's recommendations of physical activity.

Group Type ACTIVE_COMPARATOR

control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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:

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

Minimum Eligible Age

61 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No