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

Norwegian University of Science and Technology

Status: Completed

Conditions: Young Older Adults

Treatments: Behavioral: control; Behavioral: eLIFE; Behavioral: aLIFE

Study type: Interventional

Funder types: Other

Identifiers

NCT03065088

2016/1891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 61 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 3 patient groups

aLiFE

Experimental group

Description:

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.

Treatment:

Behavioral: aLIFE

eLiFE

Experimental group

Description:

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.

Treatment:

Behavioral: eLIFE

control

Active Comparator group

Description:

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

Treatment:

Behavioral: control