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

Young Older Adults Clinical Trial

— PreventIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065088
• Other study ID #: 2016/1891
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Young Older Adults

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Geriatrische Rehabilitation	Stuttgart
Netherlands	MOVE Research Institute Amsterdam, Amsterdam Center on Aging	Amsterdam
Norway	NTNU	Trondheim

Sponsors (9)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Doxee S.p.A., Ecole Polytechnique Fédérale de Lausanne, Health Leads BV, Local Centre Health Unit Tuscany, Robert Bosch Gesellschaft für Medizinische Forschung mbH, University of Bologna, University of Manchester, VU University of Amsterdam

Countries where clinical trial is conducted

Germany,  Netherlands,  Norway, 

References & Publications (1)

Taraldsen K, Mikolaizak AS, Maier AB, Boulton E, Aminian K, van Ancum J, Bandinelli S, Becker C, Bergquist R, Chiari L, Clemson L, French DP, Gannon B, Hawley-Hague H, Jonkman NH, Mellone S, Paraschiv-Ionescu A, Pijnappels M, Schwenk M, Todd C, Yang FB, Zacchi A, Helbostad JL, Vereijken B. Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults. BMJ Open. 2019 Mar 20;9(3):e023526. doi: 10.1136/bmjopen-2018-023526. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported function and disability	Measured using the Late-Life Function and Disability Instrument (LLFDI)	Change; baseline, 6 months and 12 months
Primary	Behavioural complexity metric	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.	Change; baseline, 6 months and 12 months
Secondary	Balance and mobility	Assessed by the Community Balance and Mobility Scale (CB&M)	Change; baseline, 6 months and 12 months
Secondary	Static balance	Assessed by the Eight Level Balance Scale	Change; baseline, 6 months and 12 months
Secondary	Gait speed	will be measured during a 4 m walk at usual pace and 7m walk at usual and fast pace	Change; baseline, 6 months and 12 months
Secondary	Grip Strength	will be measured by the JAMAR dynamometer (kg)	Change; baseline, 6 months and 12 months
Secondary	Functional Leg Strength	assessed by the 5-chair stand	Change; baseline, 6 months and 12 months
Secondary	Cognitive function	assessed by the Montreal Cognitive Assessment Tool (MoCA)	Change; baseline, 6 months and 12 months
Secondary	Mood	Self-reported by use of the Center for Epidemiologic Studies Depression Scale (CES-D)	Change; baseline, 6 months and 12 months
Secondary	Fear of falling	short Falls Efficacy Scale-International (short FESI)	Change; baseline, 6 months and 12 months
Secondary	Health related quality of life	as assessed by the EuroQol - EQ-5D-5L	Change; baseline, 6 months and 12 months
Secondary	Health related quality of life	as assessed by the Short Form Quality of Life (SF-12)	Change; baseline, 6 months and 12 months
Secondary	Instrumented functional strength	Instrumented 30sec chair stand	Change; baseline, 6 months and 12 months
Secondary	Instrumented standing balance	Instrumented Static balance	Change; baseline, 6 months and 12 months
Secondary	Instrumented mobility	Instrumented Time up and go test (iTUG)	Change; baseline, 6 months and 12 months
Secondary	Number of participants completing the different parts of the study	Flow of participants during the study (number of completers and drop outs at different phases of the study)	Screening, baseline, 6 months, and 12 months follow up
Secondary	Adverse Events	Numbers, description, and severity reported by the assessors and instructors	Through study completion, an average of 12 months
Secondary	Experience with the interventions, including motivation and behaviour change	7-point Likert Scale	Baseline, 6 months, and 12 month follow up
Secondary	Experience with the interventions, including motivation and behaviour change	Focus group interview	Baseline, 6 months, and 12 month follow up
Secondary	Process evaluation	Focus group interview	12 months
Secondary	Technology evaluation	the System Usability Scale	6 months and 12 month follow up
Secondary	Technology evaluation	the Telehealthcare Satisfaction Questionnaire	6 months and 12 month follow up
Secondary	Attendance and adherence intervention	Single question every four week (email or mail)	From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months
Secondary	Quality Adjusted Life Years (QALYs)	Short Form Quality of Life (SF-12)	Baseline, 6 months, and 12 month follow up
Secondary	Quality Adjusted Life Years (QALYs)	EuroQol - EQ-5D-5L	Baseline, 6 months, and 12 month follow up
Secondary	Cost-effectiveness	Incremental cost-effectiveness ratios (ICERs)	Baseline, 6 months, and 12 month follow up
Secondary	Acceptance of self-administered tests	Self-assessment test battery for physical function	Baseline and 12 month follow up
Secondary	Accelerometer Collected percentages of sedentary time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected duration of sedentary time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected percentages of walking time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected duration of walking time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected percentages of active time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected duration of active time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months
Secondary	Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days	Objectively measured by activity monitors	Change; baseline, 6 months and 12 months