Condition category
Not Applicable
Date applied
21/04/2016
Date assigned
03/05/2016
Last edited
26/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A new behaviour change exercise programme named “adapted Lifestyle-integrated Exercise Program (aLiFE)” has been developed within the EU-funded project “PreventIT” (http://www.preventit.eu/). This study aims to evaluate the feasibility of the new aLiFE programme in young older adults aged 60-70.

Who can participate?
Community-dwelling men and women aged 60 to 70

What does the study involve?
The aLiFE programme is delivered by a specialist instructor during 4 home visits. The instructor teaches the participants balance and strength exercises which they can incorporate into their daily life. Participants are also taught to increase their physical activity level. Before and after the intervention participants undergo an assessment of their functional performance. After the intervention, participants are asked about their opinions regarding the aLiFE training.

What are the possible benefits and risks of participating?
Participants may benefit from the intervention in terms of improving their functional performance and increasing their physical activity, although this is not the aim of this study. The aim is to evaluate the participants’ opinions about the programme. The risk of adverse events during aLiFE training is estimated to be low.

Where is the study run from?
1. Robert-Bosch Hospital Stuttgart (Germany)
2. VU University Medical Center Amsterdam (Netherlands)
3. Norwegian University of Science and Technology (Norway)

When is the study starting and how long is it expected to run for?
January 2016 to December 2016

Who is funding the study?
European Commission Horizon 2020

Who is the main contact?
Dr Michael Schwenk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Schwenk

ORCID ID

Contact details

Robert-Bosch-Krankenhaus
Abteilung für Geriatrie und Klinik für Geriatrische Rehabilitation
Auerbachstr. 110
Stuttgart
70376
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Feasibility of the adapted Lifestyle-integrated Exercise (aLiFE) Programme for improving functional performance and increasing physical activity in young older adults: a multicentre pilot study

Acronym

aLiFE pilot

Study hypothesis

Primary hypothesis: a newly developed adapted Lifestyle-integrated Exercise (aLiFE) Programme is feasible and well accepted in a sample of young older adults who are 60 to 70 years of age.

A secondary aim is to test the feasibility of different balance scales in young old adults regarding appropriateness, ceiling effects, and reliability in the target population.

Ethics approval

1. Stuttgart: Ethik-Kommission am Universitätsklinikum Tübingen, 07/04/2016, 033/2016BO2
2. Amsterdam: Medical Ethical Committee, VU University Medical Center, 13/04/2016, NL56456.029.16
3. Trondheim: REC central, anticipated date of approval 29/04/2016, central midt 2016/48

Study design

4-week one-group pre-post test intervention study

Primary study design

Interventional

Secondary study design

Pre-post test

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Preventing functional decline in older adults

Intervention

The adapted Lifestyle-integrated Exercise (aLiFE) programme is an adapted version of the LiFE programme developed by Clemson et al. (BMJ 2012;345:e4547). aLiFE includes strength, balance, and physical activities integrated in everyday life, so that the activities can be performed in natural settings multiple times throughout the day. The aLiFE programme has been specifically adapted to fit people between 60 to 70 year of age.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility of aLiFE as defined by:
1. Willingness to participate
2. Adherence
3. Possible harms
4. Acceptability (rating of helpfulness, safety, level of difficulty, and adaptability)
5. Participants’ views on:
5.1. Planning and engaging in aLiFE activities
5.2. The aLiFE manual
5.3. Support from the trainers
5.4. Their ideas for improving the programme (semi-structured interviews)

Secondary outcome measures

Appropriateness of balance scales in the population of young old adults (ceiling effects, reliability)

Overall trial start date

01/01/2016

Overall trial end date

21/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Community dwelling men and women at age 60 to 70 years

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Inability to walk 500 meters without aid
2. Cognitive impairment (Montreal Cognitive Assessment, MOCA ≥24 points)
3. Existence of severe cardiovascular, pulmonary, neurological, or mental disease where exercise is contraindicated
4. Attending organised exercise classes more than twice a week and/or not exercising more than 2 hours on their own each week

Recruitment start date

01/05/2016

Recruitment end date

31/08/2016

Locations

Countries of recruitment

Germany, Netherlands, Norway

Trial participating centre

Robert-Bosch Hospital Stuttgart
70376
Germany

Trial participating centre

VU University Medical Center Amsterdam
1007
Netherlands

Trial participating centre

Norwegian University of Science and Technology
7491
Norway

Sponsor information

Organisation

Robert-Bosch Hospital Stuttgart (Germany)

Sponsor details

Auerbachstr. 110
Stuttgart
70376
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

European Commission Horizon 2020

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes