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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Community
Study 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
Primary outcome measure
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 study start date
01/01/2016
Overall study end date
21/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Community dwelling men and women at age 60 to 70 years
Participant type(s)
Healthy volunteer
Age group
Senior
Sex
Both
Target number of participants
30
Total final enrolment
51
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
Study participating centre
Robert-Bosch Hospital Stuttgart
70376
Germany
Study participating centre
VU University Medical Center Amsterdam
1007
Netherlands
Study 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
ROR
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
21/12/2017
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/07/2018 | Yes | No | |
| Results article | results | 01/07/2019 | 15/04/2020 | Yes | No |