Feasibility of the adapted LiFE (aLiFE) intervention – a pilot study
| ISRCTN | ISRCTN37750605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37750605 |
| Protocol serial number | N/A |
| Sponsor | Robert-Bosch Hospital Stuttgart (Germany) |
| Funder | European Commission Horizon 2020 |
- Submission date
- 21/04/2016
- Registration date
- 03/05/2016
- Last edited
- 15/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Robert-Bosch-Krankenhaus
Abteilung für Geriatrie und Klinik für Geriatrische Rehabilitation
Auerbachstr. 110
Stuttgart
70376
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 4-week one-group pre-post test intervention study |
| Secondary study design | Pre-post test |
| Study type | Participant information sheet |
| 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 |
| Study acronym | aLiFE pilot |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Feasibility of aLiFE as defined by: |
| Key secondary outcome measure(s) |
Appropriateness of balance scales in the population of young old adults (ceiling effects, reliability) |
| Completion date | 21/12/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 51 |
| Key inclusion criteria | Community dwelling men and women at age 60 to 70 years |
| Key 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 |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- Germany
- Netherlands
- Norway
Study participating centres
Germany
Netherlands
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2018 reference.
05/03/2019: Publication reference added.
12/10/2017: internal review.
