Feasibility of the adapted LiFE (aLiFE) intervention – a pilot study
| ISRCTN | ISRCTN37750605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37750605 |
| Secondary identifying numbers | N/A |
- 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
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
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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 |
| 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 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 51 |
| Participant inclusion criteria | Community dwelling men and women at age 60 to 70 years |
| 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 centres
Germany
Netherlands
Norway
Sponsor information
Hospital/treatment centre
Auerbachstr. 110
Stuttgart
70376
Germany
"ROR" |
https://ror.org/034nkkr84 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 21/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| 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 |
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.
