|- candidate number||14072|
|- NTR Number||NTR3744|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2012|
|- Secondary IDs||2012-348 METC Erasmus MC|
|- Public Title||Physical activity intervention for adults with ID.|
|- Scientific Title||Effect of a multicomponent intervention to promote physical activity in adults with intellectual disabilities.|
|- ACRONYM||Abrona ACTIEF|
|- hypothesis||This study aims to investigate the effectiveness of a multicomponent intervention in promoting physical activity among adults with ID.|
|- Healt Condition(s) or Problem(s) studied||Physical inactivity, Obesity, Intellectual disabillities|
|- Inclusion criteria||1. Age 18 years and over;|
2. Having an intellectual disability;
3. Receiving residential care from the ID care service Abrona;
4. Informed consent from participant or legal representative.
|- Exclusion criteria||Severe illness.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||5-nov-2012|
|- planned closingdate||31-dec-2013|
|- Target number of participants||116|
|- Interventions||The intervention is called ‘Abrona ACTIEF’, and the letters from the word ‘ACTIEF’ are an acronym of the six components of the multicomponent behavioural intervention. The six components are:|
I: Sharing of Information;
F: Rewards (Dutch: feliciteren).
Participant will first run through a 12 week control period after certain measurements. Tests will be done after these 12 weeks. Participants will then start the intervention, which takes 12 weeks as well.
The intervention contains an educative workshop for the supervisors and participants, two demonstrations of the kind of exercises that can be done, a personal advice, coaching for supervisors and save for a reward together and personally.
|- Primary outcome||1. Physical activity questionnaire for adults with ID (PAQ-ID);|
2. Motion sensor for physical activity monitoring.
|- Secondary outcome||1. Grip strength;|
2. Comfortable Walking speed;
3. 30 sec Chair Stand;
4. 5 times Chair Stand;
6. Waist, hip and calf circumferences;
7. Blood pressure;
8. Attitude of adults with ID towards physical activity behavior;
9. Stages of change and barriers of adults with ID;
10. Fear of falling;
12. Experiences and preferences regarding PA
13. Lawton IADL scale;
14. Mobility questionnaire;
16. Aberrant Behavior Checklist.
|- Timepoints||A repeated-measures design will be used to execute this study: The participants will first undergo a control period of the same length (‘waiting list procedure’) as the intervention period (both 12 weeks). Measurements will take place at the start of the 12-week control period, at the end of the 12-week control period, which is the start of the 12-week intervention period too, at the end of the 12-week intervention period and after a follow-up of three months after the intervention period.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. T.I.M. Hilgenkamp|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T.I.M. Hilgenkamp|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Physical activity levels are very low in adults with intellectual disabilities (ID), and physical activity promotion for the general population is not feasible in this group, due to the specific characteristics of adults with ID and specific characteristics of their support/care setting.
This study aims to investigate the effectiveness of a multicomponent intervention in promoting physical activity among adults with ID.
Quasi-experimental repeated measures design.
Adults with intellectual disabilities, receiving residential care from the ID care service Abrona.
After a control period of 12 weeks, the entire study sample receives the 12-week intervention which aims at changing behavior of adults with ID (increase of physical activity) and changing behaviour of primary care givers (integrate sufficient physical activity in their daily support or care). The intervention starts with a Quickscan, after which the staff and the clients participate in an education session about the relevance of physical activity and possibilities to be active for people with chronic illnesses. The primary care givers receive advice from a physical activity coach, based on the results of the Quickscan. After setting goals for 12 weeks, the physical activity coach continues to coach the primary care givers throughout the process, and visits the living facility twice to demonstrate easy group activities. Participants receive a T-shirt with bag at the start, and a medal and certificate at the end, and the team as a whole collect symbolic euro’s every time a participant completes a Quickscan.
Main study parameters/endpoints:
The primary study parameter is the difference in physical activity of the adults with ID.
|- Main changes (audit trail)|
|- RECORD||7-dec-2012 - 7-jan-2013|