Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities

Study Overview
=================
Brief Summary
-----------------
AIM: Improve adherence to physical activity in people with Intellectual disabilities with a Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome

Official Title
-----------------
Improving Adherence Healthy Lifestyle on a Smartphone Based on Complementation Adults With Intellectual Disabilities

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Other: multimodal intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants were can write and read to ask scales Participant were able to use an Smartphone Exclusion Criteria: Physical illness that prevent physical activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>follow up detraining effect of multimodal intervention | Other: multimodal intervention<br>* All subjects received a multimodal intervention consist in a multimodal program with an educational approach, where therapist advice about benefits of PA during the exercises, to promote PA with brochure-based decalogue<br>|
| Experimental: application smartphone-based group<br>Smartphone-based application group (SG) sample will have a reminder to do Phisical activity everyday where patients will have to select if they have done or they haven´t done physical activity. | Other: multimodal intervention<br>* All subjects received a multimodal intervention consist in a multimodal program with an educational approach, where therapist advice about benefits of PA during the exercises, to promote PA with brochure-based decalogue<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical activity Questionnaire | CRAIG, C. L., A. L. MARSHALL, M. SJÖSTRÖM, A. E. BAUMAN, M. L. BOOTH, B. E. AINSWORTH, M. PRATT, U. EKELUND, A. YNGVE, J. F. SALLIS, and P. OJA. International Physical Activity Questionnaire: 12-Country Reliability and Validity. Med. Sci. Sports Exerc., Vol. 35, No. 8, pp. 1381-1395, 2003. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index |  | baseline; 8; 18 and 28 weeks | 
| Social Support and Self efficacy SS/SE AID | The Self-Efficacy and Social Support for Activity for persons with Intellectual Disabilities (SE/SS-AID) scales were developed to measure the relationship between self-efficacy, social support, and physical activity participation for those with ID (Peterson et al., 2009).This modified set of SE/SS-AID scales, composed of 23 questions, and was employed in this study. The Self-Efficacy (SE) scale contained six items, with response options of no, maybe, and yes. Together, the three Social Support (SS) scales included 17 items, which were divided into three subcategories, including six family items, six staff items, and five peers items. The SS scales have response options of ''no, yes - sometimes, and yes - a lot.'' | baseline; 8; 18 and 28 weeks | 
| FunFitness | Funfitness is a battery of 13 fitness tests including: the Passive knee extension test, the Calf muscle flexibility test, the Anterior Hip Flexibility test, the Functional shoulder rotation test, the Timed-stand test, the Partial Sit-up test, the Seated push-up, the Grip test, the Single leg stance open and closed eyes, and the 3 minutes walk test. A detailed description of the tests and data regarding reliability is given Cuesta-Vargas et al Res Dev Disabil. 2011 Mar-Apr;32(2):788-94. doi: 10.1016/j.ridd.2010.10.023. Epub 2010 Dec 15. | baseline; 8,18 and 28 weeks | 
| Internatioanl Physical Activity Questionnaire (IPAQ) | CRAIG, C. L., A. L. MARSHALL, M. SJÖSTRÖM, A. E. BAUMAN, M. L. BOOTH, B. E. AINSWORTH, M. PRATT, U. EKELUND, A. YNGVE, J. F. SALLIS, and P. OJA. International Physical Activity Questionnaire: 12-Country Reliability and Validity. Med. Sci. Sports Exerc., Vol. 35, No. 8, pp. 1381-1395, 2003. | Changes from 8 weeks during follow up 18 and 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
App, Intellectual disability, mHealth, Physical activity, Adherence