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

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
multimodal intervention
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring Intellectual disability, mHealth, App, Physical activity, Adherence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Patronato Municipal de deportes de Torremolinos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

application smartphone-based group

Arm Description

follow up detraining effect of multimodal intervention

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barthel index
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.''
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.
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.

Full Information

First Posted
July 23, 2013
Last Updated
September 27, 2019
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT01915381
Brief Title
Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities
Acronym
APPCOID
Official Title
Improving Adherence Healthy Lifestyle on a Smartphone Based on Complementation Adults With Intellectual Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
Intellectual disability, mHealth, App, Physical activity, Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
follow up detraining effect of multimodal intervention
Arm Title
application smartphone-based group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
multimodal intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
International Physical activity Questionnaire
Description
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.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Barthel index
Time Frame
baseline; 8; 18 and 28 weeks
Title
Social Support and Self efficacy SS/SE AID
Description
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.''
Time Frame
baseline; 8; 18 and 28 weeks
Title
FunFitness
Description
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.
Time Frame
baseline; 8,18 and 28 weeks
Title
Internatioanl Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Changes from 8 weeks during follow up 18 and 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio I Cuesta Vargas, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patronato Municipal de deportes de Torremolinos
City
Torremolinos
State/Province
Malaga
ZIP/Postal Code
29620
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24330604
Citation
Perez-Cruzado D, Cuesta-Vargas AI. Improving Adherence Physical Activity with a Smartphone Application Based on Adults with Intellectual Disabilities (APPCOID). BMC Public Health. 2013 Dec 13;13:1173. doi: 10.1186/1471-2458-13-1173.
Results Reference
derived
Links:
URL
http://www.uma.es
Description
University of Malaga

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

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