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

September 27, 2019 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Malaga
      • Torremolinos, Malaga, Spain, 29620
        • Patronato Municipal de deportes de Torremolinos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
follow up detraining effect of multimodal intervention
Other: multimodal intervention
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
Experimental: application smartphone-based group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical activity Questionnaire
Time Frame: up to 8 weeks
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
Time Frame: baseline; 8; 18 and 28 weeks
baseline; 8; 18 and 28 weeks
Social Support and Self efficacy SS/SE AID
Time Frame: baseline; 8; 18 and 28 weeks
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
Time Frame: baseline; 8,18 and 28 weeks
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)
Time Frame: Changes from 8 weeks during follow up 18 and 28 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Antonio I Cuesta Vargas, PhD, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCCSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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