NCT01915381

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 30, 2019

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

July 23, 2013

Last Update Submit

September 27, 2019

Conditions

Intellectual Disability

Keywords

Intellectual disabilitymHealthAppPhysical activityAdherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Barthel index

    baseline; 8; 18 and 28 weeks

  • Social Support and Self efficacy SS/SE AID

    baseline; 8; 18 and 28 weeks

  • FunFitness

    baseline; 8,18 and 28 weeks

  • Internatioanl Physical Activity Questionnaire (IPAQ)

    Changes from 8 weeks during follow up 18 and 28 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

follow up detraining effect of multimodal intervention

Other: multimodal intervention

application smartphone-based group

EXPERIMENTAL

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

Interventions

multimodal interventionOTHER

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

Control groupapplication smartphone-based group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were can write and read to ask scales
  • Participant were able to use an Smartphone

You may not qualify if:

  • Physical illness that prevent physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patronato Municipal de deportes de Torremolinos

Torremolinos, Malaga, 29620, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24330604DERIVED

Related Links

MeSH Terms

Conditions

Intellectual DisabilityAlzheimer DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersBehavior

Study Officials

  • Antonio I Cuesta Vargas, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 23, 2013

First Posted

August 2, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2017

Last Updated

September 30, 2019

Record last verified: 2017-02

Locations

ES(1)