Intellectual DisabilityAPPCOIDNCT01915381
Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities
A study testing multimodal intervention in people with Intellectual Disability, run by University of Malaga at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- multimodal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were can write and read to ask scales
- Participant were able to use an Smartphone
Who cannot join
- Physical illness that prevent physical activity
Trial locations and contacts
1 site in 1 country.
Spain1 site
Patronato Municipal de deportes de Torremolinos
Torremolinos, Malaga, 29620
About this study
Official title: 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
- Conditions
- Intellectual Disability
- Being tested
- multimodal intervention
- Keywords
- Intellectual disability, mHealth, App, Physical activity, Adherence
- Medical subject headings
- Intellectual Disability, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | follow up detraining effect of multimodal intervention Receives: 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. Receives: Other: multimodal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 weeks
Secondary outcomes (4)
Barthel index
Measured: 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.''
Measured: 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.
Measured: 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.
Measured: Changes from 8 weeks during follow up 18 and 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio I Cuesta Vargas, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915381
- Sponsor's protocol ID
- FCCSS
- Acronym
- APPCOID
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2013
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24330604
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence Healthy Lifestyle on a Smartphone Based on Complementation Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT01915381
- Acronym / sponsor ID
- APPCOID / FCCSS
- Conditions
- Intellectual Disability
- Keywords
- Intellectual disability, mHealth, App, Physical activity, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: multimodal interventionfollow up detraining effect of multimodal intervention |
| application smartphone-based group | Experimental | Other: multimodal interventionSmartphone-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants were can write and read to ask scales
- Participant were able to use an Smartphone
Key exclusion criteria (1 listed)
- Physical illness that prevent physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal interventionAll 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 | Other | Control group, application smartphone-based group |
Primary outcome
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.
4 secondary outcomes
Barthel index
Time frame: baseline; 8; 18 and 28 weeks
Social Support and Self efficacy SS/SE AID
Time frame: baseline; 8; 18 and 28 weeks
FunFitness
Time frame: baseline; 8,18 and 28 weeks
Internatioanl Physical Activity Questionnaire (IPAQ)
Time frame: Changes from 8 weeks during follow up 18 and 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 24330604Perez-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.
- University of MalagaLink provided by the sponsor.
Related trials for Intellectual Disability
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Recruiting
Contribution of Optical Genome Mapping (OGM) in the Diagnosis of Multiple Congenital Malformations With or Without Intellectual Disability Without Genetic Abnormality
Congenital Malformations
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
RecruitingObservational study
Genome Medical Sequencing for Gene Discovery
Intellectual Disabilities, Congenital Anomaly
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio I Cuesta Vargas, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal intervention in people with Intellectual Disability, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical activity Questionnaire (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.