Non-sedentaryNCT02235922
Effects of a Dual Task Protocol on Cognition and Functionality in Non-sedentary Older Adults
A study testing Dual task training and Conventional training in people with Non-sedentary, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the effects of a dual task protocol on cognitive domains and functional capacity in non-sedentary older adults. The hypothesis of the present study is that older people undergoing to a dual task exercise protocol have greater benefits on cognition and functional performance… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-sedentary
- What is being tested?
- Dual task training and Conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Aug 2014
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged over 60 years
- community people
- ability to walk alone
- non-sedentary
Who cannot join
- non-realization of any cognitive or functional assessment
- presence of Parkinson's Disease, Dementia and Stroke with motor sequel
- frequency to trainings below 70%
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
The purpose of this study is to analyze the effects of a dual task protocol on cognitive domains and functional capacity in non-sedentary older adults.
The hypothesis of the present study is that older people undergoing to a dual task exercise protocol have greater benefits on cognition and functional performance, compared to a standard exercise protocol.
- Conditions
- Non-sedentary
- Being tested
- Dual task training, Conventional training
- Keywords
- Aged, Exercise, Cognition, Functional capacity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task trainingOther
The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.
Conventional trainingOther
The conventional training consisted of individuals subjected to a multicomponent exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Dual task training | Experimental | Dual task training Receives: Other: Dual task training |
| Conventional training | Experimental | Conventional training Receives: Other: Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on cognition after 3 months of training
Cognition was assessed by Montreal Cognitive Assessment and Mini-Mental State Examination
Measured: Assessed at baseline and after 3 months of training
Changes on functional capacity after 3 months of training
Functional capacity was assessed by Timed up and go test, Timed up and go test associated to a cognitive task and sit to stand test.
Measured: Assessed at baseline and after 3 months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-sedentaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anielle C M Takahashi, Universidade Federal de Sao Carlos
- Investigators
- Anielle Takahashi, doctorate, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235922
- Sponsor's protocol ID
- LAPESI-01
- Status last verified
- Sep 2014
- First submitted
- 6 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dual Task Protocol on Cognition and Functionality in Non-sedentary Older Adults
- ClinicalTrials.gov ID
- NCT02235922
- Acronym / sponsor ID
- LAPESI-01
- Conditions
- Non-sedentary
- Keywords
- Aged, Exercise, Cognition, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 10 Sep 2014 (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.
The purpose of this study is to analyze the effects of a dual task protocol on cognitive domains and functional capacity in non-sedentary older adults.
The hypothesis of the present study is that older people undergoing to a dual task exercise protocol have greater benefits on cognition and functional performance, compared to a standard exercise protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual task training | Experimental | Other: Dual task trainingDual task training |
| Conventional training | Experimental | Other: Conventional trainingConventional training |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged over 60 years
- community people
- ability to walk alone
- non-sedentary
Key exclusion criteria (3 listed)
- non-realization of any cognitive or functional assessment
- presence of Parkinson's Disease, Dementia and Stroke with motor sequel
- frequency to trainings below 70%
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 |
|---|---|---|
| Dual task trainingThe dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks. | Other | Dual task training |
| Conventional trainingThe conventional training consisted of individuals subjected to a multicomponent exercise program. | Other | Conventional training |
Primary outcome
Changes on cognition after 3 months of training
Time frame: Assessed at baseline and after 3 months of training
Cognition was assessed by Montreal Cognitive Assessment and Mini-Mental State Examination
Changes on functional capacity after 3 months of training
Time frame: Assessed at baseline and after 3 months of training
Functional capacity was assessed by Timed up and go test, Timed up and go test associated to a cognitive task and sit to stand test.
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 10 Sep 2014.
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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.
Anielle Takahashi, doctorate principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task training and Conventional training in people with Non-sedentary, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 4 inclusion and 3 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 10 Sep 2014. 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 Brazil. 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?
Changes on cognition after 3 months of training (time frame: Assessed at baseline and after 3 months of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2014.