NCT02235922

Brief 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, compared to a standard exercise protocol.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 6, 2014

Last Update Submit

September 6, 2014

Conditions

Non-sedentary

Keywords

AgedExerciseCognitionFunctional capacity

Outcome Measures

Primary Outcomes (2)

  • Changes on cognition after 3 months of training

    Cognition was assessed by Montreal Cognitive Assessment and Mini-Mental State Examination

    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.

    Assessed at baseline and after 3 months of training

Study Arms (2)

Dual task training

EXPERIMENTAL

Dual task training

Other: Dual task training

Conventional training

EXPERIMENTAL

Conventional training

Other: Conventional training

Interventions

Dual task trainingOTHER

The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.

Dual task training
Conventional trainingOTHER

The conventional training consisted of individuals subjected to a multicomponent exercise program.

Conventional training

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged over 60 years
  • community people
  • ability to walk alone
  • non-sedentary

You may not qualify if:

  • non-realization of any cognitive or functional assessment
  • presence of Parkinson's Disease, Dementia and Stroke with motor sequel
  • frequency to trainings below 70%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anielle Takahashi, doctorate

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 6, 2014

First Posted

September 10, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

BR(1)