NCT02185157

Brief Summary

The training of a secondary task while walking, whether it is reasoning activities, memory or motor tasks, may enhance automation, walking performance, and postural control and, thus, minimize the risk of falls influenced by the walking patterns variability. However, the literature is scarce regarding the influence of dual-task training on changes in gait parameters. The purpose of this prospective, blinded randomized controlled trial is to compare the short- and long-term effects of dual-task and aerobic training on gait stride variability and superior cerebral functions of independent community-dwelling elderly women. The participants will be randomly allocated into either experimental or control groups.The experimental group will undertake 50 minutes/day of dual-task training, three times/week over 12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the outcome measures.The interventions will be delivered by trained physical therapists. Primary outcome will include gait stride variability, which will be assessed by a movement analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal and fast speeds. Secondary outcome measures will include a battery of global and specific cognitive function tests. The findings of this trial may help better understand whether cognitive-motor interventions with older adults, when compared to traditional aerobic training, would result in greater improvements in gait under dual-task conditions and lead to improvements in cognitive tasks. Furthermore, the findings could potentially bring important insights regarding the impacts of improvements in walking abilities and cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable healthy

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

October 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

July 2, 2014

Last Update Submit

July 6, 2014

Conditions

Keywords

elderlydual-task trainingaerobic traininggaitcognition

Outcome Measures

Primary Outcomes (1)

  • change of gait stride variability

    The change in gait stride variability will be measured by a movement analysis system: The GaitRite® system that gives another gait parameters as speed, step width, double support, etc.

    Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study

Secondary Outcomes (1)

  • Changes on the Executive function measured by Addenbrooke's Cognitive Examination-Revised (ACE-R)

    baseline, at the sixth week as a intermediary measure, final and three months after the end of study months later

Other Outcomes (2)

  • Changes on Stroop test or the Color-word interference test

    Baseline,at the sixth week as a intermediary measure, final and three months after the end of the study

  • Changes on Trail making test

    Baseline, at the sixth week as a intermediary measure, final and three months after the end of the study

Study Arms (2)

Experimental: Dual Task exercises

EXPERIMENTAL

Dual-task training, includes 18 sessions model of cognitive and 12 motor dual-task exercises model, were administered in groups of four participants in a comfortable environment, without distraction effects. The 50-minute sessions included 30 minutes of motor dual-task exercises, and then, the participants were divided into pairs. The first pair performed free walks during 10 minutes at their maximal speeds, while the other received individual cognitive dual-task training for the same time, and these activities will be exchanged, so that all pairs could walk and receive cognitive training.

Other: dual -task exercises

Control intervention: Aerobic training

OTHER

The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.

Other: Aerobic training

Interventions

physical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms.

Also known as: physical exercises, aerobic training, physical activity
Experimental: Dual Task exercises

The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.

Control intervention: Aerobic training

Eligibility Criteria

Age69 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly women will be eligible if they are between 69 and 79 years of age, have at least three years of schooling,have no cognitive deficits, as determined by the scores on the Mini-Mental State Examination, adjusted for their education levels: ≥23 for three years, ≥25 for four to seven years, and ≥26 for eight or more years of school.

You may not qualify if:

  • Participants will be excluded if they have neuromusculoskeletal diseases,which could restrain physical activities or make use of medications, which could interfere with motor performance and/or memory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gisele C. Gomes, Master

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 9, 2014

Study Start

October 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations