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Completed

NCT Number: NCT02185157

Effects of Dual-task Exercises on Gait Parameters and Cognitive Function in Elderly Women: A Randomized Controlled Trial

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.

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Key information

Conditions

Healthy

Age range

69 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy

Belo Horizonte, Minas Gerais, 31270-901, Brazil

About this study

Socially speaking, the findings could potentially bring important insights regarding the impacts of improvements in walking abilities and cognition. If the elderly maintain safe gait patterns that prevent falls, they could reach self-sustained community participation and consequently reduce the burden of care on the family and caregivers. Additionally, the public health system may ultimately receive important positive economic and social impacts. This clinical trial may be reproduced in research and clinical practice environments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

dual -task exercises

Other

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

Other names: physical exercises, aerobic training, physical activity

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.

Primary outcomes

  1. change of gait stride variability

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

    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.

Secondary outcomes

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

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

    This outcome measure will be assessed by the Brazilian version of the Addenbrooke's Cognitive Examination-Revised (ACE-R) that is a global cognitive assessment instrument with high sensitivity and specificity to detect mild dementia and differentiate frontotemporal dementia from Alzheimer's disease. This instrument assess orientation and attention, memory, verbal fluency, language and visual-spatial skills.

    A maximum score of 100 is calculated from five sub-scores: Orientation and attention (18 points); memory (26 points); verbal fluency (14 points); language (26 points); and visual-spatial skills (16 points) [26]. The validation study of the English version of the ACE-R proposed a cut-off score of 88 points for higher sensitivity (sensitivity 94 %, specificity89 %). A cut-off score of 82 points was proposed for better specificity (specificity: 100 %, sensitivity: 84%), with population-based norms also available for the Brazilian population.

Other outcomes

  1. Changes on Stroop test or the Color-word interference test

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

    This test consists of two tasks. For the first task, the participants are asked to name, as fast as possible, the color seen in a square with various color circles. Then, the same colors are shown as written words, instead of the circles. However, the colors are printed in an incongruent way, that is, the word is written in red, but the color is yellow and the participant should be able to identify the color, and not read the word. The examiner takes note of the time and the number of mistakes. The Stroop effect is said to be the difference between the time of execution of the first and the second tasks. Both the time, in minutes, and the number of errors will be registered for analyses.

  2. Changes on Trail making test

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

    The trail making test is a classic executive function test and several studies have shown the relationships between its scores with gait abilities. Overall, the test assesses the time to execute visual-motor tasks, as a dimension of a cognitive flexibility test.The test includes two parts:The first consists of drawing a simple line that requires that the individual links numbers 1 to 25, consecutively.The second requires the same consecutive number linking, but now have the interference of letters, so that the linkage is made by alternating letters and numbers. It is also a time-measured test and the time, in minutes, to conclude both parts, will be registered for analyses.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Effects of Dual-task Versus Aerobic Training on Gait Stride Variability and Cognitive Function of Independent Community-dwelling Elderly Women: A Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2014
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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