HealthyNCT02185157
Effects of Dual-task Exercises on Gait Parameters and Cognitive Function in Elderly Women: A Randomized Controlled Trial
A study testing dual -task exercises and Aerobic training in people with Healthy, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 69 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dual -task exercises and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Nov 2013
- 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 69 to 79 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- dual -task exercises, Aerobic training
- Keywords
- elderly, dual-task training, aerobic training, gait, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual -task exercisesOther
Also called physical exercises, aerobic training, physical activity
physical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms.
Aerobic trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: baseline, at the sixth week as a intermediary measure, final and three months after the end of study months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisele de Cássia Gomes, Federal University of Minas Gerais
- Investigators
- Gisele C. Gomes, Master, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185157
- Sponsor's protocol ID
- ECAGGOMESUFMG -001
- Other IDs
- CAAE 0448.0.203.000-11
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02185157
- Acronym / sponsor ID
- ECAGGOMESUFMG -001
- Conditions
- Healthy
- Keywords
- elderly, dual-task training, aerobic training, gait, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Jul 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Dual Task exercises | Experimental | Other: dual -task exercisesDual-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. |
| Control intervention: Aerobic training | Other | Other: Aerobic trainingThe 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. |
Who may qualify
- Ages
- 69 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 exercisesAlso: physical exercises, aerobic training, physical activityphysical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms. | Other | Experimental: Dual Task exercises |
| Aerobic trainingThe 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 | Control intervention: Aerobic training |
Primary outcome
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.
1 secondary outcome
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
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 9 Jul 2014.
- UniversityLink provided by the sponsor.
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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.
Gisele C. Gomes, Master principal investigator
Federal University of Minas Gerais
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 exercises and Aerobic training in people with Healthy, run by Federal University of Minas Gerais 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 1 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 9 Jul 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?
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). 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 9 Jul 2014.