Healthy AgingNCT05296551
Dual-task Training in Older Adults
A study testing Motor Task and Cognitive-motor dual-task in people with Healthy Aging, run by George Washington University at 1 site in United States.
Trial summary
This study seeks to understand what factors influence the capacity to perform simultaneous motor and cognitive tasks in older adults to improve movement throughout their community with the least risk of injury. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Motor Task and Cognitive-motor dual-task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 5 May 2024
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 60 and 95 Years Old
- Self-described as generally healthy
- Normal or corrected to normal vision
- Able to stand on one foot for at least 3 seconds with minimal sway and no loss of balance
Who cannot join
- Known neurologic disorder affecting mobility or cognition
- Self-reported known moderate or greater lower extremity arthritis
- Known disease process that affects muscle function
- Color Blindness
- Lower extremity pain in the previous 15 days
- Known learning or attention deficit
Show all 10Show fewer
- Currently taking medication that affects attention, learning, and/or memory
- Known Cardiovascular Disease of previous heart attack or cardiomyopathy
- Chronic Kidney Disease
- Severe Obesity as defined by a BMI of greater than or equal to 40 Kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University, Department of Health, Human Function and Rehabilitation Science
Washington D.C., District of Columbia, 20006
About this study
Official title: Examination of a Novel Cognitive-motor Weight-bearing Dual-task Intervention in Older Adults
This study seeks to understand what factors influence the capacity to perform simultaneous motor and cognitive tasks in older adults to improve movement throughout their community with the least risk of injury. To function in the real world, one needs to "walk and talk", or to move about the community while attending to their environment. Navigating a busy environment becomes increasingly difficult due to the multitude of constraints placed on the organism by both the brain and the body that are associated with aging. Resulting lack of movement causes a downward spiral; further decreasing function and increasing risk of co-morbidities. This will impose an enormous cost on our healthcare system as the elderly population continues to grow in the United States. The investigators aim to investigate both cognitive and movement changes during aging to prevent declines in functional mobility. The investigators will do this through eight weeks training of simultaneous cognitive and motor tasks (cognitive-motor training).
Read the detailed description
In order to functionally move through one's community, it is vital to be able to perform simultaneous motor and cognitive tasks (cognitive-motor dual-task). This allows us to talk to another person, scan the environment for oncoming traffic, and avoid objects that are in our path when walking. This even allows high level sporting participation, such as predicting an opponents' path when sprinting and cutting to score a goal. Unfortunately, aging is associated with increased difficulty in performing cognitive-motor tasks. A classical example is when older adults stop walking in order to talk to another person. Several studies have established that an increase in age is associated with increased cognitive resources required to perform normally automatic motor tasks. Deficits in cognitive-motor dual-task capabilities have been observed not only in older adults, but also in those with neuromuscular compromise due to factors such as stroke and Parkinson's, and even with altered cognition in mild cognitive impairment and Attention Deficit Disorder.
Although these early investigations suggest a relationship between physical and cognitive capabilities, little is known regarding the appropriate level of cognitive task difficulty that will result in improvements or delays in learning a motor task. Conflicting results are noted in the few studies that have investigated this line of research. Some support that a concurrent cognitive task provides a context that facilitates motor learning, while other show that cognitive load prevents individuals from fully learning the motor task . Further, there are very few studies that investigate the effect of cognitive load on the transfer of motor learning to new task conditions for weight-bearing activities. Early evidence suggests that generalizability of learning diminishes the further participants are from the initial task conditions. Interestingly, cognition has been suggested to play a vital role in motor learning, performance, and dual-task capability. Working memory capacity, or the process that allows the maintenance and manipulation of information over a short period of time, has been shown to strongly relate to the rate at which younger adults learn motor sequences, and moderately relate the motor learning of older adults. Executive function, or the properties of cognitive flexibility, problem-solving, and response maintenance, also plays a role in motor learning and performance. Decrements in executive function has been shown to precede mobility limitations, and might even predict gains in mobility from a physical intervention. Executive function may also predict a large portion of the variability when under the context of simultaneously having a cognitive load. There continues to be a lack of understanding of what cognitive capacity is required to perform simultaneous mobility and cognitive tasks with the least risk of injury, and what dose of intervention in both physical and cognitive realms are necessary to induce an improvement in function of both systems.
Purpose: To determine the impact an intervention using simultaneous cognitive and motor tasks on the capacity of healthy adults to improve in functional mobility and cognition.
Research Question: Does a cognitive-motor intervention impact functional mobility and cognition of healthy older adults?
Following obtaining consent from the subject, testing will take place three times a week for 8 weeks. Subjects are randomly assigned to one of each of the three groups: control group, simple cognitive group, or complex cognitive group.
Subjects will be informed that they are randomly assigned to one of three possible groups. Subjects will then be asked to perform either a visuomotor task only (control group), or a visuomotor task with a simultaneous cognitive task (simple cognitive group and complex cognitive group). The visuomotor task is the same regardless of group assignment. The difference in intervention between groups is based on the simultaneous task that the individual will perform: the control group will perform no cognitive task, the simple cognitive group will perform a task of counting a defined letter that appears on the screen, and the complex cognitive group will be assigned the task of counting two assigned letters that appear on the screen. The visuomotor task consists of performing a standing in-place march, lifting alternating knees to 60 degrees of hip flexion, eight cycles on each leg. A custom computer program displays a real-time video of the individual on the screen with an overlay of markers indicating computerized detection (Microsoft Kinect) of the knee joint. A prescribed marching rate is determined by an ellipse on the screen that prescribes the displacement (degrees of hip flexion) and rate of movement (speed) in which to move. Subjects will be allowed light touch for balance if required. One minute of seated rest will be provided between trials with the option of longer rest as needed. Video of the subject is saved in a de-identified format consisting of the view of the individual on the screen and the target task only during the duration of each individual trial. The cognitive task is displayed on the same screen as the motor task. Letters of different orientations and colors appear and disappear on the screen. Each of the 24 sessions will involve performing approximately 20 trials of the visuomotor and cognitive task (control group: visuomotor task only, intervention groups: visuomotor + cognitive task).
Additional details regarding the visuomotor and cognitive tasks are as follows. On the first day, 13th, and 24th days, subjects will perform 20 training trials at a medium speed of the marching task (training), followed by 5 trials of varying marching speeds (testing) by altering the speed (not the amplitude) of a target ellipse that moves on the screen. Then, subjects will be asked to perform one trial of each the simple and the complex cognitive tasks without performing the marching task (cognitive task only). On days 13, and 24 days, subjects will also perform the 5 testing trials under each of the other groups' cognitive task assignment (e.g. a subject assigned to the simple cognitive task group would first perform 5 training and 5 testing trials while performing the simple cognitive task, they would then perform 5 testing trials with the complex cognitive task followed by 5 trials while only performing the motor task). During all other days of the 24 interventions, subjects will perform 20 trials of the medium speed visuomotor task, performing only the cognitive task required of their assigned group.
Additionally, on the 1st,13th, and 24th day, the investigators will take height, weight, and use a scale that measures the participant's body fat percentage (by standing barefoot on the scale). Subjects will be asked to fill out questionnaires which will include information about medical, physical and social life, cognition, activity level, sleep quality and pain levels (see attached forms). Subjects will then be asked to undergo computerized testing of general cognitive function and perceived health via the NIH Toolbox Cognition Battery and PROMIS (via iPad app), and a paper-based assessment of cognition (Montreal Cognitive Assessment). During the NIH Toolbox Cognition Battery test, subjects will sit comfortably in a chair with their arm resting on a table and will perform four tests: the Flanker Inhibitory Control and Attention Test (FLCAT), The List Sorting Working memory Test (LSWMT), The Dimensional Change Card Sort Test (DCCST), and the Processing Speed Test (PST). The FLCAT, DCCST, and PST tests require the user to select an object on the screen using their finger as quickly as possible; the LSWMT will require no movement, but to recite objects of animals and fruits that appear on the screen of the iPad. The Subjects are free to skip any questions or tests that they would prefer not to answer or complete. A test of balance is performed asking the individual to stand on a pressure sensitive mat (Zeno Mat) to record foot pressures and amount of body sway. They will be asked to stand in place with their 1) eyes open, 2) eyes closed, and 3) performing a cognitive task while standing on each foot (single limb stance). Subjects will then be asked to perform a Timed Up and Go (TUG) test under conditions of performing a cognitive task (TUG Cognitive), and without a secondary task (TUG). The TUG test consists of moving as quickly as possible through standing from sitting, walking 3 meters, turning around, and returning three meters to return to the starting seated position. Each test is usually performed in under 30 seconds. Subjects will then be asked to perform a 10-meter walk test, where in the middle of the 8 meters of self-selected walking, they will walk over a pressure sensitive mat (ZenoMat) to determine properties of gait. The 10m walk test will be perform with and without a simultaneous cognitive task at a speed that they feel is normal for them, and then as quickly as they can walk safely.
On days 1, 2, 13, and 24, the investigators will use wireless electrodes with a disposable adhesive interface will be placed over the alcohol abraded skin of lower extremity muscles in order to collect surface electromyography. Following placement of electrodes subjects will be asked to perform three maximal volitional isometric contraction (MVIC) for each muscle. Each MVIC is achieved by the experimenter applying manual resistance in serial with a hand-held dynamometer at the distal most portion of the segment (leg) to which the muscle attaches. The subject is then provided with verbal encouragement to move the limb being tested in the primary direction of muscle movement (eg. For the quadriceps muscles, resistance is applied to the distal tibia at the level of just proximal to the malleoli during knee extension). Between each maximal effort, 1-min rest will be provided to prevent fatigue.
- Conditions
- Healthy Aging
- Being tested
- Motor Task, Cognitive-motor dual-task
- Keywords
- Dual-Task, Cognitive-Motor Interference, Functional Mobility, Cognition, Motor Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor TaskOther
A visuomotor task is presented where an individual must match their knee to an ellipse that moves up and down on a screen, resulting in a marching-in-place motion at a specified frequency.
Cognitive-motor dual-taskOther
While performing the "Motor Task" intervention, letters of different colors and orientation randomly appear one at a time on the screen. During the Cognitive-motor dual-task, individuals are instructed to count the number of times that either 1 (simple cognitive task), or 2 (complex cognitive task) characters appear on the screen during the motor task.
| Study group | Role | What they receive |
|---|---|---|
| Dual Task One | Experimental | Participants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is simple. Receives: Other: Cognitive-motor dual-task |
| Dual Task Two | Experimental | Participants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is complex. Receives: Other: Cognitive-motor dual-task |
| Control | Active comparator | Participants perform only a motor-task that is the same for all groups (no simultaneous cognitive task). Receives: Other: Motor Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Timed Up and Go Tests in 4 week increments
Timed Up and Go, and Timed Up and Go Cognitive
Measured: Baseline, Week 4, and Week 8
Change in 10 meter walk test self-selected pace in 4 week increments
self selected pace walking over an instrumented mat (ZenoMat) both single task and while counting serial 3's
Measured: Baseline, Week 4, and Week 8
Change in Cognition in 4 week increments
Components of Cognitive Fluidity as measured by the NIH Toolbox Cognitive Battery
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (3)
Balance Test Performance in 4 week increments
Single Leg Stand with and without Cognitive Task
Measured: Baseline, Week 4, and Week 8
change in 10 meter walk test fast pace in 4 week increments
Walking as fast as possible without running an instrumented mat (ZenoMat) both single task and while counting serial 3's
Measured: Baseline, Week 4, and Week 8
Change in Muscle Electromyography in 4 week increments
Surface electromyography (sEMG) will be obtained by placing wireless Delsys Trigno electrodes on the skin over the muscles of the lower extremities (tibialis anterior, lateral gastrocnemius, Rectus Femoris, Vastus Medialis, Lateral Hamstrings, and Gluteus Maximus). EMG will used to measure muscle activity during the cognitive-motor dual-task in order to measure changes in neuromuscular control strategy as subjects learn to perform the task.
Measured: Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start3 Mar 2022
- Primary completion5 May 2024
- Study completion5 May 2024
Why it stopped: Difficulty in recruitment within a reasonable timeframe. Primary Investigator has also moved institutions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies 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
- Model description
- Subjects are block randomized into 3 parallel groups.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Cole, George Washington University
- Investigators
- Keith Cole, DPT, Ph. D., Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296551
- Sponsor's protocol ID
- NCR213528
- Status last verified
- May 2024
- First submitted
- 5 Mar 2022
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Alcock L, Galna B, Lord S, Rochester L. Characterisation of foot clearance during gait in people with early Parkinson׳s disease: Deficits associated with a dual task. J Biomech. 2016 Sep 6;49(13):2763-2769. doi: 10.1016/j.jbiomech.2016.06.007. Epub 2016 Jun 15.
PubMed 27363617Alvarez JA, Emory E. Executive function and the frontal lobes: a meta-analytic review. Neuropsychol Rev. 2006 Mar;16(1):17-42. doi: 10.1007/s11065-006-9002-x.
PubMed 16794878Alves FD, Souza GC, Biolo A, Clausell N. Comparison of two bioelectrical impedance devices and dual-energy X-ray absorptiometry to evaluate body composition in heart failure. J Hum Nutr Diet. 2014 Dec;27(6):632-8. doi: 10.1111/jhn.12218. Epub 2014 Mar 29.
PubMed 24684316Amboni M, Barone P, Iuppariello L, Lista I, Tranfaglia R, Fasano A, Picillo M, Vitale C, Santangelo G, Agosti V, Iavarone A, Sorrentino G. Gait patterns in Parkinsonian patients with or without mild cognitive impairment. Mov Disord. 2012 Oct;27(12):1536-43. doi: 10.1002/mds.25165. Epub 2012 Oct 2.
PubMed 23032876Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.
PubMed 3809575Baetens T, De Kegel A, Palmans T, Oostra K, Vanderstraeten G, Cambier D. Gait analysis with cognitive-motor dual tasks to distinguish fallers from nonfallers among rehabilitating stroke patients. Arch Phys Med Rehabil. 2013 Apr;94(4):680-6. doi: 10.1016/j.apmr.2012.11.023. Epub 2012 Nov 24.
PubMed 23187040Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
PubMed 20585013Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol (1985). 1986 Jun;60(6):2020-7. doi: 10.1152/jappl.1986.60.6.2020.
PubMed 3087938Bedard P, Song JH. Attention modulates generalization of visuomotor adaptation. J Vis. 2013 Oct 16;13(12):12. doi: 10.1167/13.12.12.
PubMed 24133292Blumen HM, Holtzer R, Brown LL, Gazes Y, Verghese J. Behavioral and neural correlates of imagined walking and walking-while-talking in the elderly. Hum Brain Mapp. 2014 Aug;35(8):4090-104. doi: 10.1002/hbm.22461. Epub 2014 Feb 12.
PubMed 24522972Bo J, Borza V, Seidler RD. Age-related declines in visuospatial working memory correlate with deficits in explicit motor sequence learning. J Neurophysiol. 2009 Nov;102(5):2744-54. doi: 10.1152/jn.00393.2009. Epub 2009 Sep 2.
PubMed 19726728Bo J, Seidler RD. Visuospatial working memory capacity predicts the organization of acquired explicit motor sequences. J Neurophysiol. 2009 Jun;101(6):3116-25. doi: 10.1152/jn.00006.2009. Epub 2009 Apr 8.
PubMed 19357338Bolanowski M, Nilsson BE. Assessment of human body composition using dual-energy x-ray absorptiometry and bioelectrical impedance analysis. Med Sci Monit. 2001 Sep-Oct;7(5):1029-33.
PubMed 11535954Brauer SG, Morris ME. Can people with Parkinson's disease improve dual tasking when walking? Gait Posture. 2010 Feb;31(2):229-33. doi: 10.1016/j.gaitpost.2009.10.011. Epub 2009 Dec 6.
PubMed 19969461
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a Novel Cognitive-motor Weight-bearing Dual-task Intervention in Older Adults
- ClinicalTrials.gov ID
- NCT05296551
- Acronym / sponsor ID
- NCR213528
- Conditions
- Healthy Aging
- Keywords
- Dual-Task, Cognitive-Motor Interference, Functional Mobility, Cognition, Motor Performance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment within a reasonable timeframe. Primary Investigator has also moved institutions.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- 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.
This study seeks to understand what factors influence the capacity to perform simultaneous motor and cognitive tasks in older adults to improve movement throughout their community with the least risk of injury. To function in the real world, one needs to "walk and talk", or to move about the community while attending to their environment. Navigating a busy environment becomes increasingly difficult due to the multitude of constraints placed on the organism by both the brain and the body that are associated with aging. Resulting lack of movement causes a downward spiral; further decreasing function and increasing risk of co-morbidities. This will impose an enormous cost on our healthcare system as the elderly population continues to grow in the United States. The investigators aim to investigate both cognitive and movement changes during aging to prevent declines in functional mobility. The investigators will do this through eight weeks training of simultaneous cognitive and motor tasks (cognitive-motor training).
Detailed description
In order to functionally move through one's community, it is vital to be able to perform simultaneous motor and cognitive tasks (cognitive-motor dual-task). This allows us to talk to another person, scan the environment for oncoming traffic, and avoid objects that are in our path when walking. This even allows high level sporting participation, such as predicting an opponents' path when sprinting and cutting to score a goal. Unfortunately, aging is associated with increased difficulty in performing cognitive-motor tasks. A classical example is when older adults stop walking in order to talk to another person. Several studies have established that an increase in age is associated with increased cognitive resources required to perform normally automatic motor tasks. Deficits in cognitive-motor dual-task capabilities have been observed not only in older adults, but also in those with neuromuscular compromise due to factors such as stroke and Parkinson's, and even with altered cognition in mild cognitive impairment and Attention Deficit Disorder.
Although these early investigations suggest a relationship between physical and cognitive capabilities, little is known regarding the appropriate level of cognitive task difficulty that will result in improvements or delays in learning a motor task. Conflicting results are noted in the few studies that have investigated this line of research. Some support that a concurrent cognitive task provides a context that facilitates motor learning, while other show that cognitive load prevents individuals from fully learning the motor task . Further, there are very few studies that investigate the effect of cognitive load on the transfer of motor learning to new task conditions for weight-bearing activities. Early evidence suggests that generalizability of learning diminishes the further participants are from the initial task conditions. Interestingly, cognition has been suggested to play a vital role in motor learning, performance, and dual-task capability. Working memory capacity, or the process that allows the maintenance and manipulation of information over a short period of time, has been shown to strongly relate to the rate at which younger adults learn motor sequences, and moderately relate the motor learning of older adults. Executive function, or the properties of cognitive flexibility, problem-solving, and response maintenance, also plays a role in motor learning and performance. Decrements in executive function has been shown to precede mobility limitations, and might even predict gains in mobility from a physical intervention. Executive function may also predict a large portion of the variability when under the context of simultaneously having a cognitive load. There continues to be a lack of understanding of what cognitive capacity is required to perform simultaneous mobility and cognitive tasks with the least risk of injury, and what dose of intervention in both physical and cognitive realms are necessary to induce an improvement in function of both systems.
Purpose: To determine the impact an intervention using simultaneous cognitive and motor tasks on the capacity of healthy adults to improve in functional mobility and cognition.
Research Question: Does a cognitive-motor intervention impact functional mobility and cognition of healthy older adults?
Following obtaining consent from the subject, testing will take place three times a week for 8 weeks. Subjects are randomly assigned to one of each of the three groups: control group, simple cognitive group, or complex cognitive group.
Subjects will be informed that they are randomly assigned to one of three possible groups. Subjects will then be asked to perform either a visuomotor task only (control group), or a visuomotor task with a simultaneous cognitive task (simple cognitive group and complex cognitive group). The visuomotor task is the same regardless of group assignment. The difference in intervention between groups is based on the simultaneous task that the individual will perform: the control group will perform no cognitive task, the simple cognitive group will perform a task of counting a defined letter that appears on the screen, and the complex cognitive group will be assigned the task of counting two assigned letters that appear on the screen. The visuomotor task consists of performing a standing in-place march, lifting alternating knees to 60 degrees of hip flexion, eight cycles on each leg. A custom computer program displays a real-time video of the individual on the screen with an overlay of markers indicating computerized detection (Microsoft Kinect) of the knee joint. A prescribed marching rate is determined by an ellipse on the screen that prescribes the displacement (degrees of hip flexion) and rate of movement (speed) in which to move. Subjects will be allowed light touch for balance if required. One minute of seated rest will be provided between trials with the option of longer rest as needed. Video of the subject is saved in a de-identified format consisting of the view of the individual on the screen and the target task only during the duration of each individual trial. The cognitive task is displayed on the same screen as the motor task. Letters of different orientations and colors appear and disappear on the screen. Each of the 24 sessions will involve performing approximately 20 trials of the visuomotor and cognitive task (control group: visuomotor task only, intervention groups: visuomotor + cognitive task).
Additional details regarding the visuomotor and cognitive tasks are as follows. On the first day, 13th, and 24th days, subjects will perform 20 training trials at a medium speed of the marching task (training), followed by 5 trials of varying marching speeds (testing) by altering the speed (not the amplitude) of a target ellipse that moves on the screen. Then, subjects will be asked to perform one trial of each the simple and the complex cognitive tasks without performing the marching task (cognitive task only). On days 13, and 24 days, subjects will also perform the 5 testing trials under each of the other groups' cognitive task assignment (e.g. a subject assigned to the simple cognitive task group would first perform 5 training and 5 testing trials while performing the simple cognitive task, they would then perform 5 testing trials with the complex cognitive task followed by 5 trials while only performing the motor task). During all other days of the 24 interventions, subjects will perform 20 trials of the medium speed visuomotor task, performing only the cognitive task required of their assigned group.
Additionally, on the 1st,13th, and 24th day, the investigators will take height, weight, and use a scale that measures the participant's body fat percentage (by standing barefoot on the scale). Subjects will be asked to fill out questionnaires which will include information about medical, physical and social life, cognition, activity level, sleep quality and pain levels (see attached forms). Subjects will then be asked to undergo computerized testing of general cognitive function and perceived health via the NIH Toolbox Cognition Battery and PROMIS (via iPad app), and a paper-based assessment of cognition (Montreal Cognitive Assessment). During the NIH Toolbox Cognition Battery test, subjects will sit comfortably in a chair with their arm resting on a table and will perform four tests: the Flanker Inhibitory Control and Attention Test (FLCAT), The List Sorting Working memory Test (LSWMT), The Dimensional Change Card Sort Test (DCCST), and the Processing Speed Test (PST). The FLCAT, DCCST, and PST tests require the user to select an object on the screen using their finger as quickly as possible; the LSWMT will require no movement, but to recite objects of animals and fruits that appear on the screen of the iPad. The Subjects are free to skip any questions or tests that they would prefer not to answer or complete. A test of balance is performed asking the individual to stand on a pressure sensitive mat (Zeno Mat) to record foot pressures and amount of body sway. They will be asked to stand in place with their 1) eyes open, 2) eyes closed, and 3) performing a cognitive task while standing on each foot (single limb stance). Subjects will then be asked to perform a Timed Up and Go (TUG) test under conditions of performing a cognitive task (TUG Cognitive), and without a secondary task (TUG). The TUG test consists of moving as quickly as possible through standing from sitting, walking 3 meters, turning around, and returning three meters to return to the starting seated position. Each test is usually performed in under 30 seconds. Subjects will then be asked to perform a 10-meter walk test, where in the middle of the 8 meters of self-selected walking, they will walk over a pressure sensitive mat (ZenoMat) to determine properties of gait. The 10m walk test will be perform with and without a simultaneous cognitive task at a speed that they feel is normal for them, and then as quickly as they can walk safely.
On days 1, 2, 13, and 24, the investigators will use wireless electrodes with a disposable adhesive interface will be placed over the alcohol abraded skin of lower extremity muscles in order to collect surface electromyography. Following placement of electrodes subjects will be asked to perform three maximal volitional isometric contraction (MVIC) for each muscle. Each MVIC is achieved by the experimenter applying manual resistance in serial with a hand-held dynamometer at the distal most portion of the segment (leg) to which the muscle attaches. The subject is then provided with verbal encouragement to move the limb being tested in the primary direction of muscle movement (eg. For the quadriceps muscles, resistance is applied to the distal tibia at the level of just proximal to the malleoli during knee extension). Between each maximal effort, 1-min rest will be provided to prevent fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects are block randomized into 3 parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Dual Task One | Experimental | Other: Cognitive-motor dual-taskParticipants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is simple. |
| Dual Task Two | Experimental | Other: Cognitive-motor dual-taskParticipants perform a cognitive-motor dual-task where the motor task is the same for all groups and the simultaneously performed cognitive task is complex. |
| Control | Active comparator | Other: Motor TaskParticipants perform only a motor-task that is the same for all groups (no simultaneous cognitive task). |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 60 and 95 Years Old
- Self-described as generally healthy
- Normal or corrected to normal vision
- Able to stand on one foot for at least 3 seconds with minimal sway and no loss of balance
Key exclusion criteria (10 listed)
- Known neurologic disorder affecting mobility or cognition
- Self-reported known moderate or greater lower extremity arthritis
- Known disease process that affects muscle function
- Color Blindness
- Lower extremity pain in the previous 15 days
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 |
|---|---|---|
| Motor TaskA visuomotor task is presented where an individual must match their knee to an ellipse that moves up and down on a screen, resulting in a marching-in-place motion at a specified frequency. | Other | Control |
| Cognitive-motor dual-taskWhile performing the "Motor Task" intervention, letters of different colors and orientation randomly appear one at a time on the screen. During the Cognitive-motor dual-task, individuals are instructed to count the number of times that either 1 (simple cognitive task), or 2 (complex cognitive task) characters appear on the screen during the motor task. | Other | Dual Task One, Dual Task Two |
Primary outcome
Change in Timed Up and Go Tests in 4 week increments
Time frame: Baseline, Week 4, and Week 8
Timed Up and Go, and Timed Up and Go Cognitive
Change in 10 meter walk test self-selected pace in 4 week increments
Time frame: Baseline, Week 4, and Week 8
self selected pace walking over an instrumented mat (ZenoMat) both single task and while counting serial 3's
Change in Cognition in 4 week increments
Time frame: Baseline, Week 4, and Week 8
Components of Cognitive Fluidity as measured by the NIH Toolbox Cognitive Battery
3 secondary outcomes
Balance Test Performance in 4 week increments
Time frame: Baseline, Week 4, and Week 8
change in 10 meter walk test fast pace in 4 week increments
Time frame: Baseline, Week 4, and Week 8
Change in Muscle Electromyography in 4 week increments
Time frame: Baseline, Week 4 and Week 8
Results and safety
The study was stopped early (reason given: Difficulty in recruitment within a reasonable timeframe. Primary Investigator has also moved institutions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
- Background: PubMed 27363617Alcock L, Galna B, Lord S, Rochester L. Characterisation of foot clearance during gait in people with early Parkinson׳s disease: Deficits associated with a dual task. J Biomech. 2016 Sep 6;49(13):2763-2769. doi: 10.1016/j.jbiomech.2016.06.007. Epub 2016 Jun 15.
- Background: PubMed 16794878Alvarez JA, Emory E. Executive function and the frontal lobes: a meta-analytic review. Neuropsychol Rev. 2006 Mar;16(1):17-42. doi: 10.1007/s11065-006-9002-x.
- Background: PubMed 24684316Alves FD, Souza GC, Biolo A, Clausell N. Comparison of two bioelectrical impedance devices and dual-energy X-ray absorptiometry to evaluate body composition in heart failure. J Hum Nutr Diet. 2014 Dec;27(6):632-8. doi: 10.1111/jhn.12218. Epub 2014 Mar 29.
- Background: PubMed 23032876Amboni M, Barone P, Iuppariello L, Lista I, Tranfaglia R, Fasano A, Picillo M, Vitale C, Santangelo G, Agosti V, Iavarone A, Sorrentino G. Gait patterns in Parkinsonian patients with or without mild cognitive impairment. Mov Disord. 2012 Oct;27(12):1536-43. doi: 10.1002/mds.25165. Epub 2012 Oct 2.
- Background: PubMed 3809575Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.
- Background: PubMed 23187040Baetens T, De Kegel A, Palmans T, Oostra K, Vanderstraeten G, Cambier D. Gait analysis with cognitive-motor dual tasks to distinguish fallers from nonfallers among rehabilitating stroke patients. Arch Phys Med Rehabil. 2013 Apr;94(4):680-6. doi: 10.1016/j.apmr.2012.11.023. Epub 2012 Nov 24.
- Background: PubMed 20585013Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
- Background: PubMed 3087938Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol (1985). 1986 Jun;60(6):2020-7. doi: 10.1152/jappl.1986.60.6.2020.
- Background: PubMed 24133292Bedard P, Song JH. Attention modulates generalization of visuomotor adaptation. J Vis. 2013 Oct 16;13(12):12. doi: 10.1167/13.12.12.
- Background: PubMed 24522972Blumen HM, Holtzer R, Brown LL, Gazes Y, Verghese J. Behavioral and neural correlates of imagined walking and walking-while-talking in the elderly. Hum Brain Mapp. 2014 Aug;35(8):4090-104. doi: 10.1002/hbm.22461. Epub 2014 Feb 12.
- Background: PubMed 19726728Bo J, Borza V, Seidler RD. Age-related declines in visuospatial working memory correlate with deficits in explicit motor sequence learning. J Neurophysiol. 2009 Nov;102(5):2744-54. doi: 10.1152/jn.00393.2009. Epub 2009 Sep 2.
- Individual participant dataSharing planned: No
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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.
Keith Cole, DPT, Ph. D. principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Task and Cognitive-motor dual-task in people with Healthy Aging, run by George Washington University at 1 site in United States.
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 10 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: stopped early, as of the sponsor's last update on 10 May 2024. 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 United States. 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 was stopped early (reason given: Difficulty in recruitment within a reasonable timeframe. Primary Investigator has also moved institutions.). Results are not available in the source record.
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 in Timed Up and Go Tests in 4 week increments (time frame: Baseline, Week 4, and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296551, which also lists 54 linked publications.
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 May 2024.