ElderlyNCT02280928
Development and Evaluation of a Home-Based Dual-Task Training Program to Improve Balance Performance for Older Adults
A study testing Balance exercise, Cognitive training and Dual-task cognitive-cognitive training in people with Elderly and Aged, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to (1) develop and test the effectiveness of home-based interventions on dual-task performance in older adults; and (2) determine the generalizability of the four trainings (i.e. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Balance exercise, Cognitive training and Dual-task cognitive-cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to Jul 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to walk at least 10 meters without any assistive device
- Having greater than 16/23 for illiterate persons, greater than 20/30 for primary education level persons, and greater than 23/30 for secondary education level persons on the Mini-Mental State Examination-Thai 2002 (MMSE-Thai2002)
Who cannot join
- Severe neurological problems that could account for possible imbalance such as cerebral vascular accident, Parkinson's disease, transient ischemic attacks, and neuropathy
- Severe musculoskeletal problems that could impact gait such as severe osteoarthritis and active inflammatory joint disease
- Severe cardiopulmonary problems such as asthma and chronic obstructive pulmonary disease
- Visual impairment that cannot be corrected by lenses
- Severe auditory impairment such as deafness
- Depression as scored ≥ 13 by Thai Geriatric Depression Scale (TGDS)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Associated Medical Sciences, Chiang Mai University
Sripoom, Chiang Mai, 50200
About this study
The purpose of this study is to (1) develop and test the effectiveness of home-based interventions on dual-task performance in older adults; and (2) determine the generalizability of the four trainings (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings) to novel tasks.
Read the detailed description
Although, dual-task motor-cognitive training has proven to be more effective in improving dual-task balance performance than traditional single-task motor training, poor evidence of training-related transfer to a novel dual task has been shown. Additionally, another important impediment to the development of intervention to improve dual-task balance performance is that the previous studies have largely focused on training in a laboratory, or clinical setting, often with one-on-one supervision by a therapist or research assistant. Even though the home-based approach is more pragmatic, desirable, and encourages accessibility, no study has been done to examine the efficacy of home-based dual-task training.
Therefore, this study aims to address these gaps in the literature by conducting a home-based program designed to improve dual-task performance with a broader transfer-of-training effects in older adults. Participants will be randomly assigned to one of four groups (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings).
- Being tested
- Balance exercise, Cognitive training, Dual-task cognitive-cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exerciseOther
Balance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation.
Cognitive trainingOther
Cognitive training involves executive function, attention, and working memory. Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills.
Dual-task cognitive-cognitive trainingOther
The Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Single-task motor training group | Experimental | The participants will receive only balance training which will progress from stance activities, to stance activities plus hand manipulation, then gait activities, and finally gait activities plus hand manipulation. Receives: Other: Balance exercise |
| Single-task cognitive training group | Experimental | The participants will receive cognitive training that will involve executive function, attention, and working memory. Receives: Other: Cognitive training |
| Dual-task motor-cognitive training group | Experimental | The participants assigned to the dual-task motor-cognitive training group will receive the same exercises as single-task motor training while simultaneously performing secondary tasks as those in the single-task cognitive training group. Receives: Other: Balance exercise; Other: Cognitive training |
| Dual-task cognitive-cognitive training group | Experimental | The participants in the dual-task cognitive-cognitive trainings group will receive two cognitive tasks at the same time. Receives: Other: Dual-task cognitive-cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Center of Mass velocity and Base of Support distance
The Center of Mass velocity and Base of Support distance is referred as the direction of the center of mass velocity in relation to base of support. It is used to measure the control of dynamic balance throughout gait under single-task and dual-task conditions in order to examine training effect.
Measured: At baseline and after 4-week training
Spatio-temporal gait parameters
Spatio-temporal gait parameters is measured throughout gait under single-task and dual-task conditions in order to examine training effect.
Measured: At baseline and after 4-week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patima Silsupadol, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280928
- Sponsor's protocol ID
- The graduate school, CMU
- Status last verified
- Jul 2015
- First submitted
- 30 Oct 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Home-Based Dual-Task Training Program to Improve Balance Performance for Older Adults
- ClinicalTrials.gov ID
- NCT02280928
- Acronym / sponsor ID
- The graduate school, CMU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Nov 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 purpose of this study is to (1) develop and test the effectiveness of home-based interventions on dual-task performance in older adults; and (2) determine the generalizability of the four trainings (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings) to novel tasks.
Detailed description
Although, dual-task motor-cognitive training has proven to be more effective in improving dual-task balance performance than traditional single-task motor training, poor evidence of training-related transfer to a novel dual task has been shown. Additionally, another important impediment to the development of intervention to improve dual-task balance performance is that the previous studies have largely focused on training in a laboratory, or clinical setting, often with one-on-one supervision by a therapist or research assistant. Even though the home-based approach is more pragmatic, desirable, and encourages accessibility, no study has been done to examine the efficacy of home-based dual-task training.
Therefore, this study aims to address these gaps in the literature by conducting a home-based program designed to improve dual-task performance with a broader transfer-of-training effects in older adults. Participants will be randomly assigned to one of four groups (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-task motor training group | Experimental | Other: Balance exerciseThe participants will receive only balance training which will progress from stance activities, to stance activities plus hand manipulation, then gait activities, and finally gait activities plus hand manipulation. |
| Single-task cognitive training group | Experimental | Other: Cognitive trainingThe participants will receive cognitive training that will involve executive function, attention, and working memory. |
| Dual-task motor-cognitive training group | Experimental | Other: Balance exercise, Other: Cognitive trainingThe participants assigned to the dual-task motor-cognitive training group will receive the same exercises as single-task motor training while simultaneously performing secondary tasks as those in the single-task cognitive training group. |
| Dual-task cognitive-cognitive training group | Experimental | Other: Dual-task cognitive-cognitive trainingThe participants in the dual-task cognitive-cognitive trainings group will receive two cognitive tasks at the same time. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to walk at least 10 meters without any assistive device
- Having greater than 16/23 for illiterate persons, greater than 20/30 for primary education level persons, and greater than 23/30 for secondary education level persons on the Mini-Mental State Examination-Thai 2002 (MMSE-Thai2002)
Key exclusion criteria (6 listed)
- Severe neurological problems that could account for possible imbalance such as cerebral vascular accident, Parkinson's disease, transient ischemic attacks, and neuropathy
- Severe musculoskeletal problems that could impact gait such as severe osteoarthritis and active inflammatory joint disease
- Severe cardiopulmonary problems such as asthma and chronic obstructive pulmonary disease
- Visual impairment that cannot be corrected by lenses
- Severe auditory impairment such as deafness
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 |
|---|---|---|
| Balance exerciseBalance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation. | Other | Dual-task motor-cognitive training group, Single-task motor training group |
| Cognitive trainingCognitive training involves executive function, attention, and working memory. Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills. | Other | Dual-task motor-cognitive training group, Single-task cognitive training group |
| Dual-task cognitive-cognitive trainingThe Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time. | Other | Dual-task cognitive-cognitive training group |
Primary outcome
The Center of Mass velocity and Base of Support distance
Time frame: At baseline and after 4-week training
The Center of Mass velocity and Base of Support distance is referred as the direction of the center of mass velocity in relation to base of support. It is used to measure the control of dynamic balance throughout gait under single-task and dual-task conditions in order to examine training effect.
Spatio-temporal gait parameters
Time frame: At baseline and after 4-week training
Spatio-temporal gait parameters is measured throughout gait under single-task and dual-task conditions in order to examine training effect.
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 22 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercise, Cognitive training and Dual-task cognitive-cognitive training in people with Elderly and Aged, run by Chiang Mai University at 1 site in Thailand.
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 2 inclusion and 6 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 22 Jul 2015. 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 Thailand. 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?
The Center of Mass velocity and Base of Support distance (time frame: At baseline and after 4-week training). The study lists 2 primary outcomes in all. 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 22 Jul 2015.