AgingNCT02621697
Dual Task in Institutionalized Elderly
A study testing Cognitive motor training and kinesiotherapeutic conventional treatment in people with Aging, run by Universidade Federal do Triangulo Mineiro.
Trial summary
Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in the risk of falls, balance, independence in basic activities of daily living (BADL) and handgrip in institutionalized elderly. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cognitive motor training and kinesiotherapeutic conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Feb 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals over the age of 60,
- minimum score of 18 points on the Mini-Mental State Examination (MMSE),
- individuals classified as sedentary according the International Physical Activity Questionnaire (short version IPAQ-),
- literate and visual acuity preserved or corrected.
Who cannot join
- Individuals unable to remain standing upright
- individuals dependent from auxiliary device to walk
- those who performed another type of physical therapy intervention concomitantly
About this study
Official title: Dual Task in Institutionalized Elderly: Positive Impact on the Risk of Falls and Functionality
Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in the risk of falls, balance, independence in basic activities of daily living (BADL) and handgrip in institutionalized elderly.
Methods: The sample was divided in two groups: double task group (DTG), consists of five elderly, undergoing a training consists of motor and cognitive activities and control group (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based on global stretching and strengthening exercises, both held in 16 sessions.
Read the detailed description
Experimental, prospective and quantitative study, whose sample was selected for convenience in a long-term care institution for the elderly (LTCF) in the city of Uberaba - MG. The volunteers were divided into two groups, named dual task group (DTG) consists of five seniors, and control group (CG) consists of four elderly. All participants of both groups answered a questionnaire with sociodemographic and economic characteristics of the sample. Participants underwent a pre- and post evaluation containing vital signs parameters (blood pressure, respiratory rate and heart rate), anthropometric data (weight and height) and different tests to evaluate the balance, functional mobility, risk of falls, muscle strength and independence to carry out basic activities of daily living. The performed tests were Timed Up and Go (TUG) conventional, motor TUG and TUG cognitive, beyond Romberg test and Sensitized Romberg, Berg Balance Scale, and modified Katz scale (with maintenance of the six original activities of the scale, but with simulation to the performance of each task, measuring the spent time).
- Conditions
- Aging
- Being tested
- Cognitive motor training, kinesiotherapeutic conventional treatment
- Keywords
- dual task, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive motor trainingOther
Initially an intervention consisting of double duty activities (motor-cognitive) and the control group will be subjected to a conventional treatment based on stretching and strengthening will be held.
kinesiotherapeutic conventional treatmentOther
Standardized global stretching and strengthening with squat exercise, plantar flexion in foot and elbow flexion supporting body weight in the hands arranged on the wall
| Study group | Role | What they receive |
|---|---|---|
| Cognitive motor training | Experimental | Evaluate the effectiveness of a 12-week training based on dual-task (motor and cognitive) in institutionalized elderly. Receives: Other: Cognitive motor training |
| Control Group | Active comparator | kinesiotherapeutic conventional treatment Receives: Other: kinesiotherapeutic conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of falls
Measured by the following tests: TUG, motor TUG, cognitive TUG, Romberg and sensitized Romberg (all measured in seconds)
Measured: 8 weeks of training
Secondary outcomes (2)
Independence to carry out basic activities of daily living
Through the modified Katz scale: the simulation of the activities originally present in the Katz scale was performed by the participants, and the time taken to their execution was recorded.
Measured: 8 weeks of training
Muscle strength
Through dynamometry
Measured: 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lislei Jorge Patrizzi, Universidade Federal do Triangulo Mineiro
- Investigators
- Lislei Patrizzi, Professor, Principal investigator, Universidade Federal do Triângulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621697
- Sponsor's protocol ID
- UFTM 2015
- Status last verified
- Dec 2015
- First submitted
- 14 Aug 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Task in Institutionalized Elderly: Positive Impact on the Risk of Falls and Functionality
- ClinicalTrials.gov ID
- NCT02621697
- Acronym / sponsor ID
- UFTM 2015
- Conditions
- Aging
- Keywords
- dual task, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Dec 2015 (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.
Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in the risk of falls, balance, independence in basic activities of daily living (BADL) and handgrip in institutionalized elderly.
Methods: The sample was divided in two groups: double task group (DTG), consists of five elderly, undergoing a training consists of motor and cognitive activities and control group (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based on global stretching and strengthening exercises, both held in 16 sessions.
Detailed description
Experimental, prospective and quantitative study, whose sample was selected for convenience in a long-term care institution for the elderly (LTCF) in the city of Uberaba - MG. The volunteers were divided into two groups, named dual task group (DTG) consists of five seniors, and control group (CG) consists of four elderly. All participants of both groups answered a questionnaire with sociodemographic and economic characteristics of the sample. Participants underwent a pre- and post evaluation containing vital signs parameters (blood pressure, respiratory rate and heart rate), anthropometric data (weight and height) and different tests to evaluate the balance, functional mobility, risk of falls, muscle strength and independence to carry out basic activities of daily living. The performed tests were Timed Up and Go (TUG) conventional, motor TUG and TUG cognitive, beyond Romberg test and Sensitized Romberg, Berg Balance Scale, and modified Katz scale (with maintenance of the six original activities of the scale, but with simulation to the performance of each task, measuring the spent time).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive motor training | Experimental | Other: Cognitive motor trainingEvaluate the effectiveness of a 12-week training based on dual-task (motor and cognitive) in institutionalized elderly. |
| Control Group | Active comparator | Other: kinesiotherapeutic conventional treatmentkinesiotherapeutic conventional treatment |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals over the age of 60,
- minimum score of 18 points on the Mini-Mental State Examination (MMSE),
- individuals classified as sedentary according the International Physical Activity Questionnaire (short version IPAQ-),
- literate and visual acuity preserved or corrected.
Key exclusion criteria (3 listed)
- Individuals unable to remain standing upright
- individuals dependent from auxiliary device to walk
- those who performed another type of physical therapy intervention concomitantly
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 |
|---|---|---|
| Cognitive motor trainingInitially an intervention consisting of double duty activities (motor-cognitive) and the control group will be subjected to a conventional treatment based on stretching and strengthening will be held. | Other | Cognitive motor training |
| kinesiotherapeutic conventional treatmentStandardized global stretching and strengthening with squat exercise, plantar flexion in foot and elbow flexion supporting body weight in the hands arranged on the wall | Other | Control Group |
Primary outcome
Risk of falls
Time frame: 8 weeks of training
Measured by the following tests: TUG, motor TUG, cognitive TUG, Romberg and sensitized Romberg (all measured in seconds)
2 secondary outcomes
Independence to carry out basic activities of daily living
Time frame: 8 weeks of training
Muscle strength
Time frame: 8 weeks of training
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 3 Dec 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.
Lislei Patrizzi, Professor principal investigator
Universidade Federal do Triângulo Mineiro
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive motor training and kinesiotherapeutic conventional treatment in people with Aging, run by Universidade Federal do Triangulo Mineiro.
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 3 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Risk of falls (time frame: 8 weeks of training). 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 3 Dec 2015.