Functional Movement DisorderNCT06361615
Effect of a Dual-task Intervention Program on Physical and Cognitive Function
A study testing Single-Task and Dual-Task in people with Functional Movement Disorder and Fragility, run by University of Americas - Chili at 1 site in Chile.
Trial summary
Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month. Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive… Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Functional Movement Disorder, Fragility
- What is being tested?
- Single-Task and Dual-Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- 8 Nov 2023to 5 Apr 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Institutionalized older people between 65 and 75
- mild to moderate cognitive impairment
Who cannot join
- Acute or chronic pathologies that prevent exercise
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de las Americas
Santiago, Santiago Metropolitan, 7750495
About this study
Official title: Effect of a Dual-task Intervention Program on Physical and Cognitive Function in Institutionalized Older Adults: a Randomized Clinical Trial
Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.
Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions.
- Conditions
- Functional Movement Disorder, Fragility
- Being tested
- Single-Task, Dual-Task
- Keywords
- dual task exercise, institutionalized, physical function
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-TaskOther
Single-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol. This exercise program has been published previously12, which considered 15 different exercises in a functional exercise circuit.
Dual-TaskOther
DT training (multicomponent physical exercise + cognitive tasks)
| Study group | Role | What they receive |
|---|---|---|
| Simple-Task (multicomponent physical exercise) | Active comparator | Single-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol Receives: Other: Single-Task |
| Dual-Task training (multicomponent physical exercise + cognitive tasks) | Experimental | Dual-task (DT) training group performed motor (FEC) plus cognitive tasks Receives: Other: Dual-Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
The SPPB is a battery of tests that include: the 4-meter walking test (4MWT) performed at usual pace, the 5-times sit-to-stand test (5STS), and Romberg balance test, assessing the ability of standing upright in three progressively standing conditions (feet together, semi-tandem and full-tandem) for a maximum period of ten seconds. SPPB scores range from 0 (inability to complete the test) to 4 (best performance), obtaining a total score ranging from 0 (worst performance) to 12 (best performance)14.
Measured: 4 weeks
Secondary outcomes (4)
Montreal Cognitive Assessment (MoCA)
MoCA15 was used to assess cognitive status. This test evaluates older adults' attention, language, calculation, orientation, construction, visual and memory. This test has been validated in Spanish16and has cut-off scores adjusted to the Chilean population17. maximum score is 30 points, where 26 points or more is considered normal
Measured: 4 weeks
Barthel Index
Disability status was assessed by the Barthel Index18. This test measures the individual's independence in Basic Activities of Daily Living (BADLs). Barthel Index classifies individuals in four categories: severe disability (scores from 0 to 60), moderate disability (scores from 65 to 85), mild disability (from 90 to 95) and no disability (scores of 100).
Measured: 4 weeks
Isometric Handgrip Strength (IHS)
IHS in both hands were evaluated by using a hydraulic JAMAR dynamometer (J. A. Preston Corporation, Clifton, NJ, USA) following standard procedures19. The best of two performances with one minute of resting between them was registered.
Measured: 4 weeks
Immobility Syndrome Scale
Staging of dismobility was assessed by the tool proposed by Dinamarca (ETADI) 20. ETADI tries to classify older individuals according to their immobility level: stage 1 corresponds to the level in which the patient can spend most of the day in standing, stage 2, sedentary, and stages 3, 4 and 5 correspond to the substages of bed rest. Sub-stage "A" is related to greater independence and "B" to greater dependence on the patient.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start8 Nov 2023
- Primary completion5 Mar 2024
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Movement DisorderStudies 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Astudillo Ganora, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361615
- Sponsor's protocol ID
- CEC_FP_2023042
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dual-task Intervention Program on Physical and Cognitive Function in Institutionalized Older Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06361615
- Acronym / sponsor ID
- CEC_FP_2023042
- Conditions
- Functional Movement Disorder, Fragility
- Keywords
- dual task exercise, institutionalized, physical function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 12 Apr 2024 (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.
Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.
Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Simple-Task (multicomponent physical exercise) | Active comparator | Other: Single-TaskSingle-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol |
| Dual-Task training (multicomponent physical exercise + cognitive tasks) | Experimental | Other: Dual-TaskDual-task (DT) training group performed motor (FEC) plus cognitive tasks |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Institutionalized older people between 65 and 75
- mild to moderate cognitive impairment
Key exclusion criteria (1 listed)
- Acute or chronic pathologies that prevent exercise
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 |
|---|---|---|
| Single-TaskSingle-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol. This exercise program has been published previously12, which considered 15 different exercises in a functional exercise circuit. | Other | Simple-Task (multicomponent physical exercise) |
| Dual-TaskDT training (multicomponent physical exercise + cognitive tasks) | Other | Dual-Task training (multicomponent physical exercise + cognitive tasks) |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 4 weeks
The SPPB is a battery of tests that include: the 4-meter walking test (4MWT) performed at usual pace, the 5-times sit-to-stand test (5STS), and Romberg balance test, assessing the ability of standing upright in three progressively standing conditions (feet together, semi-tandem and full-tandem) for a maximum period of ten seconds. SPPB scores range from 0 (inability to complete the test) to 4 (best performance), obtaining a total score ranging from 0 (worst performance) to 12 (best performance)14.
4 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 4 weeks
Barthel Index
Time frame: 4 weeks
Isometric Handgrip Strength (IHS)
Time frame: 4 weeks
Immobility Syndrome Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
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 Single-Task and Dual-Task in people with Functional Movement Disorder and Fragility, run by University of Americas - Chili at 1 site in Chile.
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 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: status not confirmed, as of the sponsor's last update on 12 Apr 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 Chile. 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?
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?
Short Physical Performance Battery (SPPB) (time frame: 4 weeks). 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 12 Apr 2024.