- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361615
Effect of a Dual-task Intervention Program on Physical and Cognitive Function
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santiago
-
Santiago de Chile, Santiago, Chile, 7750495
- Universidad de las Américas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Institutionalized older people between 65 and 75
- mild to moderate cognitive impairment
Exclusion Criteria:
- Acute or chronic pathologies that prevent exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Simple-Task (multicomponent physical exercise)
Single-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol
|
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.
|
|
Experimental: Dual-Task training (multicomponent physical exercise + cognitive tasks)
Dual-task (DT) training group performed motor (FEC) plus cognitive tasks
|
DT training (multicomponent physical exercise + cognitive tasks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 4 weeks
|
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
|
4 weeks
|
|
Barthel Index
Time Frame: 4 weeks
|
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).
|
4 weeks
|
|
Isometric Handgrip Strength (IHS)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
|
Immobility Syndrome Scale
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEC_FP_2023042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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