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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06361615
Other study ID # CEC_FP_2023042
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 8, 2023
Est. completion date April 5, 2024

Study information

Verified date April 2024
Source University of Americas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 24
Est. completion date April 5, 2024
Est. primary completion date March 5, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria: - Institutionalized older people between 65 and 75 - mild to moderate cognitive impairment Exclusion Criteria: - Acute or chronic pathologies that prevent exercise

Study Design


Intervention

Other:
Single-Task
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-Task
DT training (multicomponent physical exercise + cognitive tasks)

Locations

Country Name City State
Chile Universidad de las Americas Santiago de Chile Santiago

Sponsors (1)

Lead Sponsor Collaborator
University of Americas

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Secondary 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 4 weeks
Secondary 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). 4 weeks
Secondary 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. 4 weeks
Secondary 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. 4 weeks
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