Effect of a Dual-task Intervention Program on Physical and Cognitive Function

Fragility Clinical Trial

Official title:

Effect of a Dual-task Intervention Program on Physical and Cognitive Function in Institutionalized Older Adults: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06361615
• Other study ID #: CEC_FP_2023042
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Conversion Disorder
• Fragility
• Functional Movement Disorder
• Movement Disorders

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