NCT06361615

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 5, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

dual task exerciseinstitutionalizedphysical function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Montreal Cognitive Assessment (MoCA)

    4 weeks

  • Barthel Index

    4 weeks

  • Isometric Handgrip Strength (IHS)

    4 weeks

  • Immobility Syndrome Scale

    4 weeks

Study Arms (2)

Simple-Task (multicomponent physical exercise)

ACTIVE COMPARATOR

Single-task (ST) training group developed an exercise program based on Functional Exercise Circuit (FEC) protocol

Other: Single-Task

Dual-Task training (multicomponent physical exercise + cognitive tasks)

EXPERIMENTAL

Dual-task (DT) training group performed motor (FEC) plus cognitive tasks

Other: Dual-Task

Interventions

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.

Simple-Task (multicomponent physical exercise)

DT training (multicomponent physical exercise + cognitive tasks)

Dual-Task training (multicomponent physical exercise + cognitive tasks)

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Institutionalized older people between 65 and 75
  • mild to moderate cognitive impairment

You may not qualify if:

  • Acute or chronic pathologies that prevent exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de las Americas

Santiago, Santiago Metropolitan, 7750495, Chile

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Although blinding is not possible for participants in exercise-intervention research, the outcome assessors and data analysts were masked to group assignments. The study was unblinded after the statistical analyses were completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 12, 2024

Study Start

November 8, 2023

Primary Completion

March 5, 2024

Study Completion

April 5, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations