Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI

NCT04463797 | Completed

• 1 other identifier: YM109044F
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blinded, randomized controlled trail with pre- and post-measurements. The inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score \< 26, and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: unstable physical condition, any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study. Twenty-eight elderly will be recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group (n=14) or control group (n=14). The intervention for both group will be 50 minutes per session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score. Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive function, physical performance, and brain activation.

Conditions

Frailty; Mild Cognitive Impairment

Keywords

Frailty; Mild cognitive impairment; Square-stepping exercise; Cognitive function

Outcome Measures

Primary Outcomes (2)

• Fried frailty criteria

  To assess the frailty status, score ranges from 1 to 5.

  10 minutes

• The Montreal Cognitive Assessment

  Evaluating global cognitive function, score ranges from 1 to 30.

  8 minutes

Secondary Outcomes (8)

• Frailty reverse rate

  2 minutes

• MCI reverse rate

  2 minutes

• Digit Span Test

  8 minutes

• Trail Making Test

  8 minutes

• Timed Up and Go Test

  5 minutes

Study Arms (2)

Square-stepping exercise group

EXPERIMENTAL

Square-stepping exercise

Other: Square-stepping exercise

Control group

ACTIVE COMPARATOR

Whole-body stretching and upper extremity strengthening

Other: Stretching and strengthening

Interventions

Square-stepping exercise OTHER

The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.

Square-stepping exercise group

Stretching and strengthening OTHER

whole-body stretching and upper extremity strengthening

Control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 65 to 90 years old
• Presence of at least one of the 5 physical characteristics of frailty defined by Fried
• Mini-mental state examination (MMSE) score more than or equal to 24
• Montreal cognitive assessment (MoCA) score less than 26
• Ability to walk independently for 1 min without assistive devices

You may not qualify if:

• Unstable physical condition
• Any neurological or psychiatric disorder
• Diagnosed with learning disability which may affect participation in this study

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, Beitou District, 112, Taiwan

Location

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: August 15, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 29, 2025

Record last verified: 2022-09

Locations

TW (1)