NCT06383910

Brief Summary

This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group. In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period. The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

October 12, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

February 15, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

geriatriccognitive functionssquare stepping exercisequality of life

Outcome Measures

Primary Outcomes (4)

  • Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks

    The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    Baseline and 6 weeks

  • Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks

    The Stroop test measures the interference between reading and naming the ink color of words, highlighting the conflict between automatic and controlled cognitive processes.

    Baseline and 6 weeks

  • Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks

    The Trail Making Test is a test that involves visual scanning and working memory. Test consists of two parts, A and B. In Part A (TMT-A), the participant must draw a line to connect consecutive numbers, from 1 to 25. In Part B (TMT-B), the participant connects numbers and letters in an alternating progressive sequence, 1 to A, A to 2, 2 to B, and so on

    Baseline and 6 weeks

  • Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks

    The WHOQOL-OLD is an instrument for the assessment of subjective quality of life in elderly people.

    Baseline and 6 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The group which doesn't get any intervention.

Exercise Group

ACTIVE COMPARATOR

The group received square stepping exercise training three times a week for six weeks.

Behavioral: Square Stepping Exercise

Interventions

The exercise is performed on a thin exercise mat divided into 40 small squares. Participants are shown specific step patterns on this mat and are instructed to repeat the same step pattern until the end of the exercise mat. Once a pattern is completed on the exercise mat, its mirror-image pattern is also performed. The basic pattern is repeated 3-5 times, followed by the same number of repetitions for the mirror-image pattern. However, if participants struggle with the pattern, it is repeated until they learn it. Individuals execute the demonstrated pattern on the exercise mat and return to the beginning of the mat after completing it.

Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Individuals aged between 65-75 years old,
  • Able to walk independently,
  • Hodkinson Mental Test score ≥ 8,
  • Without any neurological or lower extremity-affecting diseases,
  • Healthy geriatric individuals who agreed to participate in the study were included.

You may not qualify if:

  • Using 3 or more medications,
  • Hodkinson Mental Test score \<8,
  • Currently participating in any exercise/rehabilitation program,
  • Geriatric individuals with a history of lower extremity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Study Officials

  • Yelda Soykurt

    PhD student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 15, 2024

First Posted

April 25, 2024

Study Start

October 12, 2021

Primary Completion

December 27, 2023

Study Completion

January 5, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations