NCT06390813

Brief Summary

The study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. The volunteer individuals participating in the study were randomly divided into 3 groups as otago exercise group, square stepping exercise group and control group with equal number of men and women. The individuals who participated in study had a homogeneous distribution in terms of age, gender, BMI, height, weight and occupational status in all three groups. However, the number of female individuals was higher in all three groups. In the study, individuals in the exercise training groups received square stepping and otago exercise training 3 days a week for 6 weeks, while individuals in the control group did not receive any training. All three groups were evaluated before and six weeks after the training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

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

January 11, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

December 29, 2023

Last Update Submit

April 25, 2024

Conditions

Keywords

Square Stepping ExerciseOtago ExercisesElderlyFear of FallBalance Disorders

Outcome Measures

Primary Outcomes (1)

  • Tinetti's International Fall Efficacy Scale

    Asseses perception of balance and stability during activities of daily living. Assesses fear of falling in the elderly population. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling? Score: 1 = very confident 10 = not confident at all A total score of greater than 70 indicates that the person has a fear of falling.

    6 weeks

Study Arms (2)

Square Stepping Exercise

EXPERIMENTAL

It is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Individuals are basically required to step in the direction of the length without stepping on the lines forming the squares. Before the CAE training, there will be a 5 minutes warm-up and then a minute cool down period. A total of 18 stepping patterns are planned to be used (6 beginner, 6 intermediate, 6 advanced). Basically, a pattern will be repeated 3-5 times and then the mirror image pattern will be repeated the same number of times. However, if the participant has difficulty in practicing the pattern, it will be repeated until he/she learns it, and after practicing the pattern 3 times without any errors, the next pattern will be used.

Behavioral: Square Stepping Exercise Training

Otago Exercise Training

EXPERIMENTAL

The exercises were performed 3 days a week for 6 weeks and 18 sessions of 60 minutes in total, including warm-up and cool-down periods of 5 minutes each session. It consists of a total of 22 exercises, including 5 warm-up movements, 5 strengthening exercises and 12 balance exercises.

Behavioral: Otago Exercise Training

Interventions

A total of 18 sessions of Otago Training were conducted 3 days a week for 6 weeks, each session lasting 60 minutes in total, including 5 minutes of warm-up and cool-down periods.

Otago Exercise Training

A total of 18 sessions of SSE were performed 3 days a week for 6 weeks, each session lasting 40 minutes.

Square Stepping Exercise

Eligibility Criteria

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

You may qualify if:

  • years old
  • Education level at least literate
  • Able to walk independently
  • Standardized Mini Mental Test Score ≥ 24
  • No neurological or lower extremity disease
  • Healthy geriatric individuals who agreed to participate in the study

You may not qualify if:

  • Taking 3 or more medications that may affect cognitive status
  • Individuals continuing any exercise/rehabilitation program
  • Underwent any surgery for the lower extremities
  • Having any neurological-orthopedic problem that may affect gait and balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

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

December 29, 2023

First Posted

April 30, 2024

Study Start

January 11, 2022

Primary Completion

October 30, 2023

Study Completion

November 18, 2023

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations