NCT06375785

Brief Summary

The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 16, 2024

Last Update Submit

April 22, 2024

Conditions

Keywords

elderly peopleLSVT-BIGOtagoexercisebalance

Outcome Measures

Primary Outcomes (5)

  • Timed Up &Go Test

    This test is an assessment tool used to predict fall risk in the elderly. It is a test that measures the time between the individual getting up from the chair, walking 3 meters, and turning and sitting again. If the time taken is more than 35 seconds, it is interpreted as an increased risk of falling, while if it is less than 15 seconds, it is interpreted as a decreased risk of falling (Browne et al. 2018).

    At baseline and at week 12

  • Performanz Balance System

    It is an electronic monitoring device designed to analyze lower extremity muscle groups that affect human balance. The basic method used is to reveal the contraction behavior of the muscles by following the balance focus. The device measured the differences between dynamic and static balance, eyes open and eyes closed balance, double leg and single leg (right/left) balance, and right/left foot balance in elderly individuals. During the test, the participant was asked to stand on the balance system and maintain his balance by following the commands given. The platform is linked to computer software that allows the balance to be evaluated objectively. Thanks to this software, measurements were monitored from the researcher's tablet or laptop (Performans Arge ve Yazılım Hizmetleri A.Ş. 2020).

    At baseline and at week 12

  • Functional Reaching Test

    It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. It is a test that can be completed in 5 minutes and evaluates how far the person can reach forward while in a fixed position and their stability during this time, accompanied by an observer. The participant is asked to stand in a stable upright position against a wall (not touching it). The arm is extended against the wall at 90 degrees and the location of the 3rd metacarpal bone is recorded. The participant is asked to lie forward as much as possible without taking a step, and the location of the 3rd metacarpal bone is recorded. The difference between the initial and final localizations of the 3rd metacarpal bone is measured. 3 trials are made and the average of the last two is taken. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al. 1992).

    At baseline and at week 12

  • Six Minute Walking Test

    It is a test used to evaluate an individual's aerobic capacity. Individuals are asked to walk as much as possible for 6 minutes in a corridor that is at least 30 meters long and has a flat and hard surface. The distance traveled in 6 minutes is recorded. While the average walking distance is 570 meters for men aged 50-70 and 540 meters for women; It is stated as 530 meters for men aged 70-80 and 470 meters for women. Test results lower than these values may be associated with a decrease in aerobic capacity (American Thoracic Society 2002).

    At baseline and at week 12

  • Tinetti Balance and Gait Assessment

    This functional test, which is used to determine the risk of falling in the elderly, contains 13 items for balance and 9 items for walking. In the balance test, each item is scored as 0, 1, 2. In the walking test, each item is scored as 0 or 1. A separate score can be calculated for balance and walking, as well as a total score. It is thought that those with scores of 26 and below have problems in terms of balance and walking functions, and it has been stated in studies that those with scores of 19 and below have a fivefold increased risk of falling compared to normal people (Tinetti 1986; Çifçili et al. 2004; Onat et al. 2014).

    At baseline and at week 12

Secondary Outcomes (5)

  • Activity-Specific Balance and Confidence Scale

    At baseline and at week 12

  • Five Times Sit to Stand

    At baseline and at week 12

  • Montreal Cognitive Assessment Test

    At baseline and at week 12

  • KATZ Activities of Daily Living Scale

    At baseline and at week 12

  • Clinical Frailty Scale

    At baseline and at week 12

Study Arms (2)

Group 1 - Otago-based (slow rhythmic) exercise group

EXPERIMENTAL
Other: Otago-based (slow rhythmic) exercise group

Group 2 - LSVT BIG-based (large amplitude) exercise group

EXPERIMENTAL
Other: LSVT BIG-based (large amplitude) exercise group

Interventions

Slow Rhythmic Exercises (Otago based) A.Strength training 1. Knee flexion and extension 2. Ankle dorsiflexion and plantar flexion 3. Toes flexion and extension 4. Hip abduction and adduction B. Balance training 1\. Stepping backwards, walking and turning 2.Side walking 3. Octet walking 4.Tandem walking 5. Standing up from a sitting position

Group 1 - Otago-based (slow rhythmic) exercise group

Large Amplitude Exercises (based on LSVT-BIG) 1. Bending towards the floor and rising towards the ceiling (opening) while sitting 2. While sitting, turn to the right and left with the body and reach out 3. Sit down 4. Step forward 5. Sidestepping 6. Stepping back 7. Step forward and extend arm towards the ceiling 8. Step sideways and extend arm towards the ceiling 9. Walking with big steps 10. Turning from right to left and left to right while walking

Group 2 - LSVT BIG-based (large amplitude) exercise group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older
  • living in a nursing home
  • Knowing how to read and write Turkish
  • Cognitive functions are sufficient for communication (Standardized Mini Mental Test score over 21 points)
  • Being between 1-5 on the Clinical Fragility Scale
  • Not taking medical medications regularly due to pain
  • Volunteering to participate in the study

You may not qualify if:

  • Having vision and hearing problems that affect communication (except for individuals who communicate with glasses and hearing aids)
  • Having a disease that causes neurological, orthopedic and musculoskeletal problems
  • Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases
  • anemic individuals
  • Having severe cerebrovascular and peripheral venous insufficiency
  • Having had an operation in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Eyüpsultan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

March 1, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations