NCT06713551

Brief Summary

The subject of this research is to investigate the effect of high amplitude calisthenic group exercises with music on balance and dual task performance in elderly individuals. The aim of this study is to examine the effect of music during high amplitude calisthenic group exercises on dual task performance and balance in elderly residents living under the administration of Kagıthane Municipality in Istanbul.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

November 27, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

November 27, 2024

Last Update Submit

May 9, 2025

Conditions

Keywords

exercisehigh amplitudemusic therapyolder adults

Outcome Measures

Primary Outcomes (4)

  • Mini-Best Test

    The main focus of the Mini-BEST TEST is to emphasize dynamic balance. The scale is used to assess balance and the risk of falling. It allows for the dynamic assessment of balance. It consists of 14 task items representing four balance control systems: prospective posture adjustments, compensatory postural adjustments, sensory orientation, and walking stability. Some tasks involve sitting; these are standing, standing on tiptoe, single-leg standing, compensatory reactions forward, backward, and sideways, tasks to be performed with eyes closed on a sloping surface with foam surface and walking. Speed changes, dizziness, walking over obstacles, and timing are included. Each item is scored on a three-point scale (0-2), with a total maximum score of 28 points. Better balance performance is indicated by higher scores. 2 points indicate the highest functional level, while 0 indicates the lowest functional level. If a person needs physical assistance to perform, one function gets 0 points.

    10 minutes

  • Dual Task Questionnaire

    Dual task (DT) is a simultaneous neurophysiological experimental procedure that requires an individual to perform two tasks. DT is also mutual communication between motor and cognitive. When two tasks are performed simultaneously, attention capacity should be used effectively, and attention should be divided according to difficulty and priority. Problems will arise when the difficulty level increases or attention capacity decreases. Evaluation of individuals' DT performance is carried out by clinical tests and laboratory measurements. During these tests, additional tasks such as motor (pressing a button, moving something...) or cognitive (counting, answering simple questions...) tasks are given to the person. Changes in strategies during DT are also examined with varying visual and sensory perception. It will be used to learn dual task performance in the study

    7 minutes

  • Timed Up and Go Test

    The Timed Up and Go Test is performed by giving verbal instructions to the patient to get up from the chair as quickly and safely as possible, walk 3 meters following the marked line on the floor, turn, walk back again, and sit down. Below 10 seconds; the patient walks independently, the risk of falling is very low. 11-19 seconds; the patient walks independently, there is a low to moderate risk of falling. 20-29 seconds; occasional assistance may be needed, there is a moderate to high risk of falling. Over 30 seconds occasionally, assistance is needed and the risk of falling is high

    5 minutes

  • Geriatric Depression Scale

    The Geriatric Depression Scale consists of 30 self-reported questions that elderly individuals can easily mark with yes or no responses. Questions 3, 4, 5, 6, 8, 10, 11, 12, 13, 14, 16, 17, 18, 20, 22, 23, 24, 25, 26, and 28 contain reverse statements. In scoring the scale, 1 point is given for each response indicating depression, and 0 points for other responses, which is considered as the total depression score. The scoring of the scale is as follows: 0-10 points "no depression", 11-13 points "possible depression", 14 and above points "definite depression". The scale scores range from a minimum of 1 to a maximum of 30. The evaluation of the Geriatric Depression Scale is as follows: for questions 1, 2, 7, 9, 15, 19, 21, 27, 29, and 30, 1 point is given for each "no" response and 0 points for "yes" response, for questions 3, 4, 5, 6, 8, 10, 11, 12, 13, 14, 16, 17, 18, 20, 22, 23, 24, 25, 26, and 28, 1 point is given for each "yes" response and 0 points for "no" response

    7 minutes

Secondary Outcomes (2)

  • Physical Activity Scale for the Elderly (PASE)

    10 minutes

  • Mini Mental State Examination

    10 minutes

Study Arms (2)

Big amplitude calisthenic group exercises with music

EXPERIMENTAL

The exercise program will consist of balance and mobility-oriented exercises such as reaching forward and upward while sitting on a chair, taking steps forward, backward, sideways and backward while standing, transferring weight, counting in place, sit-to-stand exercises, walking, changing directions or walking over obstacles (Appendix: Exercise Program). This exercise program will be applied to the first group with the accompaniment of classical Western music, while the other group will be applied without music. The exercise programs will be performed for both groups for 40 minutes, two days a week and for eight weeks.

Other: Big Amplitude Calisthenic Group Exercise with Music

Big amplitude calisthenic group exercises

ACTIVE COMPARATOR

The exercise program will consist of balance and mobility-oriented exercises such as reaching forward and upward while sitting on a chair, taking steps forward, backward, sideways and backward while standing, transferring weight, counting in place, sit-to-stand exercises, walking, changing directions or walking over obstacles (Appendix: Exercise Program). This exercise program will be applied to the first group with the accompaniment of classical Western music, while the other group will be applied without music. The exercise programs will be performed for both groups for 40 minutes, two days a week and for eight weeks.

Other: Big Amplitude Calisthenic Group Exercise

Interventions

The exercise program will consist of balance and mobility-oriented exercises such as reaching forward and upward while sitting on a chair, taking steps forward, backward, sideways and backward while standing, transferring weight, counting in place, sit-to-stand exercises, walking, changing directions or walking over obstacles (Appendix: Exercise Program). This exercise program will be applied to the first group with the accompaniment of classical Western music, while the other group will be applied without music. The exercise programs will be performed for both groups for 40 minutes, two days a week and for eight weeks.

Big amplitude calisthenic group exercises with music

The exercise program will consist of balance and mobility-oriented exercises such as reaching forward and upward while sitting on a chair, taking steps forward, backward, sideways and backward while standing, transferring weight, counting in place, sit-to-stand exercises, walking, changing directions or walking over obstacles (Appendix: Exercise Program). This exercise program will be applied to the first group with the accompaniment of classical Western music, while the other group will be applied without music. The exercise programs will be performed for both groups for 40 minutes, two days a week and for eight weeks.

Big amplitude calisthenic group exercises

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • To receive at least 21 points from the Mini Mental Test Evaluation
  • To reside in the region affiliated with the Kağıthane Municipality
  • To be independent in daily living activities
  • To have access to the Kağıthane Municipality Elderly Day Service Center

You may not qualify if:

  • Having vision and hearing problems
  • Neurological, orthopedic problems
  • Accompanying cardiovascular problems
  • Using a walking aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.

    PMID: 12661673BACKGROUND
  • Silsupadol P, Siu KC, Shumway-Cook A, Woollacott MH. Training of balance under single- and dual-task conditions in older adults with balance impairment. Phys Ther. 2006 Feb;86(2):269-81.

    PMID: 16445340BACKGROUND
  • de Witte M, Spruit A, van Hooren S, Moonen X, Stams GJ. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. Health Psychol Rev. 2020 Jun;14(2):294-324. doi: 10.1080/17437199.2019.1627897. Epub 2019 Jul 15.

    PMID: 31167611BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guzin Kaya Aytutuldu

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

November 27, 2024

Primary Completion

January 27, 2025

Study Completion

February 28, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations