NCT07618143

Brief Summary

The primary aim of this study is to investigate the effects of easily applicable somatic-based chair exercises on balance and pain in the elderly. Additionally, the study aims to reveal the impact of exercise on functionality and cognitive level, and the resulting changes in quality of life. The main research questions addressed in this study are:

  • What are the most suitable exercise models that can be applied to improve pain control and balance in the elderly?
  • How do the results of different approaches aimed at improving the quality of life in the elderly differ?

Trial Health

65
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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
15mo left

Started Jun 2026

Status
not yet recruiting

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

May 5, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

June 25, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 5, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

elderlysomatic exercisesbalancequality of lifechair exercises

Outcome Measures

Primary Outcomes (3)

  • Pain Assessment

    Pain will be assessed via the Brief Pain Inventory (BPI). BPI measures two objectives: the subjective severity of pain and the causal effect of pain. The questions include numerical rating scales from 0 to 10 (0: none; 1-4: mild; 5-6: moderate, and 7-10: severe).

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Balance Ability Assessment

    Balance ability will be assessed by using the Berg Balance Test (BBT). The BBT measures balance ability (static and dynamic) among older adults. It is a qualitative measure that assesses balance by performing functional activities such as reaching, bending, transferring, and standing, including most components of postural control. The test contains 14 items. A higher score indicates better balance and a lower risk of falling.

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Objective Balance Assessment via Becure Balance System

    Objective balance performance will be assessed using the Becure Balance System. The system utilizes the Nintendo WiiFit balance board integrated with computer-based software to evaluate static standing balance, center of gravity distribution, and postural oscillations. The validity and reliability of the system have previously been established.

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

Secondary Outcomes (7)

  • Cognitive Assessment

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Quality of Life Assessment

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Assessment of Mobility

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Upper Extremity Muscle Strength Assessment

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • Upper Extremity Flexibility Assessment

    1 week before the study (T0); at week 4 (T1) and at week 8 (T2)

  • +2 more secondary outcomes

Other Outcomes (1)

  • The Mini-Mental State Examination (MMSE)

    1 week before the study (T0)

Study Arms (2)

Somatic-based Chair Exercise Group

EXPERIMENTAL

This group will participate in a structured somatic-based chair exercise program. The program will last for 8 weeks, with sessions held twice a week, each lasting 35 to 40 minutes.

Other: Somatic-Based Chair Exercises

Conventional Exercise Group

ACTIVE COMPARATOR

The conventional exercise group will participate in a program that combines static stretching and range of motion (ROM) exercises. The exercise program will last for 8 weeks, with sessions held twice a week, each lasting 35 to 40 minutes.

Other: Conventional Exercise Group

Interventions

The intervention includes a structured somatic-based chair exercise program (SSCE) developed in accordance with Thomas Hanna's somatic education approach. The program consists of gentle, slow, and controlled movements incorporating pandiculation techniques to improve body awareness and movement control. Exercises target multiple body regions, including the neck, trunk, pelvis, shoulders, upper and lower extremities, wrists, hips, and ankles. Sessions will be performed twice weekly for 8 weeks, with each session lasting approximately 35-40 minutes. A total of 35 volunteers will be enrolled in the SSCE.

Also known as: Structured Somatic-Based Chair Exercises, SSCE
Somatic-based Chair Exercise Group

A total of 35 volunteers will be enrolled in the conventional exercise program, which combines range of motion (ROM) exercises and passive stretching of the same body regions and muscle groups as those addressed in the somatic exercise group.

Conventional Exercise Group

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • To be volunteered to participate
  • To be able to speak and understand Turkish at a good level

You may not qualify if:

  • Scoring \<24 on the Mini-Mental State Examination
  • Any neurological or orthopedic problem that would prevent the implementation of assessment and exercise methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Pınar Kaya Sarıbaş, Assoc. Prof.

    Medipol University

    STUDY DIRECTOR
  • İlkay Tuğçe Köse, M.Sc.

    Istanbul Gedik University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İlkay Tuğçe Köse, M.Sc.

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 5, 2026

First Posted

June 1, 2026

Study Start (Estimated)

June 25, 2026

Primary Completion (Estimated)

June 25, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05