NCT06876922

Brief Summary

Aging leads to a gradual decline in muscle function and structural changes in the musculoskeletal system, which can affect balance and increase the risk of falls. This study aimed to assess the effects of thoracic mobility exercises on balance, exercise capacity, sleep quality, pain, and daily activities in 28 geriatric individuals (65+ years). Participants were divided into two groups: the Thoracic mobility exercises group performed conventional exercises with additional thoracic mobility exercises, while the Conventional physiotherapy exercises group did not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 3, 2025

Last Update Submit

March 17, 2025

Conditions

Keywords

BalanceExercise CapacityGeriatricsThoracic MobilitySleep Quality

Outcome Measures

Primary Outcomes (2)

  • Beck Balance Scale

    Beck Balance Scale is a scale that evaluates balance in the elderly, where some performance tests are applied to evaluate the deterioration in balance function. It is a valid tool used in clinical practice and research for the evaluation of the effectiveness of interventions and quantitative definitions of function. It consists of 14 items that are scored by observing performance. A ruler, stopwatch, step, chair and 15-20 minutes are required for the application. The highest score is 56. 0-20 indicates balance disorder, 21-40 indicates acceptable balance, and 41-56 indicates good balance.

    baseline- 6 weeks later

  • Time Up-Go test

    To perform the Time Up-Go test, the patient rises from a chair, walks at a comfortable and safe pace to a line on the floor three meters away, turns, and sits back in the chair. The test is attempted once to become familiar with the test. If the patient uses a walking aid, they can perform the test with it. A shorter time indicates better functional performance. A test score of ≥13.5 seconds indicates those at high risk of falling in the community setting. However, threshold values reported in the literature range from 10 to 33 seconds

    baseline- 6 weeks later

Secondary Outcomes (4)

  • Evaluation of Exercise Capacity

    baseline- 6 weeks later

  • Evaluation of Sleep Quality

    baseline- 6 weeks later

  • The Geriatric Pain Scale

    baseline- 6 weeks later

  • The Bartel daily life activity assessment scale

    baseline- 6 weeks later

Study Arms (2)

the Thoracic mobility exercises group

EXPERIMENTAL

Thoracic mobility exercises Group: Conventional physiotherapy exercises were given to individuals participating in the Thoracic mobility exercises group. Conventional physiotherapy exercises included warm-up, stretching, strengthening, posture and breathing exercises integrated between them. These exercises were performed in 30-40 minute sessions, 3 days a week and for 6 weeks. Thoracic mobility exercises were applied to individuals participating in the study group in addition to conventional physical therapy exercises.

Other: Thoracic mobility exercises Group

the Conventional physiotherapy exercises group

ACTIVE COMPARATOR

Conventional physiotherapy exercises Group: Conventional physiotherapy exercises were given to individuals participating in the Conventional physiotherapy exercises group. Conventional physiotherapy exercises included warm-up, stretching, strengthening, posture and breathing exercises integrated between them. These exercises were performed in 30-40 minute sessions, 3 days a week and for 6 weeks. Use this module to add descriptions of each arm in the study and to list the interventions being studied.

Other: the Conventional physiotherapy exercises Group

Interventions

Thoracic mobility exercises Group: Conventional physiotherapy exercises were given to individuals participating in the control group. Conventional physiotherapy exercises included warm-up, stretching, strengthening, posture and breathing exercises integrated between them. These exercises were performed in 30-40 minute sessions, 3 days a week and for 6 weeks. Thoracic mobility exercises were applied to individuals participating in the study group in addition to conventional physical therapy exercises.

the Thoracic mobility exercises group

the Conventional physiotherapy exercises Group: Conventional physiotherapy exercises were given to individuals participating in the Conventional physiotherapy exercises group. Conventional physiotherapy exercises included warm-up, stretching, strengthening, posture and breathing exercises integrated between them. These exercises were performed in 30-40 minute sessions, 3 days a week and for 6 weeks. Use this module to add descriptions of each arm in the study and to list the interventions being studied.

the Conventional physiotherapy exercises group

Eligibility Criteria

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

You may qualify if:

  • Elderly individuals over the age of 65
  • Those who scored at least 24 points on the mini mental test
  • Those who did not need care in their daily living activities

You may not qualify if:

  • Those with uncontrolled Diabetes Mellitus and Hypertension
  • Those with severe obesity
  • Those who use medications that may increase the risk of falling
  • Those with serious auditory and visual problems
  • Those with physical and psychological problems affecting physical mobility
  • Those who have undergone surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran Univercity

Kırşehir, Central, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 28 geriatric individuals aged 65 and over who do not need care were included in our study and were divided into 2 groups as thoracic mobility exercises and Conventional physiotherapy exercises by randomization. The Conventional physiotherapy exercises; While the thoracic mobility exercises group was made to do conventional exercises including warm-up, stretching, strengthening, posture and breathing exercises, in addition to these exercises, thoracic mobility exercises were done. The individuals included in the study were studied for a total of 8 weeks, 1 week for baseline, 1 week for 6 weeks later and 6 weeks for exercise training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 14, 2025

Study Start

January 10, 2024

Primary Completion

March 1, 2024

Study Completion

June 12, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations