- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495280
Effects of Dynamic Neuromuscular Stabilization Exercises Versus Balance Exercises in Older Adults
Effects of Dynamic Neuromuscular Stabilization Exercises Versus Balance Exercises on Functional Outcomes, Balance, and Quality of Life in Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Aging leads to a decline in postural control, muscle strength, balance, and functional capacity, increasing the risk of falls and negatively impacting quality of life. Therefore, investigating the effectiveness of exercise approaches targeting neuromuscular control and stability in older adults is of great importance.
Dynamic Neuromuscular Stabilization (DNS) is a developmental kinesiology-based approach that aims to reactivate the deep stabilizer system, promote diaphragmatic breathing, and restore optimal movement patterns. Traditional balance exercises are commonly used in older adults to improve balance performance. However, evidence regarding the effects of DNS exercises on functional capacity, balance, and quality of life in older adults is limited.
The aim of this randomized controlled clinical trial is to compare the effects of Dynamic Neuromuscular Stabilization exercises and traditional balance exercises on functional capacity, balance, and quality of life in older adults. Individuals aged 65 and over will be included in the study and randomized into two groups: a DNS exercise group and a balance exercise group.
Functional capacity and physical performance assessments will be conducted using the Hand Grip Strength Test, Short Physical Performance Battery (SPPB), and Timed Up and Walk Test. Trunk stability and deep stabilizer system activation will be assessed using the Stabilizer Pressure Biofeedback (SPB) device. Physical activity level will be measured using the Physical Activity Assessment Scale for the Elderly, and quality of life will be measured using the SF-12 Quality of Life Scale. All assessments will be conducted before the intervention and after the exercise program.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Develi, PhD C
- Phone Number: 0905555936293
- Email: elifstn@yahoo.com
Study Locations
-
-
Ataşehir
-
Istanbul, Ataşehir, Turkey (Türkiye), 34758
- Yeditepe University
-
Contact:
- Elif Develi, PhD C
- Phone Number: 0905555936293
- Email: elifstn@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 65 and over, of both sexes
- Ability to walk independently and perform basic daily living activities without assistance
- Willingness to participate and written consent
Exclusion Criteria:
- Severe neurological disorders or advanced cognitive impairment
- Serious cardiopulmonary or systemic diseases that would prevent participation in exercise
- History of orthopedic surgery or acute trauma within the last 6 months
- Psychiatric disorders or communication difficulties that would prevent participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dynamic Neuromuscular Stabilization (DNS) Exercise Group
Participants assigned to this group will receive Dynamic Neuromuscular Stabilization (DNS) exercises focusing on trunk stabilization, diaphragmatic breathing, and activation of the deep stabilizing system.
|
Participants in this group will receive Dynamic Neuromuscular Stabilization (DNS) exercises based on developmental kinesiology principles.
The intervention focuses on activation and coordination of the deep stabilizing system, diaphragmatic breathing, regulation of intra-abdominal pressure, and restoration of optimal postural and movement patterns.
Exercises will be performed in progressively challenging positions appropriate for older adults and will be supervised by a physiotherapist throughout the intervention period.
|
|
Active Comparator: Balance Exercise Group
Participants assigned to this group will receive conventional balance exercises aimed at improving postural control and functional balance.
|
Conventional static and dynamic balance exercises commonly used in geriatric rehabilitation, including weight-shifting and functional balance tasks, supervised by a physiotherapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: 6 weeks
|
The Short Physical Performance Battery (SPPB) will be used to assess functional capacity, including balance, gait speed, and lower extremity strength in older adults. Higher scores indicate better physical performance. In elderly individuals, a total SPPB score of 8 points or less is considered a clinically significant threshold for poor physical performance and frailty. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
|
Timed Up and Go Test (TUG)
Time Frame: 6 weeks
|
The Timed Up and Go Test will be used to evaluate dynamic balance and functional mobility. Shorter completion times indicate better balance and mobility performance. In the elderly population, a TUG test duration of 13.5 seconds or more is used as a cut-off value indicating an increased risk of falls. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
|
Stabilizer Pressure Biofeedback (SPB)
Time Frame: 6 weeks
|
Stabilizer Pressure Biofeedback will be used to assess activation and control of the deep stabilizing system during specific stabilization tasks. In elderly individuals, maintaining a pressure change of 0-2 mmHg compared to an initial pressure of 40 mmHg during the abdominal drawing-in maneuver, as assessed by Stabilizer Pressure Biofeedback, is considered the optimal value for proper activation of the deep abdominal muscles. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Grip Strength Test
Time Frame: 6 weeks
|
Hand grip strength will be assessed using a hand dynamometer to evaluate upper extremity muscle strength as an indicator of overall muscle function. In elderly individuals, a hand grip strength below 16 kg in women and 27 kg in men is considered an indicator of low muscle strength and possible sarcopenia. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
|
Physical Activity Scale for the Elderly (PASE)
Time Frame: 6 weeks
|
The Physical Activity Scale for the Elderly (PASE) will be used to assess habitual physical activity levels in older adults. A PASE score of 67 or below is considered indicative of low physical activity levels and physical inactivity in elderly individuals. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
|
Short Form-12 Health Survey (SF-12)
Time Frame: 6 weeks
|
Health-related quality of life will be evaluated using the Short Form-12 (SF-12) questionnaire, including physical and mental component summary scores. In older individuals, SF-12 component scores below 50 indicate that health-related quality of life is below societal norms. Assessments will be conducted as an initial assessment before the six-week exercise program and as a final assessment after the program is completed. |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irmak Sıla Çetinel, Yeditepe University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IrmakCetinel
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Older Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
University of West AtticaCompletedHealthy Older Adults | Community Dwelling Older Adults | Older Adults (65 Years and Older)Greece
-
Aix Marseille UniversitéNot yet recruitingHealthy Young Adults | Healthy Older AdultsFrance
-
Hasselt UniversityNot yet recruitingHealthy | Elderly | Young Adults | Older Adults (65 Years and Older)Belgium
-
Universidade Católica PortuguesaClínica NeuroVida (Portugal)Not yet recruitingHealthy Older AdultsPortugal
-
Pamukkale UniversityCompleted
-
Luleå Tekniska UniversitetCompletedHealthy Older AdultsSweden
-
Sahmyook UniversityCompletedHealthy Older AdultsSouth Korea
-
Instituto Politécnico de LeiriaCompleted
-
Hungarian University of Sports ScienceSemmelweis UniversityActive, not recruiting
Clinical Trials on Dynamic Neuromuscular Stabilization Exercises
-
Esra BECENINot yet recruiting
-
Riphah International UniversityNot yet recruitingDiabetes Mellitus Type 2Pakistan
-
Istanbul University - Cerrahpasa (IUC)Bezmialem Vakif UniversityNot yet recruitingLymphedema, Lower LimbTurkey
-
University of Health Sciences LahoreCompletedNon-specific Low Back Pain (NSLBP)Pakistan
-
Tokyo Metropolitan UniversityNot yet recruiting
-
Esra BECENINot yet recruitingForward Head PostureTurkey (Türkiye)
-
Cairo UniversitySTDFCompleted
-
Safiye EsinCompletedLow Back Pain | Low Back Pain, Mechanical, Biofeedback, Pain, ChronicTurkey (Türkiye)
-
Dow University of Health SciencesCompleted
-
Lahore University of Biological and Applied SciencesNot yet recruitingSacroiliac Joint DysfunctionPakistan