- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07920653
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics (PCE-DM2)
Impact of Pilates Versus Core Stabilization Exercises on Balance Deficits and Functional Mobility in Elderly Patients With Type 2 Diabetes
This randomized controlled trial aims to evaluate and compare the effects of a 6-week Pilates-based rehabilitation program versus core stabilization exercises on balance deficits, postural sway, and functional mobility in elderly patients with type 2 diabetes. The study seeks to determine which intervention is more effective in improving neuromuscular control, stability, and overall functional independence in this geriatric diabetic population.
Study Overview
Status
Intervention / Treatment
Detailed Description
Type 2 diabetes mellitus in elderly individuals is frequently associated with peripheral neuropathy, reduced muscle strength, and balance impairment, leading to an increased risk of falls. Both Pilates and core stabilization exercises are non-pharmacological interventions used to enhance core stability, proprioception, and functional performance.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heba Mohamed Ali, Ass. Prof.
- Phone Number: +20 10 06327885
- Email: Hebamohamed@pt.bsu.edu.eg
Study Contact Backup
- Name: Aya Ali Amer, Principal Investigator
- Phone Number: 01021744210
- Email: aya.ali2011996@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Old age patients of both genders (age 65 tob75) diagnosed with Type 2 Diabetes Mellitus.Ability to walk independently with or without assistive devices.
- Presence of mild to moderate balance deficits confirmed by clinical assessment.
Exclusion Criteria:Any history of severe neurological disorders (e.g., stroke, Parkinson's disease).
- Uncontrolled cardiovascular conditions or severe orthopedic injuries affecting lower limbs.Visual or vestibular impairments that significantly affect balance.
Cognitive impairment or inability to follow instructions (Mini-Mental State Examination score below normal thresholds
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A -Pilates Training Exercise
Participants in this group will undergo a structured Pilates exercise program |
supervised Pilates session lasting for 45 minutes, performed 3 times per week for 8 weeks. It includes mat Pilates exercises focusing on alignment, breathing, and core control) |
|
Active Comparator: Group B:Core Stabilization Group
Participants in this group will undergo a structured core stability training program |
supervised Pilates session lasting for 45 minutes, performed 3 times per week for 8 weeks. It includes mat Pilates exercises focusing on alignment, breathing, and core control) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Balance ABalance and Gait Speedssessment (Berg Balance Scale _Minimum Value): 0 (Maximum Value): 56 (Unit/Direction
Time Frame: Baseline (Week 0) and Post-Intervention (Week 6)
|
The Berg Balance Scale (BBS) will be used to assess dynamic and static balance deficits in elderly participants. |
Baseline (Week 0) and Post-Intervention (Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Mobility (Timed Up and Go Test)
Time Frame: Baseline (Week 0) and Post-Intervention (Week 6)
|
Functional Mobility (Timed Up and Go Test) |
Baseline (Week 0) and Post-Intervention (Week 6)
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPTBSUREC/0115114726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared to maintain patient privacy and confidentiality as per institutional guidelines.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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