The Instant Effect of Whole Body Vibration in Diabetics

NCT06878651 | Not Yet Recruiting

• 1 other identifier: 2024-553
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Overview of Diabetes and Its Complications:

• Diabetes is a chronic health issue that can lead to various complications, affecting human health negatively. One of these complications is diabetic peripheral neuropathy (DPN), which results from hyperglycemia and affects peripheral nerves. This can lead to sensory loss, motor dysfunction, and ultimately, disability.
• The complications from diabetes can result in the loss of function and disability, affecting various systems, including the nervous system (e.g., retinopathy, neuropathy, and atherosclerosis). Peripheral Neuropathy in Diabetes:
• DPN occurs due to damage to peripheral nerves caused by hyperglycemia. Over time, it affects the small unmyelinated fibers responsible for pain and temperature sensations, leading to axonal degeneration and demyelination, causing sensory loss.
• In later stages, motor dysfunction can also occur, impacting intrinsic foot muscles, leading to muscle weakness and atrophy. Whole Body Vibration (WBV) Therapy:
• WBV is a therapeutic method that uses mechanical vibrations from a vibrating platform to stimulate muscle contractions. It is being researched for its effects on managing diabetic neuropathy and related complications.
• Studies have shown that WBV can improve balance, functional independence, and postural stability in patients with diabetes, potentially serving as an alternative or complement to traditional balance exercises.
• A randomized controlled trial compared the effects of WBV and Tai Chi on postural balance and found that WBV was more effective in promoting functional independence and balance. Impact on Sensory Function and Balance:
• As DPN progresses, sensory loss may prevent patients from noticing injuries, which could lead to severe complications. A study conducted in 2017 showed that WBV improved vibration perception thresholds (VPT) in patients with type 2 diabetes and peripheral neuropathy, indicating improved sensory function, which is crucial for maintaining balance and walking.
• This improvement is thought to be linked to increased blood circulation in peripheral tissues and improved glucose levels due to WBV therapy. Dual Task Performance and WBV: \- Dual-task performance, which involves performing cognitive and motor tasks simultaneously, is typically impaired in patients with diabetic neuropathy, leading to difficulties in daily activities. WBV has shown potential in improving muscle strength and balance, which could enhance patients' ability to perform dual tasks more effectively. Research Findings:
• Several studies have demonstrated that WBV training can significantly improve both static and dynamic balance in patients with diabetic neuropathy. Given that balance issues are common in these patients and contribute to a higher risk of falls, these improvements are particularly important.
• The literature emphasizes the need for continued research to clarify the physiological mechanisms behind WBV's effects on sensory feedback mechanisms, which are essential for postural control. Need for Further Research:
• Despite promising findings, some studies have pointed out the need for more research to validate the clinical efficacy of WBV for managing chronic complications like neuropathic pain and improving quality of life in diabetic patients.
• There is a need for better-designed studies to confirm the long-term benefits of WBV training in diabetic patients and to develop standardized protocols for its use. Proposed Study:
• A planned study aims to investigate the immediate effects of WBV on balance, dual-task performance, and walking in individuals with type 2 diabetes and peripheral neuropathy. The study will include 40 patients who meet specific inclusion criteria, with participants randomized into two groups (WBV training group and control group).
• Data will be collected on participants' balance performance (using the Timed Up and Go test), dual-task performance (using a dual-task cost formula), and walking features (using the 1-minute walk test). The results will be analyzed using SPSS software. Methodology: \- The study will use random assignment and include a control group to evaluate the immediate effects of WBV. Data collection will include assessments of balance, dual-task performance, and walking capabilities before and after WBV treatment.

Conditions

Diabetus Mellitus; Diabetic Foot Ulcer; Diabetic Neuropathic Ulcer

Keywords

Diabetic Foot; Diabetes Mellitus; Foot Ulceration; Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• Balance Performance

  Change in balance performance assessed using the Timed Up and Go (TUG) test. The test measures the time taken (in seconds) to rise from a chair, walk 3 meters, turn, and return to sit. Lower times indicate better balance and functional mobility.

  For the control group the test will be administered once at baseline and 10 minute later on the same day . In the vibration training group, it will be administered at Baseline (Before WBV) and Immediately After WBV (within 5 minutes).

• Gait Performance

  Change in walking capacity measured by the 1-Minute Walk Test. Total distance walked (in meters) is recorded, with greater distances indicating better walking endurance and gait function.

  For the control group (one-time assessment at baseline and 10 minutes later), For the WBV Training Group Baseline (Pre-WBV) and Immediately Post-WBV

Secondary Outcomes (3)

• Functional Mobility (Timed Up and Go Test - TUG)

  Start (Before WBV) and Immediately After WBV (within 10 minutes)

• Cognitive-Motor Performance (Dual-Task Timed Up and Go Test - DT-TUG)

  Start (Before WBV) and Immediately After WBV (within 5 minutes)

• Walking Capacity (1-Minute Walk Test)

  Start (Before WBV) and Immediately After WBV (within 5 minutes)

Other Outcomes (2)

• Patient Demographics and Clinical Characteristics

  In the study group, the whole body vibration device will be applied by vibrating under the floor at baseline and after 10 minutes in the same day.

• Dual-Task Performance

  For the control group the test will be administered baseline and 15 minutes later in the same day. In the vibration training group, it will be administered at Baseline (Before WBV) and Immediately After WBV (within 5 minutes).

Study Arms (2)

Control Group

NO INTERVENTION

In the Control Group, balance assessment with the Timed Up and Go Test, evaluation of dual task performance with the Dual Task Cost Gap Formula, and gait assessment with the 1 Minute Walk Test will be performed.

Whole Body Vibration Training Group

EXPERIMENTAL

For the Whole Body Vibration Training Group, balance, dual task performance and gait will be evaluated. These participants will be evaluated before and after 10 minutes of vibration application.

Device: The Whole Body Vibration

Interventions

The Whole Body Vibration DEVICE

Whole Body Vibration device may positively affect balance, dual-tasking and gait parameters by increasing the sensory input received under the sole in individuals diagnosed with diabetic foot. In individuals diagnosed with diabetic foot, the sensory/vibration perception threshold of individuals decreases due to the disease, so the balance of individuals is impaired. This may cause these individuals to experience gait disturbances in daily life. There are almost no studies in the literature on the use of whole body vibration for this patient group. This study will discuss the applicability of whole body vibration in the clinic for individuals diagnosed with diabetic foot and that it can be an additional adjunct to treatment.

Whole Body Vibration Training Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients aged 40-75 years,
• Having a score of 13-29 on the Michigan Questionnaire (intermediate level),
• Having a Mini Mental Test score of 24 and above,
• Having an HbA1C \<8.5%, having controlled blood glucose levels in the last three months,
• Being able to walk independently
• Volunteering to participate in the study.

You may not qualify if:

• Those with diabetic infected wounds,
• Those with neurological diseases other than diabetic neuropathy,
• Those with rheumatoid arthritis, vestibular system disorders, visual
• Impairments, those with a history of trauma, injury and surgery,
• Those with knee or hip replacement,
• Those with a history of epilepsy and cognitive problems.

Sponsors & Collaborators

• Hacettepe University: lead
• Gulhane Training and Research Hospital: collaborator
• Gulhane School of Medicine: collaborator

Study Sites (1)

Gülhane Eğitim ve Araştırma Hastanesi

Ankara, Ankara, 06300, Turkey (Türkiye)

Location

Related Publications (2)

• Sohrabzadeh E, Kalantari KK, Naimi SS, Daryabor A, Akbari NJ. The immediate effect of a single whole-body vibration session on balance, skin sensation, and pain in patients with type 2 diabetic neuropathy. J Diabetes Metab Disord. 2021 Nov 25;21(1):43-49. doi: 10.1007/s40200-021-00933-w. eCollection 2022 Jun.

  PMID: 35673453 BACKGROUND

• Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.

  PMID: 32550157 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Tezel Şahan

  Gülhane Sağlık Bilimleri Üniversitesi

  STUDY DIRECTOR

• Dilek N Kara

  Bağlı Olmayan

  PRINCIPAL INVESTIGATOR

• Kerim B Profesör Doktor

  Gulhane Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Tezel Şahan

CONTACT

+90; tezelyildirim.sahan@sbu.edu.tr

Dilek N Kara

CONTACT

+90; pt.dileknurkara@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study, no formal masking (blinding) is applied, as the nature of the intervention (whole-body vibration) makes it challenging to conceal from participants and assessors. However, alternative approaches to minimizing bias are considered. Masking in the Study Participants: Not masked. Since WBV is a physical intervention, participants are aware they are receiving treatment, making blinding impossible. Researchers Conducting the Intervention: Not masked. The investigators administering WBV are aware of the intervention settings and participant exposure. Outcome Assessors (If Different from Researchers): Not masked. The same researchers conducting the intervention may also conduct pre- and post-tests, increasing the potential for observer bias. Data Analysts: Potential for masking. If feasible, data analysis could be conducted by an independent researcher blinded to the intervention phase (pre- or post-WBV) to reduce bias in interpreting results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study follows an interventional pre-post experimental design, focusing on the immediate effects of whole-body vibration (WBV) on balance, gait, and dual-task performance in patients with diabetic foot. The interventional model used is a single-group pretest-posttest design, where participants undergo a single WBV session, and their performance metrics are assessed before and after the intervention.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 17, 2025
• Study Start: April 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)