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Clinical Trials/NCT07556198
NCT07556198
Completed
Not Applicable

Effects of Whole-Body Vibration Combined With Foot Core Exercise Training on Muscle Strength, Balance, and Proprioception in Overweight and Obese Young Adults: A Randomized Controlled Single-Blind Trial

Istinye University1 site in 1 country26 target enrollmentStarted: February 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Limits of Stability (composite score, %)

Overview

Brief Summary

This randomized, single-blind clinical trial investigates whether adding whole-body vibration (WBV) to a supervised foot core exercise program improves ankle muscle strength, balance, and proprioception in overweight and obese young adults (BMI 25.0-39.9 kg/m²). Participants attended 24 face-to-face sessions over 8 weeks (3×/week) under physiotherapist supervision. Outcomes included isometric inversion/eversion strength (hand-held dynamometry) and instrumented balance/proprioception tests (Limits of Stability, mCTSIB, single-leg balance, single-leg proprioception) recorded by a computerized balance analysis system.

Detailed Description

Design: randomized controlled, single-blind, parallel-group trial conducted at İstinye University Physiotherapy and Rehabilitation Practice & Research Center. Eligible adults (18-35 years; BMI 25-39.9 kg/m²) able to stand barefoot ≥15 s single-leg and perform 5 repetitions of 60° knee-flexion squats without rest were enrolled. Stratified randomization (sex, BMI) with computer sequence (Research Randomizer) and sealed opaque envelopes allocated participants to: (1) Exercise Group (EG): progressive foot core exercises performed on a vibration platform with vibration OFF; (2) WBV-Combined Exercise Group (TEG): identical exercises WITH synchronous whole-body vibration (20-50 Hz; 15-60 s bouts) using a DKN Technology Xg-10 Pro device. Both groups completed 24 supervised sessions across 8 weeks (3×/week). A standardized warm-up/self-massage of the foot/ankle preceded exercises; progression targeted repetitions, active time, and (in TEG) vibration frequency.

Assessments were performed pre- and post-intervention in fixed order with rest intervals. Ankle inversion/eversion strength was measured using a J-Tech Commander Echo digital handheld dynamometer (kg-force). Balance and proprioception were quantified on the PROKIN computerized system (Limits of Stability; mCTSIB; single-leg balance; single-leg proprioception metrics including trunk total standard deviation and mean tracking error).

Statistical plan: normality by Shapiro-Wilk; parametric tests for normally distributed variables (paired t-test within groups; independent t-test between groups), Mann-Whitney U for non-normal age, chi-square for categorical variables; Cohen's d for effect size where within-group change was significant. Analyses in IBM SPSS 25.0. Sample size was estimated a priori for large effect (d=0.8), α=0.05, power=0.80 (planned n=26; 13/group). Post-hoc power for Limits of Stability change in TEG yielded d=0.96, power=0.87. No funding; no conflicts declared.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Single (Participant). Masking was applied to participants; groups were scheduled to avoid contact.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • • Age 18-35 years; BMI 25.0-39.9 kg/m².
  • Ability to stand barefoot on a firm surface ≥15 seconds single-leg (one attempt).
  • Ability to perform 5 repetitions of 60° knee-flexion squat without needing rest.
  • Turkish language proficiency for written and verbal communication.

Exclusion Criteria

  • Any medical history requiring regular physician follow-up.
  • Musculoskeletal trauma within the past 12 months.
  • Use within 48 h of medications affecting musculoskeletal performance.
  • Prior surgery or residual deficits from previous trauma.
  • Pregnancy or suspected pregnancy.
  • Any reported contraindication to use of a vibration platform.
  • During study: pain \>3/10 on VAS; abnormal blood pressure responses during/after sessions; three consecutive absences; failure to meet progression criteria; incident illness/trauma; withdrawal request.

Arms & Interventions

Exercise Group (EG)

Active Comparator

Progressive foot core exercise program performed on a vibration platform with vibration disabled; supervised 3×/week for 8 weeks (24 sessions). Standardized warm-up/self-massage, then sequence including foot tapping, bilateral heel raises, arch raises with toe ab/adduction, and single-leg stance on BOSU; progression by repetitions and active time.

Intervention: Supervised Foot Core Exercise Training (No Vibration) (Behavioral)

Exercise Group (EG)

Active Comparator

Progressive foot core exercise program performed on a vibration platform with vibration disabled; supervised 3×/week for 8 weeks (24 sessions). Standardized warm-up/self-massage, then sequence including foot tapping, bilateral heel raises, arch raises with toe ab/adduction, and single-leg stance on BOSU; progression by repetitions and active time.

Intervention: Whole-Body Vibration via DKN Technology Xg-10 Pro (Device)

WBV-Combined Exercise Group (TEG)

Experimental

Identical supervised foot core exercise program performed with whole-body vibration during exercises; same schedule (3×/week, 8 weeks).

Intervention: Whole-Body Vibration via DKN Technology Xg-10 Pro (Device)

Outcomes

Primary Outcomes

Limits of Stability (composite score, %)

Time Frame: Baseline to Week 8

Composite score from PROKIN computerized balance analysis system; higher scores reflect better voluntary control within stability boundaries; device-generated percentage scale. Safety Issue: No.

Secondary Outcomes

  • Single-Leg Balance test (device score)(Baseline to Week 8)
  • Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)(Baseline to Week 8)
  • Ankle Strength (kg-force)(Baseline to Week 8)
  • Single-Leg Proprioception(Baseline to Week 8)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mirsad Alkan

asst. prof.

Istinye University

Study Sites (1)

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