Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2

Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2: a Randomized Controlled Trial

This study focuses on improving balance control and somatosensory functions in individuals aged 60 years and older with diabetes mellitus tyoe 2 (DMT2). Older adults with DMT2 are at an increased risk of balance problems due to diabetic complications such as neuropathy, retinopathy, and possibly reduced vestibular function. The aim of the study is to investigate whether a 12-week exercise program, with or without additional balance exercises, can improve balance control, enhance somatosensory functions (such as touch and vibration thresholds), and positively impact diabetes-related parameters, including HbA1c levels.

The study is designed as a randomized controlled trial (RCT). Participants are selected based on reduced balance control identified in a prior cross-sectional study. The intervention group follows an exercise program in accordance with international guidelines, supplemented with balance exercises supervised by the researcher (physiotherapist). The control group follows the same guidelines but without balance exercises; instead, they perform relaxation exercises. Balance control is assessed both statically and dynamically, while somatosensory functions are measured, and diabetes-related parameters are collected.

The intervention is primarily home-based, supported by an activity tracker, but the balance or relaxation exercises are conducted under supervision at a designated location. This study aims to contribute to the quality of life of older adults with DMT2 by reducing balance problems and fall risks.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2; Somatosensory Disorders; Impaired Balance in Elderly; Balance Control in Elderly
• Intervention / Treatment: Behavioral: Balance control and exercise training; Behavioral: Relaxation and exercise training

Detailed Description

Diabetes mellitus type 2 (DMT2) is the most common form of diabetes, typically occurring after the age of 40. Insulin resistance, reduced insulin secretion, or a combination of both underlie the disease, resulting in elevated blood sugar levels (hyperglycemia). The development of DMT2 is attributed to a lifestyle characterized by reduced physical activity, sedentary behavior, and poor dietary habits, leading to an increased body fat percentage, particularly through the accumulation of visceral adipose tissue. Prolonged fatty acid concentrations and hormonal imbalances result in oxidative stress, which disrupts the environment responsible for the body's sensitivity to insulin. Consequently, insulin resistance develops, and over time, reduced insulin secretion occurs due to the exhaustion of pancreatic β-cells. Risk factors for DMT2 include being overweight, obesity, metabolic disturbances (dyslipidemia, high blood pressure, hyperglycemia), and smoking. It is estimated that 8% of the Belgian population is affected by DMT2, a percentage expected to increase in the future (1). Individuals with DMT2 may develop diabetic complications if blood sugar levels (especially hyperglycemia) remain uncontrolled. At the time of diagnosis, 30% of patients already experience complications (2). After more than 10 years of diagnosis, the risk of damage to large and/or small blood vessels (angiopathy) increases. Common complications include damage to small vessels in the eyes (retinopathy) and diabetic neuropathy, which can impair tactile sensation (perception of touch/pressure) and vibratory sense (perception of vibrations) (3-5).

Physical activity has long been recognized as a key intervention for improving various diabetes-related characteristics in individuals with DMT2, such as insulin sensitivity and glucose control. Studies have shown that both aerobic (endurance) training and strength training contribute to better blood sugar regulation and overall health. These forms of physical activity not only improve muscle mass but also enhance cardiovascular health and endurance, benefiting the overall physical fitness of individuals with DMT2.

Although these general exercise interventions are effective, it remains unclear whether they are sufficient to address specific balance issues in this population. As balance control depends on a complex integration of somatosensory input, muscle strength, and coordination, the question arises whether adding targeted balance exercises to an exercise program is necessary to improve balance control.

This study investigates whether a standard exercise program consisting of aerobic training and strength training, in line with international guidelines, is sufficient to improve balance control in older adults with DMT2, or whether specific balance exercises are necessary. The distinction between the intervention and control groups allows for the evaluation of the relative impact of balance exercises. These findings could contribute to a more targeted and efficient approach to addressing balance problems in this population.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samera El Bakkali, Master's degree; Phone Number: 0032485203666; Email: samera.elbakkali@uantwerpen.be
• Study Contact Backup: Name: Dirk Vissers, Professor; Phone Number: 0032474595599; Email: dirk.vissers@uantwerpen.be

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Universiteit Antwerpen
      • Contact: Samera El Bakkali, Master; Phone Number: 0032485203666; Email: samera.elbakkali@uantwerpen.be
      • Contact: Dirk Vissers, Professor ( PhD); Phone Number: 0032474595599; Email: dirk.vissers@uantwerpen.be
      • Principal Investigator: Samera El Bakkali, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus
• Age 60 years or older
• Both men and women
• Impaired balance control identified during the testing procedure for balance control, defined as a score of less than 30 seconds on the Standing on Foam with Eyes Closed test and/or less than 10 seconds on the Single Leg Stance with Eyes Open test
• Able to understand the Dutch language.

Exclusion Criteria:

• A history of central neurological disease including stroke, multiple sclerosis, Parkinson's disease, dementia or intracranial tumor
• Severe visual impairment such as blindness, cataract or glaucoma
• Physical impairment which would preclude subjects from participating in an exercise /physical activity program (e.g. orthopedic conditions, severe cardiac conditions, uncontrolled hypertension etc.)
• Need of physical or material support
• HbA1c < 7.5% (- the aim is to include patients with an HbA1c of <7.5%, but if the treating endocrinologist considers an HbA1c value of 7.5 - 8% desirable for medical reasons, this patient will still be included)
• Use of medication that can affect balance (e.g. sedatives, antidepressants, or antipsychotics)
• Not understanding the Dutch language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance training arm; The intervention arm runs for 12 weeks and follows ADA/EASD guidance. Participants complete ≥150 minutes per week of aerobic activity on at least three days, choosing their preferred modality and setting (e.g., walking, treadmill, cycling, swimming, rowing, elliptical, arm ergometer; home, outdoors, gym, or group). Sedentary time should be minimized, and strength training is advised twice weekly with progressive loading. The distinctive component is balance training: 9 supervised sessions of 30 minutes delivered by a research physiotherapist or via home visit if travel is not feasible. Each session includes a warm-up, targeted static and dynamic balance work performed with and without simple equipment such as a foam pillow, and a cooldown with upper- and lower-body stretching. Exercises are progressed and individualized to challenge stability while maintaining safety and feasibility for older adults, with consistent therapis	Behavioral: Balance control and exercise training; Physical activity has long been recognized as a key intervention for improving various diabetes-related characteristics in individuals with DMT2. Although general exercise interventions are effective, it remains unclear whether they are sufficient to address specific balance issues in this population. As balance control depends on a complex integration of somatosensory input, muscle strength, and coordination, the question arises whether adding targeted balance exercises to an exercise program is necessary to improve balance control. This study investigates whether a standard exercise program consisting of aerobic training and strength training, in line with international guidelines, is sufficient to improve balance control in older adults with DMT2, or whether specific balance exercises are necessary. The distinction between the intervention and control groups allows for the evaluation of the relative impact of balance exercises.; Other Names: Balance training; Exercise training; Balance control exercises
Active Comparator: Control arm; Similar to the intervention group, participants in this group will follow recommended physical activity guidelines. Participants can also choose the preferred aerobic and strength physical activity, but excluding yoga, Thai chi or other balance involving exercises. Moreover, this group will not receive any balance exercises as part of their exercise program. To have an equal one-on-one time with the researcher physical therapist, participants will receive relaxation exercises for 30 minutes per week for a total of 9 sessions.	Behavioral: Relaxation and exercise training; Relaxation techniques will be used upon the home prescribed exercise program in the control arm, in order to have an equal one-on-one time with the researcher physical therapist.; Other Names: Exercise training; Relaxation exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static balance control	Standing balance is measured with four modified Romberg conditions of increasing difficulty, each performed with eyes open and eyes closed. Each position is held as long as possible up to 30 seconds. Timing starts once a steady stance is achieved and stops at loss of position or at 30 seconds. Three trials are permitted per condition and the best trial counts. Scores from all eight conditions are summed to a total score ranging from 0 to 240 seconds.	At baseline and after 12 weeks intervention
Timed Up and Go	Dynamic balance is assessed with the Timed Up and Go test using a standardized protocol, in which participants rise from a chair, walk three metres, turn, return and sit down. The time needed to complete the test is recorded in seconds. The test is performed in three trials and the best performance is retained.	At baseline and after 12 weeks intervention
Tandem Gait	Dynamic balance is assessed with a tandem gait test in which participants attempt 20 consecutive heel to toe steps along a straight tape line. The test ends at 20 steps or at violation of the test guidelines. The score is the number of correctly performed steps, ranging from 0 to 20, and is obtained in three trials with the best performance retained.	At baseline and after 12 weeks intervention
Mini Balance Evaluation Systems Test	Balance control is assessed with the Mini Balance Evaluation Systems Test, a 14 item performance based test covering anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Each item is scored from 0 to 2, giving a total score ranging from 0 to 28, with higher scores indicating better balance control.	At baseline and after 12 weeks intervention
Touch pressure threshold	Touch pressure thresholds are assessed with Semmes Weinstein monofilaments using the 4-2-1 stepping algorithm. A set of 20 logarithmically ordered filaments is applied and at each step the same filament delivers five stimuli. Testing covers six foot sites across plantar and dorsal regions and the threshold is reported per site as the filament scale value.	At baseline and after 12 weeks intervention
Vibration threshold: neurothesiometer	Vibration thresholds are assessed with a Howell neurothesiometer. Vibration at 56 Hz is delivered while the voltage increases from 0 to 50 volts and the participant signals when vibration is first perceived. That voltage is recorded as the vibration detection threshold, with lower values indicating better vibration sense.	At baseline and after 12 weeks intervention
Vibration threshold: tuning fork	Vibration sense is assessed with a 128 Hz Rydel Seiffer tuning fork. The fork is struck maximally and placed on standardized reference points until the vibration fades, and the participant signals when it is no longer felt. The result is read from the 0 to 8 scale of the fork, with higher scores indicating better vibration sense.	At baseline and after 12 weeks intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Physical activity: frequency	Habitual physical activity is assessed with the International Physical Activity Questionnaire Short Form, a self reported questionnaire covering the preceding seven days. Participants report the number of days on which vigorous activity, moderate activity and walking were performed, counting only bouts of at least ten minutes. The frequency is reported separately for each of the three domains and expressed in days per week, with a possible range of 0 to 7 days.	At week 1, week 12 of intervention and week 16 (follow-up)
Self-reported physical activity: duration	Habitual physical activity is assessed with the International Physical Activity Questionnaire Short Form, a self reported questionnaire covering the preceding seven days. Participants report the usual duration of vigorous activity, moderate activity and walking on the days these were performed, counting only bouts of at least ten minutes. Durations reported in hours and minutes are converted to minutes and multiplied by the number of days per week, giving the total weekly duration for each of the three domains, expressed in minutes per week and reported separately per domain.	At week 1, week 12 of intervention and week 16 (follow-up)
Self-reported physical activity: sedentary time	Sedentary behaviour is assessed with the International Physical Activity Questionnaire Short Form as the time spent sitting on a typical weekday during the preceding seven days, including sitting at work, at home, while studying and during leisure time, and excluding time spent sleeping. Participants report this in hours and minutes, which are converted into a single value expressed in minutes per day.	At week 1, week 12 of intervention and week 16 (follow-up)
Daily energy expenditure	Objective physical activity is monitored with the Garmin Vivosmart 5 worn on the wrist continuously throughout the monitoring period and removed only for charging. The device estimates total daily energy expenditure from accelerometry and heart rate data, combining resting and activity related expenditure. Values are averaged across all valid recording days, defined as days with sufficient wear time, to arrive at a single value expressed in kilocalories per day.	At week 1, week 12 of intervention and week 16 (follow-up)
Heart rate	The same wrist worn activity tracker records heart rate continuously by optical sensor throughout the monitoring period. Recorded values are averaged across all valid recording days, defined as days with sufficient wear time, to arrive at a single value expressed in beats per minute.	At week 1, week 12 of intervention and week 16 (follow-up)
Step count	The Garmin vivosmart 5 activity tracker registers daily step counts that are averaged across all valid recording days, defined as days with sufficient wear time, to arrive at a single value expressed in steps per day	At week 1, week 12 of intervention and week 16 (follow-up)
Functioning confidence	Activities-Specific Balance Confidence Scale (ABC scale) describes 16 activities that the participant has to score from 0 to 100%, meaning having no confidence in not losing balance when performing the activity to having maximal confidence. A total score of 1600 can be obtained and will be calculated to a score of 100%, in which a score <50% indicates low levels of functioning, 50-80% indicates a moderate level of functioning and a score of >80% means the subject has a high level of functioning.	At baseline and after 12 weeks of intervention
Anxiety	Symptoms of anxiety are assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale, a self reported questionnaire covering the preceding week and excluding physical symptoms. The subscale consists of 7 items, each scored from 0 to 3, giving a total score ranging from 0 to 21. Higher scores indicate more symptoms of anxiety.	At baseline and after 12 weeks of intervention
Depression	Symptoms of depression are assessed with the depression subscale of the Hospital Anxiety and Depression Scale, a self reported questionnaire covering the preceding week and excluding physical symptoms. The subscale consists of 7 items, each scored from 0 to 3, giving a total score ranging from 0 to 21. Higher scores indicate more symptoms of depression.	At baseline and after 12 weeks of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Body weight is measured with a digital scale to the nearest 0.1 kilogram and body height is measured with the participant standing against a wall. Both measurements are combined to calculate body mass index as weight divided by height squared, expressed in kilograms per square metre (kg/m^2).	At baseline and after 12 weeks of intervention
Glycated haemoglobin	Glycated haemoglobin is obtained by blood sampling or retrieved from the electronic health record, and reflects average blood glucose concentration over the preceding two to three month, expressed in %.	At baseline and after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: University Hospital, Antwerp
• Investigators: Study Director: Eveline Dirinck, Professor, University Hospital of Antwerp (UZA) / University of Antwerp; Study Chair: Dirk Vissers, Professor, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: exercise; balance training; movement; Improvement of balance control in elderly with diabetes mellitus type 2 through exercise
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Somatosensory Disorders; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: EDGE number: 4197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No