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

NCT07786194 | Recruiting

• 1 other identifier: EDGE number: 4197
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2; Impaired Balance in Elderly; Somatosensory Disorders; Balance Control in Elderly

Keywords

Improvement of balance control in elderly with diabetes mellitus type 2 through exercise; balance training; exercise; movement

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

• Self-Reported Physical activity: frequency

  At week 1, week 12 of intervention and week 16 (follow-up)

• Self-reported physical activity: duration

  At week 1, week 12 of intervention and week 16 (follow-up)

• Self-reported physical activity: sedentary time

  At week 1, week 12 of intervention and week 16 (follow-up)

• Daily energy expenditure

  At week 1, week 12 of intervention and week 16 (follow-up)

• Heart rate

  At week 1, week 12 of intervention and week 16 (follow-up)

Other Outcomes (2)

• Body Mass Index

  At baseline and after 12 weeks of intervention

• Glycated haemoglobin

  At baseline and after 12 weeks of intervention

Study Arms (2)

Balance training arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

Balance control and exercise training BEHAVIORAL

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.

Also known as: Exercise training, Balance control exercises, Balance training

Balance training arm

Relaxation and exercise training BEHAVIORAL

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.

Also known as: Relaxation exercises, Exercise training

Control arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: collaborator
• Universiteit Antwerpen: lead

Study Sites (1)

Universiteit Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Somatosensory Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eveline Dirinck, Professor

  University Hospital of Antwerp (UZA) / University of Antwerp

  STUDY DIRECTOR

• Dirk Vissers, Professor

  Universiteit Antwerpen

  STUDY CHAIR

Central Study Contacts

Samera El Bakkali, Master's degree

CONTACT

0032485203666; samera.elbakkali@uantwerpen.be

Dirk Vissers, Professor

CONTACT

0032474595599; dirk.vissers@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: A 12-week intervention for older adults with DMT2 will be carried out. Both arms receive standard ADA/EASD care and activity guidance. Home-based program will be given via Physitrack.be and an activity tracker (Garmin) (or booklet). Prescription: ≥150 min/week moderate-to-vigorous aerobic activity on ≥3 days with no \>2 consecutive days off; 2-3 strength sessions/week; interrupt sitting every 30 min. Strength: ≥50% 1RM with progression. Participants choose modalities. Intervention arm: plus 9 × 30-min supervised balance sessions by a physiotherapist at the university or via home visit; includes warm-up, static/dynamic balance, and cooldown. Control arm: same guidance, but no balance-focused activities (e.g., relaxation exercises); receives 9 × 30-min relaxation sessions to match contact time. Supervision/adherence: indirect monitoring via tracker for 7 days at weeks 0, 12 and week 16 (follow-up); IPAQ-SF at the same times; 9 therapist contacts plus pre/post testing.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 25, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)