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

21. August 2026 aktualisiert von: Samera El Bakkali, Universiteit Antwerpen

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Samera El Bakkali, Master's degree
Telefonnummer: 0032485203666
E-Mail: samera.elbakkali@uantwerpen.be

Studieren Sie die Kontaktsicherung

Name: Dirk Vissers, Professor
Telefonnummer: 0032474595599
E-Mail: dirk.vissers@uantwerpen.be

Studienorte

Belgien
- Antwerpen
  - Edegem, Antwerpen, Belgien, 2650
    - Rekrutierung
    - Universiteit Antwerpen
    - Kontakt:
      
      Samera El Bakkali, Master
      
      Telefonnummer: 0032485203666
      
      E-Mail: samera.elbakkali@uantwerpen.be
    - Kontakt:
      
      Dirk Vissers, Professor ( PhD)
      
      Telefonnummer: 0032474595599
      
      E-Mail: dirk.vissers@uantwerpen.be
    - Hauptermittler:
      
      Samera El Bakkali, Master

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
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	Verhalten: 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. Andere Namen: Gleichgewichtstraining Bewegungstraining Balance control exercises
Aktiver Komparator: 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.	Verhalten: 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. Andere Namen: Bewegungstraining Relaxation exercises

Teilnehmergruppe / Arm

Intervention / Behandlung

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

Verhalten: 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.

Andere Namen:

Gleichgewichtstraining
Bewegungstraining
Balance control exercises

Aktiver Komparator: 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.

Verhalten: 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.

Andere Namen:

Bewegungstraining
Relaxation exercises

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Static balance control Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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 Zeitfenster: At baseline and after 12 weeks intervention	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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Self-Reported Physical activity: frequency Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At week 1, week 12 of intervention and week 16 (follow-up)	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 Zeitfenster: At baseline and after 12 weeks of intervention	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 Zeitfenster: At baseline and after 12 weeks of intervention	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 Zeitfenster: At baseline and after 12 weeks of intervention	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

Andere Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Body Mass Index Zeitfenster: At baseline and after 12 weeks of intervention	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 Zeitfenster: At baseline and after 12 weeks of intervention	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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universiteit Antwerpen

Mitarbeiter

University Hospital, Antwerp

Ermittler

Studienleiter: Eveline Dirinck, Professor, University Hospital of Antwerp (UZA) / University of Antwerp
Studienstuhl: Dirk Vissers, Professor, Universiteit Antwerpen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. November 2025

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. August 2027

Studienanmeldedaten

Zuerst eingereicht

18. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. August 2026

Zuerst gepostet (Tatsächlich)

25. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

EDGE number: 4197

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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