Diabetes Mellitus Type 2NCT07786194
Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2
A study testing Relaxation and exercise training in people with Diabetes Mellitus Type 2 and Impaired Balance in Elderly, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Impaired Balance in Elderly, Somatosensory Disorders
- What is being tested?
- Relaxation and exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universiteit Antwerpen
Edegem, Antwerpen, 2650
Samera El Bakkali, Master, 0032485203666, samera.elbakkali@uantwerpen.be
Dirk Vissers, Professor ( PhD), 0032474595599, dirk.vissers@uantwerpen.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2, Impaired Balance in Elderly, Somatosensory Disorders, Balance Control in Elderly
- Being tested
- Balance control and exercise training, Relaxation and exercise training
- Keywords
- Improvement of balance control in elderly with diabetes mellitus type 2 through exercise, balance training, exercise, movement
- Medical subject headings
- Diabetes Mellitus, Type 2, Somatosensory Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance control and exercise trainingBehavioural
Also called Exercise training, Balance control exercises, Balance 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.
Relaxation and exercise trainingBehavioural
Also called Relaxation exercises, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Relaxation and exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 12 weeks intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start13 Nov 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Samera El Bakkali, Universiteit Antwerpen
- Investigators
- Eveline Dirinck, Professor, Study director, University Hospital of Antwerp (UZA) / University of AntwerpDirk Vissers, Professor, Study chair, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786194
- Sponsor's protocol ID
- EDGE number: 4197
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07786194
- Acronym / sponsor ID
- EDGE number: 4197
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balance training arm | Experimental | Behavioral: Balance control and exercise trainingThe 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 |
| Control arm | Active comparator | Behavioral: Relaxation and exercise trainingSimilar 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance control and exercise trainingAlso: Exercise training, Balance control exercises, Balance trainingPhysical 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. | Behavioural | Balance training arm |
| Relaxation and exercise trainingAlso: Relaxation exercises, Exercise trainingRelaxation 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. | Behavioural | Control arm |
Primary outcome
Static balance control
Time frame: 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.
Timed Up and Go
Time frame: 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.
Tandem Gait
Time frame: 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.
Mini Balance Evaluation Systems Test
Time frame: 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.
Touch pressure threshold
Time frame: 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.
Vibration threshold: neurothesiometer
Time frame: 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.
Vibration threshold: tuning fork
Time frame: 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.
9 secondary outcomes
Self-Reported Physical activity: frequency
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Self-reported physical activity: duration
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Self-reported physical activity: sedentary time
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Daily energy expenditure
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Heart rate
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Step count
Time frame: At week 1, week 12 of intervention and week 16 (follow-up)
Functioning confidence
Time frame: At baseline and after 12 weeks of intervention
Anxiety
Time frame: At baseline and after 12 weeks of intervention
Depression
Time frame: At baseline and after 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eveline Dirinck, Professor study director
University Hospital of Antwerp (UZA) / University of Antwerp
Dirk Vissers, Professor study chair
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and exercise training in people with Diabetes Mellitus Type 2 and Impaired Balance in Elderly, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samera El Bakkali, Master's degree (0032485203666, samera.elbakkali@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance control (time frame: At baseline and after 12 weeks intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.