Balance Control in Elderly, Diabetes Mellitus Type 2, Impaired Balance in Elderly, Somatosensory Disorders
Conditions
Keywords
Improvement of balance control in elderly with diabetes mellitus type 2 through exercise, balance training, exercise, movement
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.
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.
Interventions
BEHAVIORALBalance 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.
BEHAVIORALRelaxation 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.
Sponsors
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static balance control | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Physical activity: frequency | 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. |
| Self-reported physical activity: duration | 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. |
| Self-reported physical activity: sedentary time | 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. |
| Daily energy expenditure | 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. |
| Heart rate | 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. |
| Step count | 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 |
| Functioning confidence | 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. |
| Anxiety | 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. |
| Depression | 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. |
Countries
Belgium
Contacts
CONTACTSamera El Bakkali, Master's degree
CONTACTDirk Vissers, Professor
STUDY_DIRECTOREveline Dirinck, Professor
University Hospital of Antwerp (UZA) / University of Antwerp
STUDY_CHAIRDirk Vissers, Professor
Universiteit Antwerpen
Outcome results
None listed