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

Browse trials for

• Diabetes Mellitus, Type 2 10,371
• Somatosensory Disorders 65
• Motor Activity 9,798

Keywords

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

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 48 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.

Study arms

• Experimental
  Balance training arm

  The intervention arm runs for 12 weeks and follows ADA/EASD guidance. Participants complete ≥150 minutes per week of aerobic activity on at least three days, choosing their preferred modality and setting (e.g., walking, treadmill, cycling, swimming, rowing, elliptical, arm ergometer; home, outdoors, gym, or group). Sedentary time should be minimized, and strength training is advised twice weekly with progressive loading. The distinctive component is balance training: 9 supervised sessions of 30 minutes delivered by a research physiotherapist or via home visit if travel is not feasible. Each session includes a warm-up, targeted static and dynamic balance work performed with and without simple equipment such as a foam pillow, and a cooldown with upper- and lower-body stretching. Exercises are progressed and individualized to challenge stability while maintaining safety and feasibility for older adults, with consistent therapis

  Behavioral: Balance control and exercise training

• Active comparator
  Control arm

  Similar to the intervention group, participants in this group will follow recommended physical activity guidelines. Participants can also choose the preferred aerobic and strength physical activity, but excluding yoga, Thai chi or other balance involving exercises. Moreover, this group will not receive any balance exercises as part of their exercise program. To have an equal one-on-one time with the researcher physical therapist, participants will receive relaxation exercises for 30 minutes per week for a total of 9 sessions.

  Behavioral: Relaxation and exercise training

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.

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

• 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.

  Also known as: Relaxation exercises, Exercise training

Primary outcomes

1. 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.

   Time frame: At baseline and after 12 weeks intervention

2. 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.

   Time frame: At baseline and after 12 weeks intervention

3. 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.

   Time frame: At baseline and after 12 weeks intervention

4. 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.

   Time frame: At baseline and after 12 weeks intervention

5. 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.

   Time frame: At baseline and after 12 weeks intervention

6. 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.

   Time frame: At baseline and after 12 weeks intervention

7. 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.

   Time frame: At baseline and after 12 weeks intervention

Secondary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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

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

7. 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.

   Time frame: At baseline and after 12 weeks of intervention

8. 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.

   Time frame: At baseline and after 12 weeks of intervention

9. 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.

   Time frame: At baseline and after 12 weeks of intervention

Other outcomes

1. Body Mass Index

   Body weight is measured with a digital scale to the nearest 0.1 kilogram and body height is measured with the participant standing against a wall. Both measurements are combined to calculate body mass index as weight divided by height squared, expressed in kilograms per square metre (kg/m\^2).

   Time frame: At baseline and after 12 weeks of intervention

2. Glycated haemoglobin

   Glycated haemoglobin is obtained by blood sampling or retrieved from the electronic health record, and reflects average blood glucose concentration over the preceding two to three month, expressed in %.

   Time frame: At baseline and after 12 weeks of intervention

Individual participant data

Plan to share: Yes