Whole Body Vibration Therapy in Individuals With Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara Medipol University
About this trial
The aim of this interventional study is to investigate the effect of whole body vibration therapy on muscle oxygenation, vibration sensation, functional capacity and balance in individuals with Type 2 diabetes.
The main questions aimed to be answered are:
* Does whole body vibration therapy affect peripheral muscle oxygenation? * Does whole body vibration therapy improve vibration sense, functional capacity and balance compared to aerobic exercise? Participants' muscle oxygenation, vibration sensation, functional capacity and balance parameters will be assessed. They will participate in a whole body vibration therapy or aerobic training program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteering to participate in the research
Being diagnosed with type 2 diabetes
18 years of age or older
HbA1c level to be 6.5-10%
Disqualifiers
Previous or concurrent psychiatric, neurological, orthopedic or systemic illness
Use of insulin in treatment
Diabetic neuropathy
Foot ulcer
Trial design
Design model
Parallel
Treatments tested in this trial
Whole Body Vibration
Other interventionEach exercise session will be performed with a frequency of 30 Hz and an amplitude of 2 mm. Participants are in a 110° squat position on the platform (the degree will be adjusted using a goniometer). Participants will exercise for 16 minutes from week one to week three, 20 minutes from week four to week six and 24 minutes from week seven to week eight, respectively (8 iterations and 1 minute of vibration with 1 minute interval between each iteration)
Aerobic Exercise
Other interventionFrom week one to week three, from week four to week six and from week seven to week eight, the participants will exercise for 30 minutes (5 minutes of running at 60-70% of heart rate and 5 minutes of active rest at 30-45% of maximum heart rate), 42 minutes (7 minutes of running at 60-70% of heart rate and 7 minutes of active rest at 30-45% of maximum heart rate) and 60 minutes (10 minutes of running at 60-70% of heart rate and 10 minutes of active rest at 30-45% of maximum heart rate). The exercise sessions consist of warm-up, main program and cool-down phases.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Aerobic ExerciseExperimental treatment 1 intervention
Group B: Whole Body VibrationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Muscle Oxygenation
Vastus lateralis muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT)
Time frame
8 weeksSecondary outcomes
1
Vibration sense
The sense of vibration will be assessed with a 128 Hz diapason. The lower end of the device will be brought into contact with the plantar surface of the first metatarsal bone, the medial malleolus, and the medial tuberosity of the tuberositas tibia in both lower extremities of the individual. The moment the diapozone touches the tested areas will be considered as the zero-second (0th second, start), and the test will be terminated when the individual perceives that the vibration disappears completely and the time will be recorded in seconds. Three trials will be performed on the areas in both lower extremities, and the average will be reported.
Time frame
8 weeks2
The Timed Up & Go Test
It is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability that can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The TUG test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down.
Time frame
8 weeks3
The 6 minute walk test
The individual is asked to walk on a certain track for 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.
Time frame
8 weeks4
The 30-second Chair Stand Test
In a chair with a sitting height of 43.2 cm and a back supported, the patient is asked to sit and stand as quickly as possible. The patient sits in the chair. They cross their hands on their chest. Before the test, 2 attempts are made. The number of sitting down times is noted by keeping a 30-second timer with a stopwatch. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ankara Medipol University
Lead sponsor
Gazi University
Collaborator
Source ClinicalTrials.gov