None listed
Conditions
Brief summary
The aim of the current study is to assess the feasibility, safety and effectiveness of a 12-wk WBV intervention on glycemic control, lipid-related cardiovascular risk factors, blood flow, body composition, balance and functional capacity among T2DM patients in a primary care context and to quantify the possible relationship between glycemic control and functional capacity, between blood flow and body composition, and between balance and physical performance among Type 2 diabetes mellitus (T2DM) participants receiving the new intervention. Sixty participants will be randomly assigned to either a whole body vibration group (WBV) or usual-care control group (CON). In addition to demographic information and clinical details, body composition (waist and hip circumference –WHR-, weight, height, percentage of body fat and fat-free mass) and blood flow (femoral artery diameter, maximum systolic velocity –VS-, maximum diastolic velocity –VD-, time averaged mean –TAM-, heart rate –HR-, pulsatility index –PI- and resistance index –RI-, mean velocity –Vmed-, peak blood velocities –TPVM- and acceleration time to peak flow –Tacel-); glycated hemoglobin -HbA1c-, fasting blood glucose, lipid-related cardiovascular risk factors (i.e. cholesterol, triglycerides, HDL, LDL, LDL/HDL and atherogenic index) and functional capacity as measured by time up and go -TUG- test, 6-minute walking test-T6MW and 30s-sit to stand-30s-STS- and measurement of center of pressure (COP) excursions in the anteroposterior (AP) and mediolateral (ML) directions, will be assessed at baseline and after the 12-week intervention. These findings may have important implications for primary healthcare-based diabetes fall prevention.
Interventions
Participants will be involved in a 12-week WBV-based program on a side-alterning vibration platform (Phyisio Wave 700, Globus, Italy) comprising three sessions per week, one day between off sessions. All sessions will be conducted one-on-one with a physical therapist. Each exercise session was performed through the frequency of 12 Hz for the first month, 14 Hz for the second month and 16 Hz for the last month. Peak to peak displacement of 4 mm was maintained during the whole program. Participant
Participants will be involved in a 12-week WBV-based program on a side-alterning vibration platform (Phyisio Wave 700, Globus, Italy) comprising three sessions per week, one day between off sessions. All sessions will be conducted one-on-one with a physical therapist. Each exercise session was performed through the frequency of 12 Hz for the first month, 14 Hz for the second month and 16 Hz for the last month. Peak to peak displacement of 4 mm was maintained during the whole program. Participants must adopt an isometric squat position during all exposures, with knees flexed at 100 degrees during 30 s. After that, subjects will be asked to perform 8 exercises on the vibration platform (lunge, step up and down, squat, calf raises, left and right pivot, shoulder abduction with elastic bands, shoulder abduction with elastic bands while squatting, arm swinging with elastic bands) with slow movements at a rate of 2s for both concentric and eccentric phases. For the first month, the duration of exercises was 30s with a recovery time of 30 s between exercises. For the second and third month, duration of exercises will be increased up to 45s and 60s respectively with a maintained recovery time of 30s. Therefore a typical session will last approximately 20 min. To ensure a correct and safety increase in intensity through the program, each first day of intensity increase, a pre-exercise, post-exercise and post 48h fasting blood glucose control will be performed in each patient.
Sponsors
University of Seville
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants had to have T2DM confirmed by a primary care provider and based on the ADA diagnostic criteria.
Exclusion criteria
Exclusion criteria included history or evidence of advanced cardiovascular, renal or hepatic diseases, diabetic retinopathy, nephropathy, or neuropathy, insulin use, orthopedic or other limitations that may interfere with their ability to exercise safely. Participants with HbA1c >10% also were omitted. Moreover, participants receiving physical therapy were excluded to avoid possible interactions with the present trial.
Outcome results
None listed