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A whole-body vibration program in type 2 diabetic patients

Cost-effectiveness of a whole-body vibration program in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16866781
Enrollment
90
Registered
2013-11-01
Start date
2013-04-08
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes type 2 Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Two groups: Experimental group and placebo group. Experimental group: 24 sessions of whole-body vibration of 15 minutes per sessions, three times per week during 2 months. Placebo group: 24 sessions

Sponsors

University of Extremadura (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female, 40 to 85 years old, diagnosed with type 2 diabetes 2. Agreement to volunteer for the study by giving a written informed consent

Exclusion criteria

Exclusion criteria: 1. Contraindications to high intensity exercise participation: 1.1. Retinopathy 1.2. Musculoskeletal limitations 1.3. Severe balance impairments 1.4. High risk of thrombosis 2. Psychotropic and neurotoxic drugs intake 3. Exposure to neurotoxins (industrial accidents, contact with toxic dumps) 4. Radiotherapy treatment 5. High risk of non-diabetic neuropathy (AIDS, uremia, alcoholism) 6. People who have or have had a job with high exposure to whole-body mechanical vibration 7. Individuals undergoing or have completed a whole-body vibration program

Design outcomes

Primary

MeasureTime frame
1. HbA1c. Measured with laboratory blood analysis at baseline and two months. 2. Vibration threshold. Measured with biothensiometer (vibraton II) at baseline, acute effects, one month and two month.

Secondary

MeasureTime frame
1. Health related quality of life. Measured with EQ-5D-5L; SF-12; 15-D, Diabetes Quality of Life Measure (DQOL) and Foot Health Status Questionnaire (FHSQ). Measured at baseline and two months. 2. Balance. Measured with plate force (Romberg test open and closed eyes), Time and Go test (TUG). Measured at baseline and two months. 3. Strength. Measured with Chair and stand test, BMI, Tilts and stadiometer (Soehnle professional). Measured at baseline and two months. 4. Muscular and Fat percentage. Measured with impedance meter (Tanita) at baseline and two months. 5. Blood pressure. Measured with doppler at baseline and two months. 6. Lipidic profile. Measured with laboratory blood analysis at baseline and two months. 7. Diabetic neuropathy. Measured with Michigan Neuropathy Screening Instrument and monofilament at baseline and two months. 8. Body mass index (BMI). Measured at baseline and two months.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026