Cost-effectiveness of a whole-body vibration program in patients with type 2 diabetes: A retrospective study protocol

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a chronic disorder, with patients exhibiting hyperglycemia in fasting and postprandial states. T2DM has several complications, including loss of sensation in more distal body parts. Good peripheral sensitivity is essential as this affects different parameters related to activities of daily living, such as leg strength and balance. The objectives of this project were to assess the effects of an 8-week whole-body vibration (WBV) training program on (1) vibration perception threshold (VPT), (2) balance, (3) strength, (4) lipidic profile, (5) health-related quality of life, (6) diabetic neuropathy, and (7) body composition in T2DM patients. Methods/Design: A double-blind, randomized controlled study, with WBV and placebo groups, was carried out. Both groups performed 8 weeks of intervention, with 3 sessions per week, completing a total of 24 sessions. There were two groups: the experimental group, i.e., the WBV group, who received WBV therapy; and the placebo group, who completed a simulated training program that was developed on a Galileo Fitness platform, connected to software displayed on a screen. The participant could see the parameters of the simulated vibration training (duration, amplitude, and frequency), but it was the software that controlled the speakers placed inside the vibration platform. Ninety patients with T2DM (56 males and 34 females) were recruited for the intervention. Participants were assigned equally to the WBV (n = 45) and placebo (n = 45) groups. Primary outcome measures were (1) HbA1c and (2) vibration threshold. Secondary measures were (1) health-related quality of life, (2) balance, (3) strength, (4) body composition, (5) blood pressure, (6) diabetic neuropathy, and (7) lipidic profile. Statistical analysis was carried out by treatment intention and protocol. Discussion: This project aimed to investigate the effects of WBV training on HbA1c, vibration threshold, and incremental cost-effectiveness ratio in T2DM patients. In future, guidelines will be provided for the incorporation of the main obtained conclusions into the social-sanitary system and businesses.