RecruitingACTRN12622001052729

Whole body vibration exercise and type 2 diabetes

Investigating the impact of whole body vibration exercise on exercise capacity and glycaemia in type 2 diabetes

Sponsor

Deakin University

Enrollment

40 participants

Start Date

May 22, 2023

Study Type

Interventional

Conditions

Diminished exercise capacity Hyperglycaemia

Summary

Reduced exercise capacity is a condition of decreased ability to perform physical exercise and is common in people with type 2 diabetes. This causes a range of problems such as fatigue, pain, nausea, breathlessness, and severe muscle cramps. Reduced exercise capacity significantly reduces quality of life making independent living difficult. We have established that poor blood flow in the smallest blood vessels (microvascular) in skeletal muscle, and not problems with the heart, is the main driver of impaired exercise capacity in type 2 diabetes. We have also demonstrated that people with type 2 diabetes have poor blood glucose (glycaemic) responses to meals which is at least in part due to impairments in microvascular responses in skeletal muscle. Traditional exercise training has been demonstrated to improve exercise capacity and glycaemic regulation. Although effective, traditional exercise programs are not widely used to treat type 2 diabetes because most patients cannot or choose not to participate despite the recognised benefits. Other “exercise mimetic” vascular therapies are therefore required to assist people with type 2 diabetes. One promising novel approach is whole body vibration exercise. We will investigate whether home-based whole body vibration exercise (using a commercial vibration platform) for 3 months can improve exercise capacity and glycaemic regulation in people with type 2 diabetes compared to usual care.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

People with type 2 diabetes often have reduced exercise capacity — meaning they tire quickly and struggle with physical activity — due to poor blood flow in the tiny blood vessels of their muscles. This makes it hard to exercise, yet exercise is one of the best ways to manage blood sugar and cardiovascular health. Whole body vibration (WBV) is a passive form of exercise where a person stands or sits on a vibrating platform; it stimulates muscles and blood vessels without requiring strenuous physical effort. This study tests whether 3 months of home-based WBV therapy (using a commercial vibration platform) improves exercise capacity and blood sugar control in people with type 2 diabetes who manage their condition with diet or oral medication. Participants are randomly assigned to WBV therapy or usual care. Fitness tests, blood glucose measures, and vascular assessments are taken before and after the program. You may be eligible if you are aged 40–80, have a diagnosis of type 2 diabetes managed without insulin, weigh under 180 kg, and do not have serious cardiovascular, limb, or musculoskeletal conditions. Current or recent smokers, those already in a structured exercise program, and those with a history of cancer in the past 5 years are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This study is a single-site two-armed, parallel, randomized controlled trial comparing the effect of 3 months of home-based vibration exercise training to usual care. PRE-INTERVENTION TESTING: Cli

This study is a single-site two-armed, parallel, randomized controlled trial comparing the effect of 3 months of home-based vibration exercise training to usual care. PRE-INTERVENTION TESTING: Clinical chemistries and anthropometrics: Fasting clinical chemistries (glucose, insulin, lipid profile, HbA1c, lactate) will be measured. Medical, lifestyle, quality of life, and dietary questionnaires will be used to assess overall health, physical activity, quality of life, and dietary habits. A 6-minute walk test will be conducted to assess functional exercise capacity. Vascular function and metabolic responses to both exercise stress testing and mixed nutrient meal ingestion will be performed before and after a 3-month intervention (home-based vibration exercise training or usual care). Exercise Doppler-echocardiogram: Graded exercise testing will be performed on an exercise bike using standard cardiopulmonary stress equipment and symptom limited graded exercise test protocol. Resting and post-exercise echocardiographic assessment will be performed using a commercial ultrasound machine at rest and during exercise testing. Microvascular responses in skeletal muscle during exercise and after mixed nutrient meal ingestion: Microvascular blood flow responses will be tested via contrast enhanced ultrasound imaging of thigh muscle at rest, at the end of the exercise stress tests, and during and after ingesting a mixed nutrient meal. Large artery function and central haemodynamics: Femoral artery blood flow will be assessed using 2D and Doppler imaging at rest, at the end of the exercise stress tests, and during and after ingesting a mixed nutrient meal. Mixed nutrient meal: Participants will be provided a mixed nutrient meal (300 Calories) to consume within 5 minutes. Each testing session will take 2-3 hours and will be supervised by someone from the research team (cardiovascular or exercise physiologist). WHOLE BODY VIBRATION EXERCISE INTERVENTION (3 months): Participants will undergo whole body vibration exercise 4 days per week for 3 months. The training is designed to perform static work on the legs. Participants will stand on a commercially available platform. For the first 4 weeks, training will be carried out for 10 min per session. For weeks 5-8, training will be increased to 15 min per session. For weeks 9-12, training will be increased to 20 min per session. Participants will be loaned a platform to take home. Participants will be asked only to maintain their usual daily activities in addition to the vibration training (i.e. no additional exercise). Adherence to the intervention will be via a vibration exercise diary and contact from the research team every 2 weeks via email or phone. MID-INTERVENTION EXERCISE TESTING (after 6 weeks): After 6 weeks of the intervention, participants will be asked to attend a single session at Deakin University to undergo a 6-minute walk test and a maximal exercise test on a gym bike. No ultrasound measures or blood will be taken during this visit. Aerobic capacity (exercise tolerance) will be measured via a face-mask during the maximal exercise test. POST-INTERVENTION TESTING: Participants will repeat the same mixed meal challenge and exercise tests as performed in the pre-intervention visits. These visits will be conducted a minimum of 48 hours after the final training session to eliminate the effects of any prior exercise bout.