Investigating the Acute Effect of Alternative Forms of Physical Activity in a Multi-ethnic Population: The Yoga Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Insulin area under the curve (AUC)
研究概览
简要总结
The amount of people with diabetes has now reached over 4 million in the United Kingdom. Type 2 Diabetes accounts for the majority of all cases of diabetes and increases the risk of many other diseases, such as heart disease.
Research has shown that individuals from South Asian descent have elevated risk of certain chronic diseases, such as type 2 diabetes and cardiovascular disease. The risk of developing these diseases can be reduced by engaging in a healthy lifestyle. One component of a healthy lifestyle is engaging in physical activity. However, previous research has shown that South Asian individuals engage in less physical activity, compared to other ethnicities. It is not yet wholly understood why South Asians engage in less physical activity, but it is vitally important to try and find new ways to increase South Asian physical activity levels. Therefore, the investigators have worked with South Asian communities in identifying culturally appropriate forms of physical activity. From this, yoga and walking were identified as two forms of culturally appropriate physical activity. This study will test and compare whether yoga and light intensity walking can be effectively used in the prevention of type 2 diabetes. The results of this study will help the investigators and health policy makers understand how South Asians and other ethnicities respond to exercise, the therapeutic benefits of yoga and help inform future diabetes prevention programmes within multi-ethnic communities.
详细描述
Physical activity, commonly defined as any movement of skeletal muscle that requires low-mid level energy expenditure has long been associated with improving cardiometabolic health. Furthermore, increased PA has more recently been associated with decreased all-cause and chronic disease mortality. Evidence on lifestyle risk factors such as PA continues to grow and demonstrate associations with improved health. Interestingly, evidence has suggested type 2 diabetes is a 'lifestyle disease', with 80-90% of the prevalence in any given ethnic group explained by lifestyle and environmental factors. This suggests lifestyle factors, such as PA and diet may play a pivotal role in the prevention and management of T2D. The number of individuals with diabetes has risen from 108 million in 1980 to 425 million in 2017, with global prevalence in over 18 year olds rising from 4.7% to 8.5% in the same time period. This illustrates the importance of PA in preventing and managing T2D.
Diabetes is a disease characterised by chronic hyperglycaemia with disturbances to carbohydrate metabolism, resulting from the body's impaired ability to produce or respond to insulin. Diabetes can lead to a number of complications which can reduce a person's quality of life and life expectancy. The main cause of premature mortality with diabetes is cardiovascular disease. Insulin resistance is suggested to be the predominant factor in the aetiology of T2D. PA has been shown to be a stimulator of insulin sensitivity, both acutely and chronically. Epidemiological data on PA (and other lifestyle habits) and T2D is important as it provides associations between exposures and the disease. This research can give a sense of an association and where robust evidence reinforces these associations, it can be the starting point for initiating disease prevention programmes based on reducing/increasing exposure to the risk/preventative factor.
A systematic review and network meta-analysis of lifestyle, pharmacological and surgical interventions stated that lifestyle interventions, which included exercise, are beneficial in reducing the risk of developing T2D, compared to standard care. When focusing on lifestyle interventions, diet plus exercise plus pedometer had the highest probability of being effective (HR 0.35 95% CI [0.11-1.14]). Exercise had the second highest probability of being the most effective lifestyle intervention (HR 0.51 95% CI [0.33-0.82]). The Indian Diabetes Prevention Programme found improved lifestyle significantly improved cardiometabolic health in a 42-month study. Improved lifestyle accounted for educational sessions revolving around improving diet and then engaging in PA. When comparing control, metformin, lifestyle and lifestyle + metformin groups it was found metformin, lifestyle and lifestyle & metformin groups significantly delayed time to diabetes, compared to control. The two groups that involved positive lifestyle changes delayed time to diabetes marginally longer than the metformin group. The solely lifestyle group delayed time to diabetes the longest over the entire 42-month period. Similarly, The Diabetes Prevention Program found that incorporating positive lifestyle changes significantly reduced the cumulative incidence of T2D, compared to metformin and placebo groups. The lifestyle group were instructed to engage in 150min.week-1 of PA. There was a 58% reduction in incidence of T2D in the lifestyle group, compared to placebo, in a 4-year follow-up. When participants were split into their respective ethnicities, American Indians and Asians saw the greatest reductions in T2D incidence. At 10 year post trial follow up, the lifestyle group still had significantly lower cumulative incidence of T2D.
The molecular mechanisms by which PA affects insulin have been heavily researched. In brief, after one bout of exercise there is an immediate increase in glucose uptake to the skeletal muscle, which is in response to muscle contraction. This increase is thought to be due to increased GLUT-4 translocation to the cell surface, which increases insulin sensitivity. Additionally, exercise may increase oxidative metabolism in mitochondria in the skeletal muscle. An increase in the size and number of mitochondria in the cells improves oxidative capacity, decreasing the amounts of TG and fatty acids. TG and fatty acids interfere with the insulin signalling process, which may cause insulin resistance. This reiterates the importance of PA in T2D prevention and management. Additionally, physical inactivity and sedentary behaviour have both been noted to disrupt normal metabolic state and chronically increase insulin resistance/decrease insulin sensitivity.
Other mechanisms that PA may improve T2D by are improving lipoprotein profile, endothelial function (and subsequently hypertension), reducing obesity and increasing anti-inflammatory effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •≥18 to ≤75 years of age
- •HbA1c >5.7% and BMI ≥23kg/m2* / ≥25kg/m2 (WE) OR BMI ≥27.5kg/m2* / ≥30kg/m2 (WE)
- •Do not engage in regular sports or strenuous physical activity
- •Able to walk and use a treadmill (to engage in light-moderate physical activity)
- •No medical conditions that affect balance and ability to undertake yoga postures
- •No other current medical conditions
- •Ability to communicate in and understand English to participate in the informed consent process *Cut off points for BME background individuals
排除标准
- •Engage in regular purposeful sport or strenuous leisure time exercise (>120 minutes self-reported exercise per week)
- •HbA1c >8.0%
- •Use of glucose lowering medication
- •Inability to stand or undertake light-moderate physical activity.
- •Diagnosed psychological condition that limits the psychological outcome component of the study (e.g. depression)
- •Ongoing CVD
- •Steroid abuse
- •Current smoker
- •Pregnant/lactation
- •Inability to understand English
- •Inability to give informed consent
研究组 & 干预措施
Yoga
The yoga session will be held in a room where lighting, temperature and music can be regulated. The session will be led by a trained instructor and involve a combination of body postures, breathing techniques and meditation. There will be a series of progressive breath centred yoga poses named Sun Salutations A & B for participants to complete, which have been chosen based on PPI and current relevant yoga practices. Sun Salutations A & B will be completed in a continuous sequence and aim to be completed with one breath per pose, but can be modified based on participant ability.
干预措施: Physical activity (Behavioral)
Continuous exercise
The exercise will be 30 minutes of treadmill walking. During the initial stages of walking, participants will gradually be taken up to a speed that registers between 10 and 12 on the Borg Rating of Perceived Exertion (RPE) Scale, up to a maximum of 4.0 km/h. This speed will be fixed for the entire exercise period. This exercise intensity has been chosen as it is the exercise intensity matched to light-moderate physical activity.
干预措施: Physical activity (Behavioral)
Control
Participants will remain sitting throughout the test period whilst undertaking typical sedentary behaviours such as watching TV, using a computer, reading and writing. Walking and standing will be restricted.
结局指标
主要结局
Insulin area under the curve (AUC)
时间窗: Assessed via 6 blood samples at visit 3, 4 & 5.Two samples will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following a breakfast meal. This will be assessed for all of the 4.5 hour experimental treatment conditions.
Insulin AUC will be used to assess whether, following the intervention, the expected improvement in glucose metabolism is maintained or improved in the post-measurement conditions compared to the pre-measurement conditions.
次要结局
- Physical fitness and suitability to exercise.(visit 1. Estimated up to 1 week.)
- HbA1C(Visit 1. Estimation up 1 week.)
- Full lipid profile(Visit 1. Estimation up 1 week.)
- Accelerometer wear time(This will be during a 7-day period beginning from visit 1. Estimation up to 2 weeks.)
- Glucose area under the curve (AUC)(Assessed via 6 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following a breakfast meal. This will be assessed at visits 3, 4 and 5. Estimation up to 4-6 weeks.)
- Positive affect (The Feeling Scale )(Assessed via a simple questionnaire at 6 time points. This will be completed at the same time as the blood samples. This will be assessed at visits 3, 4 and 5. Estimation up to 4-6 weeks.)
- Sedentary time(Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks.)
- Sociodemographic data(Visit 1. Estimation up to 1 week.)
- Quality of life(Assessed via questionnaire at visit 1 and 6. Estimation up to 4-6 weeks.)
- sleep diary(This will be during a 7-day period beginning from visit 1. Estimation up to 2 weeks.)
- 7-day food diary(Administered at visit 1 and for the duration of week 1 of the study. Estimation up to 2 weeks.)
- Triglyceride AUC(Assessed via 6 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following a breakfast meal. This will be assessed at visits 3, 4 and 5. Estimation up to 4-6 weeks.)
- Free fatty acid AUC(Assessed via 6 blood samples. This will be assessed at visit 3, 4 and 5. Estimation up to 6wks)
- Adherence to the intervention(Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks.)
- Sleep(Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks)
- 2-day food diary(A 2-day food diary will be undertaken at each intervention condition (visit 3, 4 and 5). Estimation up to 4-6 weeks)
- CGM log(While wearing the CGM (during visits 3, 4 and 5), participants will be requested to complete 4 finger prick tests per day. This will be for each intervention condition. Estimation up to 4-6 weeks.)
- Depression(This will be measured at visit 1 and 6. Estimation up to 4-6 weeks.)
- Anxiety(This will be measured at visit 1 and 6. Estimation up to 4-6 weeks.)
- Positive mood (The Felt Arousal scale)(Assessed via a simple questionnaire at 6 time points. This will be completed at the same time as the blood samples. This will be assessed at visits 3, 4 and 5. Estimation up to 4-6 weeks.)
- Rating of perceived exertion (RPE)(Assessed via a simple questionnaire during and after the exercise. Estimation up to 4-6 weeks.)
- The modified Karolinska Sleepiness Scale(Assessed via a simple questionnaire at 6 time points. This will be completed at the same time as the blood samples. This will be assessed for all of the 4.5 hour experimental treatment conditions. Estimation up to 4-6 weeks.)
- Average blood glucose(During visits 3, 4 and 5. Estimation up to 4-6 weeks.)
- Time spent in hypoglycaemia(During visits 3, 4 and 5. Estimation up to 4-6 weeks)
- Time spent in hyperglycaemia(During visits 3, 4 and 5. Estimation up to 4-6 weeks)
- Light intensity physical activity(Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks.)
- Moderate to vigorous intensity physical activity (MVPA)(Data during the intervention period will be compared to visit 1-2 Estimation up to 4-6 weeks.)
- Anthropometrics(This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks.)
- Physical function(Visit 1. Estimated up to 1 week.)
- Physical function(Visit 1. Estimation up to 1 week.)
- Physical fitness and suitability to exercise.(Visit 1. Estimation up to 1 week.)