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Investigating the Acute Effect of Alternative Forms of Physical Activity in a Multi-ethnic Population

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ClinicalTrials.gov Identifier: NCT03549390
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study is a three period crossover design. There are three experimental conditions (yoga, continuous exercise and control) and participants will be randomised to one of six sequences requiring them to complete all three conditions.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigating the Acute Effect of Alternative Forms of Physical Activity in a Multi-ethnic Population: The Yoga Study
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Physical activity
Light-moderate intensity physical activities

Experimental: 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.
Behavioral: Physical activity
Light-moderate intensity physical activities

No Intervention: 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.



Primary Outcome Measures :
  1. Insulin area under the curve (AUC) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (height in metres)

  2. HbA1C [ Time Frame: Visit 1. Estimation up 1 week. ]
    glycated haemoglobin

  3. Full lipid profile [ Time Frame: Visit 1. Estimation up 1 week. ]
    HDL, LDL, cholesterol and triglyceride

  4. Quality of life [ Time Frame: Assessed via questionnaire at visit 1 and 6. Estimation up to 4-6 weeks. ]
    Quality of life will be measured by the EQ-5D. There are 5 questions and each question has 5 statements the participant may tick that best aligns with them e.g. I have no mobility problems, I have slight mobility problems walking, I have moderate problems in walking, I have severe problems in walking or I am unable to walk. These scores do not add up to a sum score and are not to be used cardinally. There is also a scale where participants rate how their overall health feels today by marking X on a scale from 1-100.

  5. Sociodemographic data [ Time Frame: Visit 1. Estimation up to 1 week. ]
    Sociodemographic data (age, sex, ethnicity, occupation, employment status, education level, household income, alcohol intake, smoking status, current medications, family medical history, current medications taken) via questionnaire. This will be completed by completing a question with a scale of boxes to tick e.g. ticking a box of listed suggestions which best describe the participants ethnicity or education level. Additionally, participants may be required to list answers to the questions e.g. list any current medications taken or age. This will all be measured in the baseline case report form.

  6. Physical function [ Time Frame: Visit 1. Estimation up to 1 week. ]
    measured by a series of physical tests. Handgrip strength by hand dynamometer.

  7. Physical fitness and suitability to exercise. [ Time Frame: Visit 1. Estimation up to 1 week. ]
    VO2 max test to measure cardiorespiratory fitness.

  8. 7-day food diary [ Time Frame: Administered at visit 1 and for the duration of week 1 of the study. Estimation up to 2 weeks. ]
    7-day food diary form

  9. Accelerometer wear time [ Time Frame: This will be during a 7-day period beginning from visit 1. Estimation up to 2 weeks. ]
    Accelerometer wear time/sleep diary form

  10. sleep diary [ Time Frame: This will be during a 7-day period beginning from visit 1. Estimation up to 2 weeks. ]
    Accelerometer wear time/sleep diary form

  11. Glucose area under the curve (AUC) [ Time Frame: 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. ]
    Glucose 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.

  12. Triglyceride AUC [ Time Frame: 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. ]
    Triglyceride 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.

  13. Free fatty acid AUC [ Time Frame: Assessed via 6 blood samples. This will be assessed at visit 3, 4 and 5. Estimation up to 6wks ]
    Free fatty acid 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.

  14. Positive affect (The Feeling Scale ) [ Time Frame: 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. ]
    Positive affect will be used to assess arousal of the physical activities during and after the interventions. Measured by on a scale of 1-5. e.g. 1 low arousal and 5 high arousal.

  15. Positive mood (The Felt Arousal scale) [ Time Frame: 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. ]
    Positive mood will be used to assess enjoyment of the physical activities during and after the interventions. Measured by a scale of -5-5. e.g. -5 very bad mood and 5 very good mood.

  16. Rating of perceived exertion (RPE) [ Time Frame: Assessed via a simple questionnaire during and after the exercise. Estimation up to 4-6 weeks. ]
    The Borg Rating of Perceived Exertion Scale (RPE) will record participants' perception of effort during the exercise bout. Measured by a scale of 6-21. e.g. 6 no exertion at all and 21 absolute maximum exertion.

  17. The modified Karolinska Sleepiness Scale [ Time Frame: 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. ]
    The modified Karolinska Sleepiness Scale will be used to plot participants' daytime sleepiness states throughout the experimental conditions. Measured on a simple question from 1-9. E.g. 1 = extremely alert and 9 = extremely sleepy, fighting sleep.

  18. Average blood glucose [ Time Frame: During visits 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Measured via Continuous Glucose Monitoring (CGM) device

  19. Time spent in hypoglycaemia [ Time Frame: During visits 3, 4 and 5. Estimation up to 4-6 weeks ]
    Measured via Continuous Glucose Monitoring (CGM) device

  20. Time spent in hyperglycaemia [ Time Frame: During visits 3, 4 and 5. Estimation up to 4-6 weeks ]
    Measured via Continuous Glucose Monitoring (CGM) device

  21. Adherence to the intervention [ Time Frame: Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks. ]
    Measured by accelerometer

  22. Sedentary time [ Time Frame: Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks. ]
    Measured by accelerometer

  23. Light intensity physical activity [ Time Frame: Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks. ]
    Measured by accelerometer

  24. Moderate to vigorous intensity physical activity (MVPA) [ Time Frame: Data during the intervention period will be compared to visit 1-2 Estimation up to 4-6 weeks. ]
    Measured by accelerometer

  25. Sleep [ Time Frame: Data during the intervention period will be compared to visit 1-2. Estimation up to 4-6 weeks ]
    Sleep will be derived from the accelerometer wear diaries

  26. 2-day food diary [ Time Frame: A 2-day food diary will be undertaken at each intervention condition (visit 3, 4 and 5). Estimation up to 4-6 weeks ]
    A 2-day food diary will be undertaken during intervention periods to try and standardise the food eaten the day before and immediately following the interventions.

  27. CGM log [ Time Frame: 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. ]
    CGM log to measure finger prick test scores and food eaten.

  28. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (weight in kilograms)

  29. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (waist circumference in centimetre)

  30. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (body fat in percentage)

  31. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (blood pressure in mm Hg)

  32. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (heart rate in beats per minute)

  33. Anthropometrics [ Time Frame: This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks. ]
    Anthropometric measurements (BMI [weight and height will be combined to report BMI] in kg/m2

  34. Depression [ Time Frame: This will be measured at visit 1 and 6. Estimation up to 4-6 weeks. ]
    Anxiety and depression will be measured by the hospital anxiety and depression scale. a score of 0-21 is given after they complete a simple question. there are 7 questions and each question has a maximum score of 3 and minimum of 0. a score 21 indicates high risk of depression and a score of 0 indicates on risk.

  35. Anxiety [ Time Frame: This will be measured at visit 1 and 6. Estimation up to 4-6 weeks. ]
    Anxiety and depression will be measured by the hospital anxiety and depression scale. a score of 0-21 is given after they complete a simple question. there are 7 questions and each question has a maximum score of 3 and minimum of 0. a score 21 indicates high risk of anxiety and a score of 0 indicates on risk.

  36. Physical function [ Time Frame: Visit 1. Estimated up to 1 week. ]
    measured by a physical test. Lower limb function (Sit-to-Stand Test) in one minute.

  37. Physical function [ Time Frame: Visit 1. Estimated up to 1 week. ]
    measured by a physical test. Balance (Functional Reach Test) test.

  38. Physical function [ Time Frame: Visit 1. Estimated up to 1 week. ]
    Measured by a physical test. Walking Test assessing normal walking speed over 20 metres

  39. Physical fitness and suitability to exercise. [ Time Frame: visit 1. Estimated up to 1 week. ]
    ECG at rest and during maximal exercise



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549390


Contacts
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Contact: Thomas Yates, PhD 0116 258 4312 ty20@le.ac.uk
Contact: Cameron Razieh, MSc 0116 258 8574 cr288@le.ac.uk

Locations
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United Kingdom
Leicester Diabetes Centre Recruiting
Leicester, Leicestershire, United Kingdom, LE5 4PW
Contact: Thomas Yates, PhD         
Contact: Cameron Razieh, MSc         
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03549390     History of Changes
Other Study ID Numbers: 0670
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Leicester:
Type 2 diabetes
ethnicity
physical activity
yoga

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases