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

NCT03549390 | Completed

• 1 other identifier: 0670
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; ethnicity; physical activity; yoga

Outcome Measures

Primary Outcomes (1)

• Insulin area under the curve (AUC)

  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.

  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.

Secondary Outcomes (39)

• Anthropometrics

  This will be measured at visit 1, 3, 4 and 5. Estimation up to 4-6 weeks.

• HbA1C

  Visit 1. Estimation up 1 week.

• Full lipid profile

  Visit 1. Estimation up 1 week.

• Quality of life

  Assessed via questionnaire at visit 1 and 6. Estimation up to 4-6 weeks.

• Sociodemographic data

  Visit 1. Estimation up to 1 week.

Study Arms (3)

Yoga

EXPERIMENTAL

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

Continuous exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Physical activity BEHAVIORAL

Light-moderate intensity physical activities

Continuous exercise; Yoga

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Leicester Diabetes Centre

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 8, 2018
• Study Start: October 30, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 1, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)