Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/12/2019
Date assigned
09/12/2019
Last edited
12/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Adults with type 2 diabetes mellitus (T2DM) have physiologic exercise limitations and decreased cardiorespiratory fitness which may contribute to frailty. Frailty is a pre-disability condition linked to reduced physical function. While frailty and physical impairment is more prevalent in an older population, it has been shown that it is also common in middle-aged people with T2DM. Poor physical function and frailty is independently associated with increased risk of hospitalisation, disability and morbidity. Exercise is highly effective at counteracting the decline in physical functioning related to T2DM. Exercise has multiple benefits for patients with T2DM including reduced risk of chronic diseases, such as cardiovascular diseases, and increased life expectancy and quality of life. While frailty is considered as a predictor of future disability, it might be modifiable, particularly at early stages of functional decline. Nevertheless, there is a significant lack of intervention studies aimed to reduce functional decline in patients with T2DM. Therefore, this study aims to investigate the effect of a multi-modal exercise intervention on people with T2DM and impaired physical function.

Who can participate?
Adults with T2DM, aged between 40 and 70 years with low physical function

What does the study involve?
Participants will be randomised to either the exercise group or the control group with no exercise intervention. Participants in the exercise group attend two supervised exercise sessions per week in Leicester Diabetes Centre for eight weeks. Each session lasts up to 60 minutes and incorporates resistance exercise and moderate-intensity aerobic exercise together with balance and stretching exercises. Alongside the two weekly supervised exercise sessions, participants are prescribed an additional home-based exercise session. These sessions are tailored to the needs of the individual and their ability to perform the exercise.

What are the possible benefits and risks of participating?
Participants allocated to the exercise intervention group will be prescribed an exercise programme tailored to their needs by an exercise physiologist. Participants will receive their results from each assessment visit about their health profile and fitness that would be expensive if done privately. This study is a non-invasive lifestyle modification study based on exercise in type 2 diabetes, therefore there is a small possibility that episodes of hypoglycaemia (low blood sugar) may occur during or after exercise training. Glucose levels will be checked before all exercise sessions in those taking insulin and sulphonylureas, Additionally, a warm-up and cool-down period will be also performed before and after each exercise session to avoid the risk of injury.

Where is the study run from?
University Hospitals of Leicester NHS Trust (UK)

Who is funding the study?
Leicester NIHR Biomedical Research Centre and NIHR Senior Investigator Funds

Who is the main contact?
Miss Monika Mickute
mm856@leicester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Monika Mickute

ORCID ID

Contact details

Leicester Diabetes Centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 8572
Mm856@leicester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43022, IRAS 261435

Study information

Scientific title

The effect of a multi-modal exercise intervention on patients with type 2 diabetes and impaired physical functioning: a randomised controlled trial

Acronym

RESET

Study hypothesis

Adults with type 2 diabetes mellitus (T2DM) have physiologic exercise limitations and decreased cardiorespiratory fitness which may contribute to frailty. Frailty is a pre-disability condition linked to reduced physical function. While frailty and physical impairment is more prevalent in an older population, it has been shown that it is also common in middle-aged people with T2DM. Poor physical function and frailty is independently associated with increased risk of hospitalisation, disability and morbidity. Exercise is highly effective at counteracting the decline in physical functioning related to T2DM. Exercise has multidimensional benefits for patients with T2DM including reduced risk of chronic diseases, such as cardiovascular diseases, increased life expectancy and quality of life. While frailty is considered as a predictor of future disability, it might be modifiable, particularly at early stages of functional decline. Nevertheless, there is a significant lack of intervention studies aimed to reduce the functional decline in patients with T2DM. Therefore, this study aims to investigate the effect of a multi-modal exercise intervention on people with T2DM and impaired physical function.

Ethics approval

Approved 24/09/2019, South Central - Berkshire B Research Ethics Committee (The Old Chapel Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)207 104 8310, +44 (0)207 104 8199; Email: nrescommittee.southcentral-berkshireb@nhs.net), REC ref: 19/SC/0418

Study design

Randomised; Interventional; Design type: Prevention, Physical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Type 2 diabetes mellitus

Intervention

Participants will be randomised to either the exercise group or the control group with no exercise intervention. Participants in the exercise group will attend two supervised exercise sessions per week in Leicester Diabetes Centre for eight weeks. Each session will last up to 60 minutes and incorporate resistance exercise and moderate-intensity aerobic exercise together with balance and stretching exercises. Alongside the two weekly supervised exercise sessions, participants will be prescribed an additional home-based exercise session. These sessions will be tailored to the needs of the individual and the ability to perform the exercise.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Physical function assessed by the incremental shuttle walk test (ISWT) and the modified physical performance test (PPT) pre and post the 8-week intervention

Secondary outcome measures

1. Lower body endurance assessed with the short physical performance battery (SPPB) test which involves balance, walking seed and ability to sit and stand from a chair. These assessments will be done pre and post the 8-week intervention
2. Postural stability ((pressure path area (mm2) and sway velocity (mm/s)) assessed with Fysiometer force plate pre and post the 8-week intervention
3. Sit-to-stand-60 test (STS-60) will be used to measure how many times the participant can stand from a chair in 60 seconds pre and post the 8-week intervention
4. Lower limbs muscle strength (isometric and isokinetic quadriceps strength) measured using a fixed dynamometer (Biodex) pre and post the 8-week intervention
5. Handgrip strength measured using a digital handheld dynamometer pre and post the 8-week intervention
6. Cross-sectional area of muscle, echo intensity (indication of intermuscular adipose tissue), fibre pennation angle, muscle, and subcutaneous fat thickness, and volume of lower limb muscles such as the rectus femoris (quadriceps) assessed with ultrasound imaging pre and post the 8-week intervention
7. Mechanical and viscoelastic (tone, elasticity and stiffness) characteristics of the quadriceps muscle assessed using myotonometery (MyotonPRO) pre and post the 8-week intervention
8. Cardio-metabolic health and renal status assessed by a blood sample analysed for HbA1c, glucose, insulin and blood lipids (total cholesterol, high-density lipoprotein cholesterol, non-esterified fatty acids and triglycerides) and creatinine. Markers of inflammation also assessed by a blood sample analysed for C-reactive protein. These will be taken from venous blood while under fasting conditions both pre and post the 8-week intervention
9. Body composition assessed with dual-energy X-ray absorptiometry (DEXA) scanning which will derive a breakdown of body fat, muscle mass and bone density. Bodyweight, height, waist circumference will be also measured both pre and post the 8-week intervention
10. Glycaemic variability, such as time in hypoglycaemia assessed with flash glucose monitoring (FGM) two weeks before the intervention and two weeks after the 8-week intervention
11. Resting metabolic rate (RMR) measured with indirect calorimetry under fasted and resting conditions pre and post the 8-week intervention
12. Objectively measured habitual physical activity assessed with accelerometers throughout the duration of the intervention. Accelerometers will capture various measures, including time being sedentary, time in high-intensity exercise, etc
13. Dietary intake assessed with UK Diabetes and Diet Questionnaire (UKDDQ) both pre and post the 8-week intervention
14. Physical activity assessed using Recent Physical Activity Questionnaire (RPAQ) pre and post the 8-week intervention
15. Quality of life assessed through a number of health-related quality of life questionnaires (the EQ5D-5L instrument, the Hospital Anxiety and Depression scale and the Diabetes Distress Scale -17, The World Health Organization Disability Assessment Scale II) pre and post the 8-week intervention
16. The effect of breathlessness on daily activities assessed using the MRC breathlessness scale pre and post the 8-week intervention

Overall trial start date

18/07/2019

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males and females aged 40-70 years
2. BMI 25 to 40 kg/m2 (23 to 40 kg/m2 in individuals of south Asian ethnicity)
3. Patients with established T2DM (> 6 months since diagnosis)
4. SPPB 1 to 9

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. Unable to consent
2. Persons unable to understand written and spoken English sufficiently to consent and participate fully in the study
3. Participating in other interventional studies
4. Recent history of stroke, myocardial infarction, unstable angina, congestive heart failure within 12 months
5. Uncontrolled hyperglycaemia (HbA1c > 10% - established through medical notes or confirmed through baseline blood sample results)
6. Stage 4 or 5 chronic kidney disease (eGFR < 30ml/min/1.73m2)
7. Chronic obstructive pulmonary disease
8. Heart failure
9. Terminal illness (life expectancy less than 1 year)
10. Patients with type 1 diabetes
11. Current smokers (having quit less than 1 year before entering the study)
12. Weight unstable within the past 6 months (> = 10 kg)
13. Unable to perform exercise testing/training
14. Taking part in regular (at least once a week) strenuous sport or activities (> 120 minutes self-reported exercise per week)

Recruitment start date

01/01/2020

Recruitment end date

01/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Of Leicester NHS Trust
Leicester Royal Infirmary Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

c/o Michelle Muessel
Research Governance Office - Academic dept
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); NIHR Leicester Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/03/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/05/2020: A typographical error was corrected in the plain English summary. 02/12/2019: Trial's existence confirmed by the NIHR.