Plain English Summary
Background and study aims
There are 3.7 million people in the UK with diagnosed diabetes (both Type 1 and Type 2), with approximately 80% treated with insulin or requiring insulin treatment at some stage of the disease. While diabetes complications such as cardiovascular disease are well known, often unappreciated complications are the accelerated rate of sarcopenia (loss of bone mass), increased frailty, and loss of independence that can come from years of exposure to hyperglycaemia and inflammation.
Leading a physically active life can be problematic for those with insulin-treated diabetes due to blood glucose control disruption. However, resistance (weight) training carries less risk of a loss of blood glucose control, compared to other forms of exercise. Moreover, in other groups of people with frailty, resistance training has been shown effective in improving physical function. With the increasing prevalence of diabetes, planning for the management of this patient group in later life is vital.
The aim of this study is to test the use of resistance exercise to improve physical function in older patients with insulin treated diabetes, who are mildly frail. This study also aims to increase understanding of the impact of resistance training on patients with diabetes psycho-socially. Findings will be used to inform a future trial should the training prove acceptable and feasible.
Who can participate?
Thirty patients with insulin-treated diabetes (type 1 and 2), and thirty without (matched for age and frailty), aged 60 or over, will be recruited.
What does the study involve?
All participants will complete blood and physical testing. Fifteen of each group will then be randomised to a four-week supervised resistance training programme, designed to increase muscle mass/strength. All participants will then repeat the physical testing. A subset will be interviewed before and after the training programme to understand their perceptions of training, and living with diabetes (where relevant) as they have aged.
What are the possible benefits and risks of participating?
There is no direct benefit for participants. However, exercise is repeatedly shown to be of benefit, both physically and mentally.
All participants will be screened before taking part in the study, to ensure that they do not have any conditions which exercise may exacerbate. This is to ensure safety.
The resistance training programme is designed to be accessible to all, building gradually over the four week period. Participants will be fully supervised, and weights will be adjusted to what they can easily lift (rather than a specific kilogram weight).
Blood samples will be taken as part of the study, there is the risk of slight discomfort or bruising. These risks will be minimised by samples being taken by experienced clinical staff.
The study requires frequent visits to the CRF which may cause a time inconvenience for participants. Participants will be reimbursed £50 for taking part in the study as compensation for their time. Transportation will be provided for all visits. Participants' visits will also be scheduled at the convenience of the participant, such that any inconvenience is minimised.
Where is the study run from?
Newcastle University (UK) and the Clinical Research Facility at the Royal Victoria Infirmary, Newcastle-upon-Tyne (UK)
When is the study starting and how long is it expected to run for?
From December 2019 to September 2022
Who is funding the study?
Internal Newcastle University funding supported by the Wellcome Trust small grant scheme (UK)
Who is the main contact?
Dr Daniel West
daniel.west@newcastle.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Daniel West
ORCID ID
Contact details
Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
+44 (0)1912087076
daniel.west@newcastle.ac.uk
Type
Public
Additional contact
Dr Daniel West
ORCID ID
Contact details
Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
+44 (0)1912087076
daniel.west@newcastle.ac.uk
Type
Public
Additional contact
Dr Rachel Stocker
ORCID ID
Contact details
Institute of Cellular Medicine
Room M4.077
William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
+44 (0)1912082057
rachel.stocker@newcastle.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 269661
Study information
Scientific title
EXercise to Prevent frailty and Loss Of independence in insulin treated older people with DiabetEs: The EXPLODE Trial
Acronym
EXPLODE
Study hypothesis
The aim of this trial is to characterise the physical function, cardiovascular health, and the health and wellbeing of older people living with diabetes, and compare that to a matched control group.
Ethics approval
Pending review on 15/07/2020, NHS North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHS BT Blood Donor Centre, Holland Drive, HRA Newcastle, UK, NE2 4NQ; newcastlenorthtyneside2.rec@hra.nhs.uk; +44 (0)207 104 8222). ref: 20/NE/0178
Study design
Single-centre interventional parallel group feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Type 1 diabetes and type 2 diabetes treated with exogenous insulin
Intervention
All participants will complete baseline blood and physical testing. Participants will then be randomised (1:1 ratio) to either:
1. Intervention group, a 4-week programme of supervised resistance exercise training
2. Control group, where participants will be instructed to carry on with any usual activity as normal
Randomisation will be carried out online by a member of the study team, using https://www.sealedenvelope.com
All participants will then repeat the physical testing. A subset will also be interviewed before and after the training programme to understand their perceptions of training, and living with diabetes (where relevant) as they have aged.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility of carrying out a larger trial, measured using recruitment and retention rate, and the acceptability of intervention of resistance exercise as assessed using an interview of a subset of participants at baseline and 5 weeks
Secondary outcome measures
1. Body composition measured using height, weight, waist circumference, percentage body fat, and percentage fat-free mass using bioelectrical impedance analysis at baseline and 5 weeks
2. Isometric strength measured using a torque and strain gauge at baseline and 5 weeks
3. Handgrip strength measured using a digital handgrip dynamometer at baseline and 5 weeks
4. Gait speed measured using three 4 m walking tests on digital timing gates at baseline and 5 weeks
5. Timed sit to stand, measured using five sit to stand movements at baseline and 5 weeks
6. Cardiovascular health measured using resting blood pressure, HbA1c, blood lipid profile, and inflammatory cytokines at baseline and 5 weeks
7. Wellbeing, activity levels, and (where applicable) views on the resistance training programme and diabetes management, measured narratively using a nested qualitative interview study at baseline and 5 weeks
Overall trial start date
01/12/2019
Overall trial end date
30/09/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥60 years
2. Rockwood Clinical Frailty Score of 3 or 4
3. Diagnosis of type 1 or type 2 diabetes mellitus, or age and frailty matched non-diabetic control
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Myocardial infarction in the last 12 months
2. Stroke in the last 12 months
3. Renal failure in the last 12 months
4. Liver disease in the last 12 months
5. Inability to give consent
Recruitment start date
01/10/2020
Recruitment end date
01/04/2022
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Leazes Wing Main Entrance
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle-upon-Tyne
NE3 3HD
United Kingdom
+44 (0)1912824520
nuth.nuthsponsorship@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Faculty of Medical Sciences, Newcastle University
Alternative name(s)
FMS
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal and at scientific conferences
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/09/2023
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list