Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/07/2020
Date assigned
03/08/2020
Last edited
27/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

University/education

Funder name

Faculty of Medical Sciences, Newcastle University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

unknown

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

20/07/2020: Trial’s existence confirmed by Newcastle University.