Does resistance training exercise help prevent frailty and loss of independence for older people with insulin treated diabetes? The EXPLODE Trial
| ISRCTN | ISRCTN13193281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13193281 |
| IRAS number | 269661 |
| Secondary identifying numbers | IRAS 269661 |
- Submission date
- 15/07/2020
- Registration date
- 03/08/2020
- Last edited
- 16/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 April 2025
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
Contact information
Scientific
Institute of Cellular Medicine
Room M4.077, William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)1912087076 |
|---|---|
| daniel.west@newcastle.ac.uk |
Public
Institute of Cellular Medicine
Room M4.077, William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)1912087076 |
|---|---|
| daniel.west@newcastle.ac.uk |
Public
Institute of Cellular Medicine
Room M4.077, William Leech Building
Newcastle-upon-Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)1912082057 |
|---|---|
| rachel.stocker@newcastle.ac.uk |
Study information
| Study design | Single-centre interventional parallel group feasibility randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | EXercise to Prevent frailty and Loss Of independence in insulin treated older people with DiabetEs: The EXPLODE Trial |
| Study acronym | EXPLODE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2019 |
| Completion date | 01/04/2025 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Level 1, Regent Point
Regent Farm Road
Gosforth
Newcastle-upon-Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912824520 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- FMS
- Location
- United Kingdom
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal and at scientific conferences |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/12/2021 | 10/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2023 to 31/01/2025.
2. The overall end date was changed from 30/04/2023 to 01/04/2025.
3. The plain English summary was updated to reflect these changes.
4. The intention to publish date was changed from 30/09/2023 to 30/09/2026.
04/04/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2022 to 31/01/2023.
2. The overall end date was changed from 30/09/2022 to 30/04/2023.
3. The plain English summary was updated to reflect these changes.
10/12/2021: Publication reference added.
20/07/2020: Trial’s existence confirmed by Newcastle University.
