Regular resistance training in children with type 1 diabetes improves glycaemic control and physical fitness
| ISRCTN | ISRCTN12066515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12066515 |
| Secondary identifying numbers | EK-13-175-0813 |
- Submission date
- 09/08/2018
- Registration date
- 30/08/2018
- Last edited
- 08/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The incidence of insulin-dependent diabetes mellitus (type 1 diabetes) has increased especially in children and adolescents under the age of 15. Exercise has been accepted and generally recommended for the management of type 1 diabetes. Young people generally prefer to use gyms for resistance training; however, there is unfortunately a lack of information on resistance training in children with type 1 diabetes. This study aims to look at the effects of supervised resistance training in children with type 1 diabetes.
Who can participate?
Children aged 8-12 with type 1 diabetes, diagnosed at least 6 months before the study
What does the study involve?
Children participating in this study will be randomised into either the intervention or the control group. Children in the intervention group will participate in a 32 week program of resistance training, with a 50 minute session twice per week. Children in the control group will continue as usual. Both groups will be asked to undertake various measurements at the start and end of the 32 week intervention, including height, weight, exercise and strength tests and blood tests.
What are the possible benefits and risks of participating ?
The possible benefit of participating is that taking part in the exercise intervention should result in an improvement of physical fitness and in control of their diabetes. There are no known risks to participants taking part in this study, other than possible hypoglycaemia. However, blood glucose will be determined before and after each exercise session to monitor this and prevent hypoglycaemia.
Where is the study run from?
Department of Pediatrics, Department of Chemistry and the Institute of Physical Medicine and Rehabilitation at the Danube Hospital Vienna (Austria)
When is the study starting and how long is it expected to run for?
August 2013 to April 2015
Who is funding the study?
City Government of Vienna (Austria)
Who is the main contact?
Prof. Ramon Baron
ramon.baron@univie.ac.at
Contact information
Scientific
Auf der Schmelz 6
Vienna
1150
Austria
 ORCID ID |
0000-0001-5774-5482 |
|---|
Study information
| Study design | Interventional single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | The effect of a 32 weeks intervention period of supervised progressive resistance training on glycaemic control, physical fitness and adiponectin in children with type 1 diabetes |
| Study acronym | N/A |
| Study hypothesis | We hypothesized, that similar to endurance training, regular progressive resistance training in children with type 1 diabetes improves HbA1c levels and physical fitness. Additionally, we hypothesized that progressive resistance has a positive effect on adiponectin levels. |
| Ethics approval(s) | Ethics board of the City Goverment of Vienna, 08/10/2013, EK 13- 175-0813 |
| Condition | Type 1 diabetes mellitus |
| Intervention | Participants were randomised using simple randomisation with Excel into 2 groups, an intervention group and a control group. At the beginning of the study, participants in both groups performed a standardised, self-paced 6-minute walk test (6MWT) in a corridor of 30 m in length. Strength was assessed using 3 common multi-joint exercises (seated bench press, seated bench pull and a seated leg press). Blood samples were then collected from all participants in the morning after fasting. Echocardiograms were performed to investigate the left common carotid artery. Participants in the intervention group performed progressive resistance training twice a week for 32 weeks. This involved a circuit exercise programme with 8 stations. Each session lasted for 50 minutes, comprising a 10 minute warm-up, 20-40 minutes of circuit training and cool-down routine for the remainder of the time. Work time was increased and rest time was decreased according to the training load progression principle. The control group received no intervention and continued their normal daily activities. At the end of the intervention, the same tests and examinations as at the start of the study were performed for both groups. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The following were assessed at the baseline and at the end of the intervention (32 weeks): 1. HbA1C levels, assessed through analysis of venous blood samples 2. Physical fitness, assessed using: 2.1. 6-minute walking/running test (GMWT) in a corridor of 30 metres in length 2.2. Strength test including a seated bench press, seated bench pull and seated leg press, assessed using a dynamometer |
| Secondary outcome measures | The following were assessed at the baseline and at the end of the intervention (32 weeks): 1. Adiponectin levels, assessed through ELISA analysis of blood samples 2. Intima-media thickness (IMT - defined as the distance between the leading edges of the lumen-intima interface and the media-adventitia interface of the far wall), assessed through a scan of the left common carotid artery |
| Overall study start date | 28/08/2013 |
| Overall study end date | 28/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 29 |
| Participant inclusion criteria | 1. Type 1 diabetes for at least 6 months 2. No contraindications for participation in a physical activity programme 3. Mixed split-dose insulin regimen 4. No current or recent illness 5. No current or recent operation or injury 6. No participation in regular sport 7. Sports lessons in school less frequently than twice a week |
| Participant exclusion criteria | N/A |
| Recruitment start date | 30/06/2014 |
| Recruitment end date | 22/08/2014 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1220
Austria
Sponsor information
Government
Thomas Klestil Platz 8
Vienna
1030
Austria
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish in the Journal of Diabetes Care as soon as possible. |
| IPD sharing plan | Data will be shared in tabular form. All participants were informed comprehensively about purpose, procedures, benefits, risks and discomfort that might result from study participation, as well as the right to terminate participation at will, before they gave written consent to participate in the study. A letter of agreement had to be signed by the participant’s parents or guardians and all participants took part voluntarily. The parents also agreed that the results could be published in anonymous form. Participants were identified by a number code. The number code was known only to the head of the study. |
Editorial Notes
08/11/2019: Internal review.
10/06/2019: The intention to publish date was updated from 31/12/2018 to 31/12/2019.
