Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/08/2018
Date assigned
30/08/2018
Last edited
08/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ramon Baron

ORCID ID

http://orcid.org/0000-0001-5774-5482

Contact details

Auf der Schmelz 6
Vienna
1150
Austria

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EK-13-175-0813

Study information

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

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

Ethics board of the City Goverment of Vienna, 08/10/2013, EK 13- 175-0813

Study design

Interventional single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 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

Phase

Drug names

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 trial start date

28/08/2013

Overall trial end date

28/04/2015

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

29

Participant exclusion criteria

N/A

Recruitment start date

30/06/2014

Recruitment end date

22/08/2014

Locations

Countries of recruitment

Austria

Trial participating centre

Only one centre Danube Hospital
Langobardenstrasse 122
Vienna
1220
Austria

Sponsor information

Organisation

Medical scientific fund of the city of vienna- ethics committee of the city of vienna

Sponsor details

Thomas Klestil Platz 8
Vienna
1030
Austria

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

This project was supported, in part, by grants from the City Government of Vienna.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish in the Journal of Diabetes Care as soon as possible.

IPD sharing statement:
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.

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

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.