Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/01/2017
Date assigned
30/01/2017
Last edited
30/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where sufferers have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). In recent years, many studies have shown that regular physical activity and exercise can help to control the disease. However, encouraging patients to keep up with exercise programs in their own time can be difficult. Walking and step training are forms of exercise that can be carried out in any location. This allows individuals to incorporate short bouts of exercise, which have previously been shown to be beneficial in both diabetic and non-diabetic individuals, into their daily routines. This study is looking at a new exercise prescription in complication with a mobile phone application designed specifically for this study that helps to monitor the physical activity of participants, tailor their daily individual prescription based on their successful or not completion of previous exercise sessions and provide them with further encouragement. The aim of this study is to find out whether this program can help patients to keep exercising on their own to help control their diabetes.

Who can participate?
Inactive adults aged between 40 and 65 who have T2DM that is not treated with insulin.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are given an outline for an exercise program that they are asked to incorporate into their routines over a period of 16 weeks. The program gradually increases the length and frequency of exercise sessions over the course of the 16 weeks. Those in the second group take part in the same exercise program as the first group in addition to being able to download a mobile phone app which automatically provides reminders and encouragement to complete the prescribed exercise sessions and outline the next exercise session to be completed and record the completion rates of exercise sessions. Participants are asked to input into the app how strenuous they feel each exercise session is. Those in the third group continue with their normal lifestyles for the 16 weeks of the study. At the start of the study and again after 16 weeks, participants have their physical activity levels and weight assessed as well as providing blood samples to test fat levels and blood sugar levels.

What are the possible benefits and risks of participating?
There are no guaranteed benefits of participating however exercising can lead to general health benefits. Risks not provided at time of registration.

Where is the study run from?
University College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
October 2016 to December 2018

Who is funding the study?
Science Foundation Ireland (Ireland)

Who is the main contact?
Mr Hugh Byrne

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hugh Byrne

ORCID ID

Contact details

Insight Centre for Data Analytics
O'Brien Centre for Science
University College Dublin
Belfield
Dublin
Dublin 4
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HBGDVUCDT2DMRCT

Study information

Scientific title

The effects of a novel prescription of multiple short bout of self-directed walking and/or step training combined with a mobile phone based adaptive coaching system in type 2 diabetes mellitus

Acronym

Study hypothesis

The novel exercise prescriptions will increase adherence to exercise and the adherence will be further increased when used in conjunction with the adaptive coaching system.

Ethics approval

UCD Human Research Ethics Committee - Sciences (HREC-LS), 06/10/2016

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes mellitus

Intervention

Participants will be randomly allocated to one of three groups,.

Exercise only group: Participants will be given an outline of the exercise programme that will gradually increase in length and frequency of exercise sessions and are asked to incorporate it into their routines over 16 weeks. The exercise intervention is made up of a 16-week long programme consisting of short bouts of walking and or/step training spread throughout the day where the participants can decide when and where to conduct the individual short bouts of exercise and to choose if they conduct walking or step training at each session. The prescription given to the exercise alone group is progressive in nature and begins with 2 sessions of 2 minutes length on 3 days at 12/20 on Borg RPE scale in week one and gradually progresses in session length, duration, frequency and intensity to 3 sessions of 12 minutes length on 7 days at 16/20 on Borg scale in week 16.

Exercise with coaching app group: Participants will be given an outline of the exercise programme that will gradually increase in length and frequency of exercise sessions and are asked to incorporate it into their routines over 16 weeks. They will also download the mobile phone app which automatically provides reminders and encouragement to complete the prescribed exercise sessions and outline the next exercise session to be completed and record the completion rates of exercise sessions. Participants will be asked to input how strenuous they felt each exercise session was.

Control group: Participants will continue their normal routines for the duration of the study.

Participants are followed up at 16 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Adherence to the exercise prescription is assessed using logbooks in the exercise alone group and using logbooks and self reported adherence in the mobile phone application in the exercise and coaching app group at 16 weeks (exercise groups only)
2. Physical activity levels are measured using the Active Australia Survey at baseline and 16 weeks

Secondary outcome measures

1. Weight is measured using a weighing scales at baseline and 16 weeks
2. BMI is calculated using height and weight measurements taken at baseline and 16 weeks
3. Blood pressure is measured using a sphygmomanometer at baseline and 16 weeks
4. Neuromuscular function using electromyography (EMG) during isometric and isokinetic dynamometry at different speeds at baseline and 16 weeks
5. Functional fitness is measured using the 6 minute walk test at baseline and 16 weeks
6. Grip strength is measured using a hand grip dynamometer at baseline and 16 weeks
7. Lipid profile is measured using blood testing at baseline and 16 weeks
8. Glycated haemoglobin is measured using blood samples collected at baseline and 16 weeks

Overall trial start date

06/10/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of T2DM > 6 months
2. Sedentary – not currently participating in any physical activity (in line with results of the Active Australia Survey)
3. Treated with oral hypoglycaemic agents and diet alone and not with insulin
4. Aged 40-65 years
5. Male and Female
6. Hba1c 7-10%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. Any mental, neurological, cardiovascular, musculoskeletal or orthopaedic deficiency contra-indicating regular training and/or muscular testing or making it impossible or preventing knowing consent to the study
2. Infectious or inflammatory evolving affection
3. Evidence of chronic renal failure or liver disease
4. Severe proliferative diabetic retinopathy
5. Currently or recently pregnant

Recruitment start date

01/12/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Stillorgan Road Belfield
Dublin
Dublin 4
Ireland

Sponsor information

Organisation

University College Dublin

Sponsor details

School of Public Health Physiotherapy & Sports Science and Insight Centre for Data Analytics
Belfield
Dublin
Dublin 4
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Science Foundation Ireland

Alternative name(s)

SFI

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publications in peer reviewed journals.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

28/02/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes