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

• Register: ISRCTN
• Last refreshed on: 5 November 2018
• Main ID: ISRCTN15329422
• Date of registration: 30/01/2017
• Prospective Registration: No
• Primary sponsor: University College Dublin
• Public title: The effects of self-directed walking and/or step training combined with a mobile phone based adaptive coaching system in type 2 diabetes mellitus
• 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
• Date of first enrolment: 01/12/2016
• Target sample size: 75
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15329422
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)

Countries of recruitment

Ireland

Contacts

• Name: Hugh Byrne

Key inclusion & exclusion criteria

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%
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus

Intervention(s)

Interventions as of 11/10/2018:
Some changes were made to the study, largely to do with challenges in recruitment. The methods for the study, in the preliminary version of the journal article, are below.
A summary of the main changes:

2 populations were included, type 2 diabetics and sedentary middle aged individuals.

There was no non-intervention control group but rather the groups had a run-in period and acted as controls for one another.

T2DM patients were recruited through 3 diabetes outpatient clinics in one public and one private hospital. Non T2DM individuals were recruited via emails sent to university staff and alumni and through word of mouth. Participants were not engaged in regular or formal physical activity and were between 30 and 65 (Non T2DM) or 40 and 65 (T2DM) years of age. Written consent was given by the university ethics committee and by the ethics committees of the 2 hospitals.

Individuals with any mental, neurological, cardiovascular, musculoskeletal or orthopaedic deficiency contra-indicating training and/or muscular testing or making it impossible or preventing knowing consent to the study were not included. Individuals with current infectious or inflammatory condition, evidence of chronic renal failure or liver disease, severe proliferative diabetic retinopathy, current or recent pregnancy were also excluded. T2DM participants were not treated with insulin and had a HbA1c of between 53-86mmol/mol and the non T2DM participants also had no other chronic illness or disorder.

In total there were 4 intervention groups and for both population groups there were 2 interventions to which to which participants were randomised. The 2 sets of interventions were identical for both so that there was one intervention group from each population conducting the same intervention as a group from the other population. For both interventions, the exercise protocol was similar and was designed using recent literature with the aim of yielding a high complian

Primary Outcome(s)

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(s)

Secondary outcome measures as of 09/10/2018:
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. Neuromuscular function using electromyography (EMG) during isometric and isokinetic dynamometry at different speeds at baseline and 16 weeks
4. Functional fitness is measured using the 6 minute walk test at baseline and 16 weeks
5. Grip strength is measured using a hand grip dynamometer at baseline and 16 weeks
6. Lipid profile is measured using blood testing at baseline and 16 weeks
7. Glycated haemoglobin is measured using blood samples collected at baseline and 16 weeks

Exit interviews were conducted to allow for qualitative analysis of the interventions.

Previous 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

Secondary ID(s)

HBGDVUCDT2DMRCT

Source(s) of Monetary Support

Science Foundation Ireland

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/12/2018