Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000728033
Ethics application status
Approved
Date submitted
27/08/2010
Date registered
1/09/2010
Date last updated
1/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Personal Trainer Assisted Strength Training Programme for Pacific Adults with Diabetes – A feasibility study
Scientific title
A prospective, randomised controlled, open two-group, one-year feasibility trial to evaluate the effect of a personal trainer facilitated individually tailored gym based structured resistance exercise programme on insulin sensitivity in Pacific adults diagnosed with type 2 diabetes mellitus, when compared to usual care
Secondary ID [1] 252584 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To explore the impact of a personal trainer in increasing adherence rates for Pacific adults with diabetes participating in an individually tailored gym based structured resistance exercise programme 258096 0
To determine the impact of an individually tailored gym based structured resistance exercise programme on insulin sensitivity for Pacific adults with diabetes 258102 0
Condition category
Condition code
Musculoskeletal 258249 258249 0 0
Normal musculoskeletal and cartilage development and function
Metabolic and Endocrine 258250 258250 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include three sessions per week for 30 minutes per session. Participants will be part of a group of two or three, working with one personal trainer in each session. All sessions will be supervised by the personal trainer to ensure correct technique and to monitor the appropriate amount of exercise and rest intervals. The resistance programme will be periodised to allow progressive increases in the resistance training programme based on the individual’s ability and adaptation to the resistance training intervention. The 30 minutes sessions will begin with 5 minutes warm up on a stationary bicycle or walking on a treadmill. This will be followed by 20 minutes of high intensity resistance training using body weight exercises, strength machines and free weight exercises. The 30 minute sessions will conclude with 5 minutes warm down on a stationary cycle. When an individual shows they can easily complete a strength exercise with appropriate technique, they will progress on to a more challenging weight or exercise. The specific resistance exercises chosen for each individual will be introduced dependant on the individual’s personal ability and experience. The workout will also be varied at each session by the personal trainer dependant on the individual’s energy levels, muscle soreness and performance at the specific session. The sessions will be offered at a variety of times across the full seven day week to ensure that there are times which are suitable for the participants.
The personal trainer facilitated sessions will cease following 12 weeks, though membership at the gym will continue for a further 12 weeks, to allow the non-coached attendance rates to be monitored.
Intervention code [1] 257106 0
Lifestyle
Intervention code [2] 257123 0
Treatment: Other
Comparator / control treatment
At three months, the control group will commence attendance at a gym, which will be subsidised for three months
Control group
Active

Outcomes
Primary outcome [1] 259095 0
Glycated Haemoglobin (HBA1c) levels assessed through plasma HBA1c assay
Timepoint [1] 259095 0
0, 3 and 6 months
Primary outcome [2] 259116 0
Adherence - attendance rates for the intervention group will be recorded though direct report from the gyms/personal trainers as well as self-report activity diaries and a membership card swipe system.
Timepoint [2] 259116 0
0, 3 and 6 months
Secondary outcome [1] 265428 0
Safety measures at all sessions, pain will be assessed verbally and on a weekly basis, pain experienced (muscle, joint, other) will be assessed by a short-form of the McGill Pain questionnaire (SF-MPQ). In addition, fatigue experienced will be assessed with BORG rating of perceived exertion (RPE)
Timepoint [1] 265428 0
0, 3 and 6 months

Eligibility
Key inclusion criteria
Individuals are potentially eligible if they meet all of the following criteria: (i) Pacific adults aged 18+; (ii) have been diagnosed with type 2 diabetes Mellitus who are not receiving insulin injections; (iii) Can easily access the Mount Wellington region and; (iv) can provide written informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have been diagnosed with Type 2 Diabetes Mellitus and are receiving insulin injections;

Live outside of the Mount Wellington region and;

Are unable to provide written informed consent to participate in the study.

The General Practitioner considers a participant unsuitable to enrol as they are assessed as having impaired cognition, severe heart or respiratory disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2840 0
New Zealand
State/province [1] 2840 0

Funding & Sponsors
Funding source category [1] 257553 0
University
Name [1] 257553 0
Strategy To Advance Research (STAR) Project
Country [1] 257553 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 256774 0
None
Name [1] 256774 0
Address [1] 256774 0
Country [1] 256774 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31581 0
Address 31581 0
Country 31581 0
Phone 31581 0
Fax 31581 0
Email 31581 0
Contact person for public queries
Name 14828 0
A/Prof. Matthew Parsons
Address 14828 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
1142
Country 14828 0
New Zealand
Phone 14828 0
+64 9 373 7599
Fax 14828 0
Email 14828 0
m.parsons@auckland.ac.nz
Contact person for scientific queries
Name 5756 0
A/Prof. Matthew Parsons
Address 5756 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
1142
Country 5756 0
New Zealand
Phone 5756 0
+64 9 373 7599
Fax 5756 0
Email 5756 0
m.parsons@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.