Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000264280
Ethics application status
Approved
Date submitted
13/03/2009
Date registered
14/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a combined aerobic and resistance exercise program on people with Type 2 diabetes and peripheral neuropathy
Scientific title
The effect of a combined aerobic and resistance exercise program on strength, function and proprioception in people with diabetic peripheral neuropathy
Secondary ID [1] 814 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 4368 0
Peripheral Neuropathy 4369 0
Condition category
Condition code
Metabolic and Endocrine 4614 4614 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12-week combined aerobic and resistance exercise program. This will require participants to attend the Health and Fitness Exercise Clinic at the School of Health Sciences at the University of South Australia twice weekly to perform a combination of aerobic and resistance activities at a moderate intensity. All programs will be individually designed and monitored, and supervised by an accredited exercise physiologist. Each session will be 1 hour in duration. During each session participants will be required to perform 20minutes of moderate intensity low weight bearing exercise such as stationary cycling and rowing. Participants will also be required to perform a progressive resistance training program ranging from 50-85% 1RM (repetition maximum). A combination of 8 exercises will be performed for 8-10 repetitions over 2 sets. The exercises will include a bench press, leg extension, leg curl, calf raise, biceps curl, triceps extension, lateral pull-down and a shoulder press.
Intervention code [1] 4100 0
Lifestyle
Intervention code [2] 4101 0
Behaviour
Comparator / control treatment
no treatment. The control group will be measured every 4 weeks throught the 12 week intervention as well as 4 weeks prior and 4 weeks post intervention.
Control group
Active

Outcomes
Primary outcome [1] 5484 0
Proprioception as measured by plantar sensation using a Semmes Weinstein Monofilament
Timepoint [1] 5484 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention.
Primary outcome [2] 5486 0
Proprioception measured by Vibration Perception Theshold (VPT) using a Biothesiometer
Timepoint [2] 5486 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention.
Primary outcome [3] 5824 0
Proprioception measured by Joint Position Sense (JPS) using an electrogoniometer
Timepoint [3] 5824 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention.
Secondary outcome [1] 9241 0
Quality of Life as measured using the neuropathic specific quality of life tool, NeuroQol.
Timepoint [1] 9241 0
Measured at weeks 0 and 12 of the 12 week intervention, as well as 4 weeks prior and 4 weeks post intervention.
Secondary outcome [2] 9248 0
Short term glycemic control as measured using a blood glucose monitor.
Timepoint [2] 9248 0
Measured immediately before and after each individual exercise session.
Secondary outcome [3] 9249 0
Long term glycemic control (HbA1c, glycosylated hemoglobin) as measured by each participant's general practitioner.
Timepoint [3] 9249 0
Measured at weeks 0 and 12 of the intervention.
Secondary outcome [4] 241826 0
Muscle strength (isokinetic peak torque) measured using a KinCom Dynamometer
Timepoint [4] 241826 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention
Secondary outcome [5] 241827 0
Physical Function as measured by the modified Physical Performance Test (PPT)
Timepoint [5] 241827 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention
Secondary outcome [6] 241828 0
Centre of Pressure during balance measured using a Kistler Force Platform
Timepoint [6] 241828 0
Measured every 4 weeks throughout the intervention as well as 4 weeks prior and 4 weeks post intervention

Eligibility
Key inclusion criteria
participants will be required to obtain a medical clearance from their General Practitioner prior to the commencement of the study. Participants will be aged between 50-70 years, have had Type 2 diabetes for greater than 6 months controlled by diet and/or hypoglycaemic agents, have peripheral neuropathy as diagnosed by their medical officer, and must be sedentary.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
participants will be excluded if they have Type 1 diabetes or Type 2 diabetes controlled by insulin, a history of recurrent hypoglycaemic episodes within the part 6-months, the presence of any co-morbidities which would inhibit physical activity, and the presence or history of any ulceration, amputation or gangrene.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4661 0
University
Name [1] 4661 0
University of South Australia
Country [1] 4661 0
Australia
Primary sponsor type
Individual
Name
Rebecca Nolan
Address
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 4206 0
Individual
Name [1] 4206 0
Professor Esther May
Address [1] 4206 0
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide, SA 5001
Country [1] 4206 0
Australia
Secondary sponsor category [2] 4207 0
Individual
Name [2] 4207 0
Associate Professor Annette Raynor
Address [2] 4207 0
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide, SA 5001
Country [2] 4207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6696 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 6696 0
Ethics committee country [1] 6696 0
Australia
Date submitted for ethics approval [1] 6696 0
Approval date [1] 6696 0
11/03/2009
Ethics approval number [1] 6696 0
P 018/09

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

Contacts
Principal investigator
Name 29313 0
Address 29313 0
Country 29313 0
Phone 29313 0
Fax 29313 0
Email 29313 0
Contact person for public queries
Name 12560 0
Rebecca Nolan
Address 12560 0
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide SA 5001
Country 12560 0
Australia
Phone 12560 0
+61 8 8302 1373
Fax 12560 0
Email 12560 0
[email protected]
Contact person for scientific queries
Name 3488 0
Rebecca Nolan
Address 3488 0
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide SA 5001
Country 3488 0
Australia
Phone 3488 0
+61 8 8302 1373
Fax 3488 0
Email 3488 0
[email protected]

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.