Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000048684
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
17/01/2014
Date last updated
17/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise on peripheral neuropathy in people with diabetes
Scientific title
The effect of exercise on peripheral neuropathy signs and symptoms in people with diabetes
Secondary ID [1] 283546 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 290456 0
Peripheral neuropathy 290457 0
Condition category
Condition code
Metabolic and Endocrine 290846 290846 0 0
Diabetes
Neurological 290847 290847 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 290848 290848 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise
The 8- week exercise program will be performed three times per week and has both aerobic and strengthening components and is based on American Diabetes Association and American College of Sports Medicine recommendations and informed by guidelines for the Medicare funded Type 2 Diabetes Allied Health Group Program.

The program will be individually prescribed and undertaken in a group environment of no more than eight participants. All exercise sessions will be preceded by warm-up and stretching. The aerobic component will progress from 10 min at 50% heart rate reserve to 50 min at 70% heart rate reserve. The strengthening component will begin at 2 sets of 10 repetitions for each exercise gradually progressing to 3 sets of 15 repetitions to maintain rating of perceived exertion in a moderate range (7–8 out of 10). The exercise intervention will be supervised by an Accredited Exercise Physiologist and the program of exercise will be approved by the participant’s General Practitioner.
Intervention code [1] 288242 0
Rehabilitation
Intervention code [2] 288243 0
Behaviour
Comparator / control treatment
Education
The primary aim of the study is to determine the effect of exercise on peripheral neuropathy. To do this a comparative group that does not undertake the exercise is required. As it is expected that exercise will be beneficial for the participants undertaking exercise in exercise-related aspects such as physical capacity, it is ethically important to ensure that participants allocated to the comparative group are not significantly disadvantaged.

It has been demonstrated that group education that incorporates various key aspects of living with type 2 diabetes has a positive effective for diabetes-related health outcomes. Therefore the comparative group will be offered a group education program underpinned by the “Diabetes Conversations” program, which was developed by the International Diabetes Federation based on international guidelines. The interactive group-based program will focus on key areas of living with diabetes and includes:
i. Introduction and goal setting (week 1)
ii. Living with diabetes (week 2)
iii. How diabetes works (week 3)
iv. Healthy eating and staying active (week 4)
v. Dietitian session (week 5)
vi. Exercise physiology session (weeks 6)
vii. Medications (week 7)
viii. Summary and over view (week 8)

The duration of the weekly sessions will be 1 hour and will be administered by a diabetes educator (weeks 1-4, 7-8), dietitian (week 5) and exercise physiologist (week 6).
Control group
Active

Outcomes
Primary outcome [1] 290844 0
Michigan Neuropathy Screening Instrument (symptom score).
Timepoint [1] 290844 0
Measured pre exercise/education program commencement.
Measured post exercise/education program (after 8 weeks of exercise).
Secondary outcome [1] 305425 0
There are three separate physical function secondary outcome measures that explore aerobic fitnes, lower limb endurance and balance.

Aerobic fitness:

Progressive submaximal cycle test
Timepoint [1] 305425 0
Measured pre exercice/education program.
Measured post exercsie/education program (8 weeks)
Secondary outcome [2] 306400 0
Lower limb endurance:

30sec sit-to-stand test
Timepoint [2] 306400 0
Measured pre exercice/education program.
Measured post exercsie/education program (8 weeks)
Secondary outcome [3] 306401 0
Balance:

Tandem stance
Timepoint [3] 306401 0
Measured pre exercice/education program.
Measured post exercsie/education program (8 weeks)

Eligibility
Key inclusion criteria
Age greater than 18 years
Clinical diagnosis of Type 1 or Type 2 diabetes confirmed by General Practitioner
Michigan Neuropathy Screening Instrument score of >2 (examination component) and;
Approval from General Practitioner to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An inability to understand instructions
Serious cardiac pathology
Musculoskeletal problems that would seriously limit exercise
Open wounds on the weight-bearing surface of the feet
Inability to ambulate independently
Stroke or central nervous system pathology
Stage 2 hypertension (resting blood pressure: systolic >160 mmHg or diastolic >100 mmHg).

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)
Participants will be randomised to receive an exercise intervention or an education program. Allocation to either the exercise or education groups will be achieved using a centrally-based computer generated random number sequence. The allocation sequence will be generated and held by an external person off-site not directly involved in the trial. The allocation sequence will be concealed from the researchers assessors of the primary outcome measure of the study. The researcher measuring the secondary outcomes and delivering the exercise intervention will not be blinded to allocation. Due to the nature of the activity of the groups (group exercise or group education) it is not possible to blind the participants to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary statistical analysis for this study is based upon the following parameters:
i. One continuous dependent variable
a. MNSI symptom score
i. Mean total score /15
ii. Two categorical independent variables
a. Intervention
i. Exercise/education
b. Time
i. Baseline/post program

A mixed ANOVA analysis will be undertaken to test whether there are main effects for each of the independent variables and whether the interaction between the two variables are significant. This analysis will inform on whether there is a change in MNSI scores over the two time periods and will compare the two intervention groups in terms of their effectiveness in reducing MNSI scores (improving the symptoms of neuropathy). Finally, this analysis will inform on whether any change in MNSI scores over time is different for the two groups.

There has been only one previous study that has investigated the effect of exercise on peripheral neuropathy. This uncontrolled within-group study demonstrated a large effect for the analysis undertaken (paired t-test, Cohen’s d = 0.7, p = 0.01). In this pilot randomised controlled trial, we seek to determine the effect of exercise on peripheral neuropathy in a controlled, between-groups analysis to inform future research on the clinical significance of exercise on peripheral neuropathy. As such, for the mixed model ANOVA to be undertaken, we have estimated a sample size of 44 to detect a medium of f = 0.20 (power = 80%, p = 0.05). Taking into consideration a 10% drop out rate the sample size required is 48.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288521 0
University
Name [1] 288521 0
La Trobe University
Sport, Exercise and Rehabilitation Research Focus Area
Country [1] 288521 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora
Victoria
3086
Country
Australia
Secondary sponsor category [1] 287231 0
None
Name [1] 287231 0
Address [1] 287231 0
Country [1] 287231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290384 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 290384 0
La Trobe University
Kingsbury Drive
Bundoora
Victoria
3086
Ethics committee country [1] 290384 0
Australia
Date submitted for ethics approval [1] 290384 0
Approval date [1] 290384 0
28/10/2013
Ethics approval number [1] 290384 0
HEC 13-042

Summary
Brief summary
Diabetic neuropathy is a common co-morbidity of diabetes that is a risk factor for foot ulceration and lower limb amputation. Exercise interventions may have the potential to reduce the burden of diabetic foot problems as a recent study demonstrated improvement in peripheral neuropathy symptoms after a structured exercise program in laboratory conditions. Exploration of these promising results in a pragmatic environment is required to understand the true effect of exercise in the management of peripheral neuropathy.

Therefore, we will attempt to answer the following research question: Does structured exercise training improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy?

To answer this question, a pilot randomised controlled trial will be conducted. People with diabetes and peripheral neuropathy will be recruited. Following preliminary testing and randomisation, participants will attend three supervised exercise sessions per week or a diabetes lifestyle coaching program for 8-weeks. Repeat testing will be completed after the completion of the exercise or education program. The primary outcome will be the validated Michigan Neuropathy Screening Instrument score and secondary outcomes will include three separate physical function tests that explore aerobic fitness, lower limb endurance and balance. Based on neuropathy-related effect found in the previous study, approximately 24 participants in each group are required to identify a medium effect (power = 80%, p = 0.05).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44158 0
Mr Byron Perrin
Address 44158 0
La Trobe Rural Health School
PO Box 199
Bendigo
Victoria
3552
Country 44158 0
Australia
Phone 44158 0
61 3 5448 9118
Fax 44158 0
Email 44158 0
[email protected]
Contact person for public queries
Name 44159 0
Mr Byron Perrin
Address 44159 0
La Trobe Rural Health School
PO Box 199
Bendigo
Victoria
3552
Country 44159 0
Australia
Phone 44159 0
61 3 5448 9118
Fax 44159 0
Email 44159 0
[email protected]
Contact person for scientific queries
Name 44160 0
Mr Byron Perrin
Address 44160 0
La Trobe Rural Health School
PO Box 199
Bendigo
Victoria
3552
Country 44160 0
Australia
Phone 44160 0
61 3 5448 9118
Fax 44160 0
Email 44160 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.