Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000993493
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
28/07/2016
Date last updated
14/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a foot strengthening exercise program to improve foot function and foot health in older adults with diabetes
Scientific title
Evaluating a foot strengthening exercise program to improve foot function and foot health in older adults with diabetes
Secondary ID [1] 289183 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 298738 0
Peripheral neuropathy 299568 0
Condition category
Condition code
Musculoskeletal 298784 298784 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 299539 299539 0 0
Diabetes
Physical Medicine / Rehabilitation 299540 299540 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention will be enrolled into a supervised exercise program, whereby they will attend a group exercise classes and be lead through the exercises. An Accredited Exercise Physiologist will be employed to conduct the supervised exercise program, and have no involvement with the assessments.
The exercise program consists of a warmup, followed by a series of eight exercises that were developed by the Chief Investigator to strengthen the foot muscles (Short Foot exercise, heel raises, ankle inversion/eversion/dorsiflexion, toe/hallux flexion and big toe pulls). Most exercises will be performed using exercise bands (66fit latex, Physio Supplies, Spalding, UK), with the resistance level starting from light (yellow) and progressing through to xheavy (blue). The level of exercise difficulty is progressively increased throughout the 12 week program, by increasing either the strength of the resistance bands or the number of repetitions. The number of repetitions and resistance is prescribed each week, however, if a participant finds an exercise too difficult the resistance is not increased and attempted at the next session.
All participants will be asked to attend the exercise classes (45 minutes) three times a week, for 12 weeks. Class attendance is recorded by the EP.
Intervention code [1] 294717 0
Rehabilitation
Comparator / control treatment
Maintain regular activities, no exercises given.
Control group
Active

Outcomes
Primary outcome [1] 298259 0
Strength of the hallux (big toe) and lesser toes measured using a pressure platform (%BW)
Timepoint [1] 298259 0
12 weeks
Primary outcome [2] 298260 0
Forefoot plantar pressure will be quantified for each participant during walking while barefoot across an emed pressure platform using the 2 step method.
Timepoint [2] 298260 0
12 weeks
Secondary outcome [1] 323720 0
Ankle strength will be measured (kg) using a hand-held Manual Muscle Tester (Lafayette) while the participant performs inversion, eversion, dorsiflexion and plantar flexion of the ankle.
Timepoint [1] 323720 0
12 weeks
Secondary outcome [2] 323721 0
The Foot Health Status Questionnaire (FHSQ) will measure health-related quality of life with respect to foot health.
Timepoint [2] 323721 0
12 weeks
Secondary outcome [3] 323722 0
Single-leg balance time will be used as a clinical measure of balance. Participants stand with their weight evenly distributed across both feet, with their eyes open and focused on a point on the wall/floor. Keeping their arms by their sides, each participant will be asked to lift the non-test foot off the floor and try to maintain their balance as long as possible. The test (and timer) was stopped after 60 s or when the lifted foot was placed on the floor. Participants will be given two attempts on each leg unless they were able to complete 60 s on their first attempt. If a participant can complete at least 10 s on the eyes-open component, the task progresses to performing the test with their eyes closed.
Timepoint [3] 323722 0
12 weeks
Secondary outcome [4] 323723 0
The foot and lower leg will be scanned using a reliable ultrasound protocol to obtain toe flexor muscle thickness and cross-sectional area.
Timepoint [4] 323723 0
12 weeks

Eligibility
Key inclusion criteria
Type 2 Diabetes; be able to walk for at least 10 m unaided; independantly living, peripheral neuropathy; minimal hearing or vision impairments
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes; Fail the Short Portable Mental Status Questionnaire; foot or toe amputation, severe foot deformity; peripheral arterial disease (ABI <0.9), foot ulceration, planned foot or leg surgery during the intervention period, received any corticosteroid injections to the forefoot within the last 3 months; have an unstable neurological or health condition (e.g Parkinsons, Motor Neuron Disease, cancer), limited English language skills (i.e unable to read consent form); participating in physical therapy interventions of lower limb

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)
After the participants complete the baseline assessment, they will receive an opaque envelope that will reveal their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by an online sequence generator
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
Efficacy
Statistical methods / analysis
Statistical analyses: Data will initially be checked for normality and determine any differences between groups in baseline data. Main comparative analyses between groups will then be performed using a repeated measures analysis of variance. A comparison between pre and post will allow us to determine whether changes in the intervention are greater than the control group.
Scores from the Foot Health Status Questionnaire will not be normally distributed, so the between-group difference will be determined by comparing the change in score between baseline and follow-up using a Kruskal-Wallis test.
Sample size: A total of 64 patients are needed for this two-treatment parallel-design study. The probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 significance level, if the true difference in toe strength between treatments is 1.800 units. This is based on the assumption that the standard deviation of the response variable is 2.5. An additional 18% is required for the intervention group to allow for drop-out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2016
Actual
31/08/2016
Date of last participant enrolment
Anticipated
23/12/2016
Actual
Date of last data collection
Anticipated
31/03/2017
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294032 0
University
Name [1] 294032 0
Victoria University
Country [1] 294032 0
Australia
Primary sponsor type
Individual
Name
Karen Mickle
Address
ISEAL
Victoria University
PO Box 14428
Australia Melbourne,
Victoria 8001
Country
Australia
Secondary sponsor category [1] 292854 0
Individual
Name [1] 292854 0
Rezaul Begg
Address [1] 292854 0
ISEAL
Victoria University
PO Box 14428
Australia Melbourne,
Victoria 8001
Country [1] 292854 0
Australia
Secondary sponsor category [2] 292916 0
Individual
Name [2] 292916 0
Patrick McLaughlin
Address [2] 292916 0
College of Health and Biomedicine
Victoria University
PO Box 14428
Australia Melbourne,
Victoria 8001
Country [2] 292916 0
Australia
Secondary sponsor category [3] 292917 0
Individual
Name [3] 292917 0
Rajna Ogrin
Address [3] 292917 0
Royal District Nursing Service
31 Alma Rd,
St Kilda, VIC 3182
Country [3] 292917 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295510 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 295510 0
Ethics committee country [1] 295510 0
Australia
Date submitted for ethics approval [1] 295510 0
25/11/2015
Approval date [1] 295510 0
19/07/2016
Ethics approval number [1] 295510 0
HRE15-303

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

Contacts
Principal investigator
Name 65770 0
Dr Karen Mickle
Address 65770 0
ISEAL
Victoria University
PO Box 14428
Melbourne
VIC 8001
Country 65770 0
Australia
Phone 65770 0
+61 2 99195611
Fax 65770 0
Email 65770 0
[email protected]
Contact person for public queries
Name 65771 0
Karen Mickle
Address 65771 0
ISEAL
Victoria University
PO Box 14428
Melbourne
VIC 8001
Country 65771 0
Australia
Phone 65771 0
+61 2 99195611
Fax 65771 0
Email 65771 0
[email protected]
Contact person for scientific queries
Name 65772 0
Karen Mickle
Address 65772 0
ISEAL
Victoria University
PO Box 14428
Melbourne
VIC 8001
Country 65772 0
Australia
Phone 65772 0
+61 2 99195611
Fax 65772 0
Email 65772 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
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