Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001715460
Ethics application status
Approved
Date submitted
20/11/2016
Date registered
14/12/2016
Date last updated
14/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a hand strength exercise program improve grip strength in elderly patients with wrist fractures?
Scientific title
Does a hand strength exercise program improve grip strength in elderly patients with wrist fractures treated non-operatively? A Randomized Control Trial
Secondary ID [1] 290583 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
distal radius fracture 301039 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300827 300827 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 301076 301076 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention:

A 4 week schedule of specific hand strength exercises to perform on a daily basis at home between 2 and 6 weeks after injury

Patients will tick off a check sheet regarding adherence to the exercises and this will be collected at the 6 week mark.

The exercises to be performed in the intervention group have been discussed with the supervisor who is a hand surgeon and the physiotherapist. It will consist of 3 categories; Finger range of motion, isometric finger exercises and the use of a squeeze ball given to the patient.

The finger range of motion exercises and isometric finger exercises will be performed in the 1st week with the use of the squeeze ball to be introduced in the 2nd week and consistently used in the 3rd and 4th week.

In the intervention group, the exercises will be explained to the patient at their fracture clinic follow up on recruitment. The surgeon will explain to the participant the exercises in a 1 half hour session. Each exercise is explained to the patient clearly by the surgeon showing the patient with their own hand, and the participant then performing the exercise with their normal hand then their injured hand.

The participant will then receive a 4 week schedule to follow explaining the exercises daily and a checklist to tick off to ensure that the participant is following the exercise program.

If the participant has any questions after the visit during the 4 weeks, they are advised to contact the investigator or the surgeon for further explanation.

There is no specific duration in which the participant must complete the exercises daily. They have a set regime i.e. finger isometric exercises each finger 10 times a day in which is advised to carry out within a day, but not within a time limit of that day.

The intervention group will have a cast. The same as the control group. The short arm fibreglass cast will however have enough room to enable the participant to make a fist, and be able to touch each finger and thumb together, allowing free movement of the thenar eminence.
Intervention code [1] 296447 0
Rehabilitation
Comparator / control treatment
Control:
For all distal radius fractures managed non operatively, they are placed in a short arm full fibreglass cast at 2 weeks for a total of 4 weeks.

During this period they are asked to move their fingers however there are no specific exercises given.

Our control group will be the normal practice at our institution between 2 and 6 weeks after distal radius fracture of asking the patients to move their fingers.
Control group
Active

Outcomes
Primary outcome [1] 300250 0
Grip strength will be measured using a JAMAR hand-grip dynamometer
Timepoint [1] 300250 0
3 months post injury
Secondary outcome [1] 329495 0
QUICK-DASH score
Timepoint [1] 329495 0
3 months post injury
Secondary outcome [2] 329496 0
visual analogue scale - pain
Timepoint [2] 329496 0
3 months post injury
Secondary outcome [3] 329497 0
Complex regional pain syndrome will be assessed using the Budapest Criteria
Timepoint [3] 329497 0
3 months post injury

Eligibility
Key inclusion criteria
distal radius fracture in patients over the age of 60
single sided fracture
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
bilateral distal radius fracture
existing neurological condition which has lead to weakness in the ipsilateral limb
prior distal radius fracture in same arm
prior hand or wrist surgery in same arm
patients with dementia or unable to follow instructions

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation in blocks
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6959 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 14650 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 295170 0
Hospital
Name [1] 295170 0
Concord Hospital
Country [1] 295170 0
Australia
Primary sponsor type
Individual
Name
Dr Jai Sungaran
Address
Concord Hospital
Hospital Road
Concord West NSW 2139
Country
Australia
Secondary sponsor category [1] 293832 0
None
Name [1] 293832 0
NA
Address [1] 293832 0
NA
Country [1] 293832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296367 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 296367 0
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139
Ethics committee country [1] 296367 0
Australia
Date submitted for ethics approval [1] 296367 0
26/11/2015
Approval date [1] 296367 0
15/03/2016
Ethics approval number [1] 296367 0
CH62/6/2015-181

Summary
Brief summary
Wrist fractures are amongst the most common fractures suffered by elderly patients.
There is limited data regarding grip strength of elderly patients who have suffered a distal radius fracture at the 2 and 6 week mark post injury.
We performed a pilot study in the last year investigating grip strength in patients with distal radius fractures at 2 and 6 weeks post injury to determine whether they could drive. One major finding was that patients over the age of 60 who suffered a distal radius fracture had around 0-5kg of grip strength when measured at 2 and 6 weeks post injury.
We also found that most patients were given a physiotherapy handout of range of motion exercises which they could perform. There was no strict guideline or recommendation of how often to perform the exercises and there were no grip strength exercises recommended.
Grip strength in elderly patients has been noted to be a good indicator of function. Maintenance of function in the elderly patient is of great importance to a patient’s independence in mobility and activities of daily living.
We hypothesize that a grip strength focused exercise program given to elderly patients with distal radius fractures will significantly improve patients’ grip strength and therefore function.
This study would be of clinical significance to the elderly patient who suffers a wrist fracture. If we can improve a person’s grip strength and function, we may also improve their quality of life.

Aim/Objective:
To determine whether an exercise program will improve grip strength in elderly patients with distal radius fractures treated nonoperatively.

Secondary objective
1. Determine whether an exercise program will improve pain in elderly patients with distal radius fractures
2. To determine whether an exercise program will improve function and reduce complex regional pain syndrome

Hypothesis
We hypothesize that adherence to a grip strength focused exercise program for a month between 2 weeks and 6 weeks post injury will improve grip strength in elderly patients who suffer a distal radius fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70610 0
Dr Jai Sungaran
Address 70610 0
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139
Country 70610 0
Australia
Phone 70610 0
+61 2 97675000
Fax 70610 0
Email 70610 0
sungaran@optusnet.com.au
Contact person for public queries
Name 70611 0
Dr Antony Nguyen
Address 70611 0
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139
Country 70611 0
Australia
Phone 70611 0
+61 2 97675000
Fax 70611 0
Email 70611 0
antony_nguyen@hotmail.com
Contact person for scientific queries
Name 70612 0
Dr Antony Nguyen
Address 70612 0
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139
Country 70612 0
Australia
Phone 70612 0
+61 2 97675000
Fax 70612 0
Email 70612 0
antony_nguyen@hotmail.com

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

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