Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Aarhus
About this trial
The goal of this clinical trial is to find out whether a therapist-guided exercise program helps people aged 50 and older recover better, in terms of pain and function, after a wrist fracture, compared to the usual care advice they would normally receive. The main question it aims to answer is:
• Will participants who receive a therapist-supervised exercise program have better improvement in pain and function, as measured by the Patient Rated Wrist Evaluation questionnaire, six months after their injury?
Researchers will compare these participants with those who receive usual care, which includes advice on self-management, to see if the supervised exercise program leads to greater recovery.
Participants will:
* Either receive supervised exercise, with a therapy session of up to 60 minutes and two additional sessions of up to 30 minutes each in addition to usual-care, or they will receive solely usual-care, consisting of advice on self-management. * Complete questionnaires electronically at baseline, 3-months, and 6-months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Distal radius fracture treated surgically or non-surgically
Willing and able to give informed consent
Disqualifiers
Injury is more than two months old
There is evidence that the patient would be unable to participate in therapy or a self-guided exercise program provided by a participating center or adhere to study procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome)
No e-mail address to receive electronic questionnaires
Open fractures with a Gustilo & Anderson grading >1
Trial design
Design model
Parallel
Treatments tested in this trial
Supervised Exercise
Other interventionVerbal advice, a leaflet, and instruction in a strength training program delivered by an occupational or physical therapist at the hospital or virtually. This is followed by two additional sessions with a therapist in the municipality, focusing on progression in the exercise program. Participants will receive written instructions (a Supervised Exercise workbook) along with a personal login to access a patient information video. The exercise program is a highly structured system of hand and upper limb exercises. The program will enable participants to progress their exercises after the initial set-up session with the therapist. The program will utilize a range of resistance exercises based upon functional movements designed to promote recovery of the strength required for activities of daily living (e.g., chopping, lifting, pushing, jar opening).
Usual Care
Other interventionVerbal advice and a leaflet provided at the hospital. Advice will include hand and wrist mobilization exercises to restore flexibility and guidance on building up activity gradually. Participants receiving solely usual care will not be provided with access to the intervention materials (the Supervised Exercise workbook).
Treatment groups
588 Participants
are divided into 2 treatment groupsGroup A: Supervised Exercise in addition to Usual Care (intervention)Experimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-Rated Wrist Evaluation (PRWE)
The primary outcome is the Patient Rated Wrist Evaluation (PRWE) at 6 months post-randomization: A 15 item patient-reported questionnaire that assesses pain and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area (total score ranges from 0 to 100, higher scores indicate worse wrist pain and function). The pain subscale has 5 items (0 = no pain, 10 = worst pain) and the function subscale has 10 items (0 = no difficulty, 10 = unable to do). A total score on a scale of 100 is computed from the two subscales equally weighted (0 = no disability). The total score is the trial primary outcome, with the two subscales also reported as secondary outcomes.
Time frame
Measured at baseline, 3 months and 6 months follow-upSecondary outcomes
1
Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE)
The PRWE pain subscale contains 5 items each of which is further rated from 0-10 (0 = no pain, 10 = worst pain). The maximum score in this section is 50 and minimum 0.
Time frame
Baseline, 3 months and 6 months follow-up2
Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE)
The PRWE function subscale contains 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items) and is rated from 0-10 (0 = no difficulty, 10 = unable to do). The score of all 10 items is summed and then divided by 2, resulting in a maximum score of 50 and minimum 0.
Time frame
Baseline, 3 months and 6 months follow-up3
PROMIS Physical Function Upper Extremity-Short Form 7a
Self-reported capability focusing on activities that require use of the upper extremity including shoulder, arm, and hand activities. The PROMIS Physical Function Upper Extremity-Short Form 7a contains 7 questions scored 1-5, with 1 being unable to do the activity and 5 being able to do the activity without any difficulty.
Time frame
Baseline, 3 months and 6 months follow-up4
QuickDASH
The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). A higher score indicates greater disability.
Time frame
Baseline, 3 months and 6 months follow-upOther outcomes
1
Health resource use
Health resource use as measured by self-reported bespoke questionnaire (including primary and secondary care consultation, additional therapy, investigations, surgery, prescribed and over-the-counter pain medication), sick leave (days), out-of-pocket expenses. Resource use will be converted into costs using standard unit cost estimates. The components will be aggregated to estimate the total cost per participant.
Time frame
3 months and 6 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital Skejby
Collaborator
Source ClinicalTrials.gov