Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function (WISE-DK)

Progressive Resistance and Flexibility Exercises Versus Usual Care Advice for Improving Pain and Function After Distal Radius Fracture in Adults Aged 50 Years or Over in Denmark: the WISE-DK Randomised 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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture; Wrist Fracture; Wrist Fractures; Colles Fracture; Fracture Arm
• Intervention / Treatment: Other: Supervised Exercise; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 588
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inger Mechlenburg, DMSc; Phone Number: +45 21679062; Email: inger.mechlenburg@clin.au.dk
• Study Contact Backup: Name: Andreas Bentzen, MHSc; Phone Number: +45 53109112; Email: andreas.bentzen@clin.au.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Inger Mechlenburg, DMSc; Phone Number: +45 21679062; Email: inger.mechlenburg@clin.au.dk
    • Contact: Andreas Bentzen, MSc; Phone Number: +45 53109112; Email: andreas.bentzen@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Distal radius fracture treated surgically or non-surgically
• Willing and able to give informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Other: Usual Care; Verbal 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).
Experimental: Supervised Exercise in addition to Usual Care (intervention)	Other: Supervised Exercise; Verbal 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).; Other: Usual Care; Verbal 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at baseline, 3 months and 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months and 6 months follow-up
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.	Baseline, 3 months and 6 months follow-up
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.	Baseline, 3 months and 6 months follow-up
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.	Baseline, 3 months and 6 months follow-up
EuroQol 5 Dimensions (EQ-5D-5L)	Quality of life measured using the EuroQol 5 Dimensions (EQ-5D-5L) a validated, generalized and standardized instrument comprising a Visual Analogue Scale (VAS) measuring self-rated health and a health status instrument, consisting of a five-level response (no problems, some problems, moderate problems, severe problems and unable) for five domains related to daily activities; (i) mobility, (ii) selfcare, (iii) usual activities, (iv) pain and discomfort and (v) anxiety and depression. Responses to the health status classification system are converted into an overall score using a published utility algorithm for the Danish population. The EQ-5D health status scale ranges from negative scores -0.594 [reflective of a patient's quality of life being worse than death], 0 [death], to 1 [perfect health]. A respondent's EQ-VAS gives self-rated health on a scale where the endpoints are labelled 'best imaginable health state' (100) and 'worst imaginable health state' (0).	Baseline, 3 months and 6 months follow-up
Self-Efficacy for Exercise scale (SEE)	A 9-item participant-reported questionnaire (total scores range from 0 to 90, higher scores indicate higher self-efficacy for exercise) will be used to assess the participants' confidence in their ability to exercise	Baseline, 3 months and 6 months follow-up
Exercise adherence measured by self-reported exercise frequency	Participants will be asked to indicate how many times in the preceding week they have done specific exercises for their injured hand and upper extremity, to assess engagement with the advised exercises after wrist fracture.	3 months and 6 months follow-up
Serious adverse events (SAEs)	All unexpected serious adverse events related to the randomized interventions will be recorded. These events will be reported by recruitment centers as they become aware of events. Serious adverse events are an adverse event that: results in death; is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapac-ity; is a congenital anomaly or birth defect; or is otherwise considered medically significant by the in-vestigator (i.e., medical events that may jeopardise the participant or may require an intervention to pre-vent one of the above characteristics/consequences).	3 months and 6 months follow-up
Adverse events (AEs)	Foreseeable adverse events will be recorded as complications both by recruitment centers and participants. AEs that are unrelated to the intervention will not be reported. AEs deemed related to the intervention that do not meet the SAE definition and are not classed as foreseeable as per the following (such as discomfort during performance of exercises), will also not be reported. Foreseeable adverse events include: increase in pain lasting more than one week; treatment-related exacerbations of other medical conditions that do not meet the definition of serious (for example angina after exertion); development of Complex Regional Pain Syndrome; surgery to the injured wrist (unless an adverse event directly related to the exercise intervention, in which case this would be an SAE); development of carpal tunnel syndrome requiring medical intervention (corticosteroid injection or surgery); wound complication in the injured wrist.	3 months and 6 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months and 6 months follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital Skejby
• Investigators: Principal Investigator: Inger Mechlenburg, DMSc, Aarhus University Hospital; Study Chair: Jan D. Rölfing, MD., Aarhus University Hospital; Study Chair: Per H. Gundtoft, MD., Aarhus University Hospital; Study Chair: Andreas Bentzen, MHSc, Aarhus University Hospital; Study Chair: David J. Keene, PhD, University of Oxford; Study Chair: Matthew Costa, MD, PhD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Therapy; Resistance training; Strengthening exercise
• Additional Relevant MeSH Terms: Fracture Dislocation; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Fractures, Bone; Arm Injuries; Joint Dislocations; Wrist Injuries; Radius Fractures; Behavior; Wrist Fractures; Colles' Fracture; Motor Activity
• Other Study ID Numbers: WISE-DK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized patient-level data will be shared with collaborators in the UK to be combined in an individual participant data meta-analysis. Anonymized patient-level data will also be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
• IPD Sharing Time Frame: Data will be available after publication of the trial
• IPD Sharing Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No