Distal Radius FractureWISE-DKNCT07538323
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
A study testing Supervised Exercise in people with Distal Radius Fracture and Colles Fracture, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distal Radius Fracture, Colles Fracture, Wrist Fracture
- What is being tested?
- Supervised Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 1 siteDenmark
- Study dates
- 12 May 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture treated surgically or non-surgically
- Willing and able to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Inger Mechlenburg, DMSc, +45 21679062, inger.mechlenburg@clin.au.dk
Andreas Bentzen, MSc, +45 53109112, andreas.bentzen@clin.au.dk
About this study
Official title: 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?
Read more
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.
- Being tested
- Supervised Exercise, Usual Care
- Keywords
- Exercise, Therapy, Resistance training, Strengthening exercise
- Medical subject headings
- Wrist Fractures, Colles' Fracture, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised ExerciseOther
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).
Usual CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise in addition to Usual Care (intervention) | Experimental | Not described Receives: Other: Supervised Exercise; Other: Usual Care |
| Usual Care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, 3 months and 6 months follow-up
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 3 months and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start12 May 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Sponsor
- Investigators
- Inger Mechlenburg, DMSc, Principal investigator, Aarhus University HospitalJan D. Rölfing, MD., Study chair, Aarhus University HospitalPer H. Gundtoft, MD., Study chair, Aarhus University HospitalAndreas Bentzen, MHSc, Study chair, Aarhus University HospitalDavid J. Keene, PhD, Study chair, University of OxfordMatthew Costa, MD, PhD, Study chair, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538323
- Sponsor's protocol ID
- WISE-DK
- Acronym
- WISE-DK
- Status last verified
- Nov 2026
- First submitted
- 6 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07538323
- Acronym / sponsor ID
- WISE-DK / WISE-DK
- Keywords
- Exercise, Therapy, Resistance training, Strengthening exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- 12 May 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise in addition to Usual Care (intervention) | Experimental | Other: Supervised Exercise, Other: Usual Care |
| Usual Care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Distal radius fracture treated surgically or non-surgically
- Willing and able to give informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised ExerciseVerbal 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 | Supervised Exercise in addition to Usual Care (intervention) |
| Usual CareVerbal 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). | Other | Supervised Exercise in addition to Usual Care (intervention), Usual Care |
Primary outcome
Patient-Rated Wrist Evaluation (PRWE)
Time frame: Measured at baseline, 3 months and 6 months follow-up
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.
9 secondary outcomes
Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE)
Time frame: Baseline, 3 months and 6 months follow-up
Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE)
Time frame: Baseline, 3 months and 6 months follow-up
PROMIS Physical Function Upper Extremity-Short Form 7a
Time frame: Baseline, 3 months and 6 months follow-up
QuickDASH
Time frame: Baseline, 3 months and 6 months follow-up
EuroQol 5 Dimensions (EQ-5D-5L)
Time frame: Baseline, 3 months and 6 months follow-up
Self-Efficacy for Exercise scale (SEE)
Time frame: Baseline, 3 months and 6 months follow-up
Exercise adherence measured by self-reported exercise frequency
Time frame: 3 months and 6 months follow-up
Serious adverse events (SAEs)
Time frame: 3 months and 6 months follow-up
Adverse events (AEs)
Time frame: 3 months and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 1
Impact of Early ADL Education on Outcomes Post DRF ORIF
Distal Radius Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inger Mechlenburg, DMSc principal investigator
Aarhus University Hospital
Jan D. Rölfing, MD. study chair
Aarhus University Hospital
Per H. Gundtoft, MD. study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise in people with Distal Radius Fracture and Colles Fracture, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inger Mechlenburg, DMSc (+45 21679062, inger.mechlenburg@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (PRWE) (time frame: Measured at baseline, 3 months and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.