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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Inger Mechlenburg, DMSc contact

+45 21679062

inger.mechlenburg@clin.au.dk

Andreas Bentzen, MHSc contact

+45 53109112

andreas.bentzen@clin.au.dk

Denmark1 site, 1 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

    Recruiting

Other trials in Denmark

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 groups in NCT07538323
Study groupRoleWhat they receive
Supervised Exercise in addition to Usual Care (intervention)ExperimentalNot described
Receives: Other: Supervised Exercise; Other: Usual Care
Usual CareActive comparatorNot described
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Measured at baseline, 3 months and 6 months follow-up

Secondary outcomes (9)
  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.

    Measured: Baseline, 3 months and 6 months follow-up

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted20 Apr 2026
  2. Study start12 May 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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.

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.

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