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

NCT07538323 | Not Yet Recruiting DMC

• 1 other identifier: WISE-DK
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Distal Radius Fracture; Colles Fracture; Wrist Fracture; Wrist Fractures; Fracture Arm

Keywords

Exercise; Therapy; Resistance training; Strengthening exercise

Outcome Measures

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.

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

Secondary Outcomes (9)

• Wrist pain subscale measured using the Patient Rated Wrist Evaluation (PRWE)

  Baseline, 3 months and 6 months follow-up

• Wrist function subscale measured using the Patient Rated Wrist Evaluation (PRWE)

  Baseline, 3 months and 6 months follow-up

• PROMIS Physical Function Upper Extremity-Short Form 7a

  Baseline, 3 months and 6 months follow-up

• QuickDASH

  Baseline, 3 months and 6 months follow-up

• EuroQol 5 Dimensions (EQ-5D-5L)

  Baseline, 3 months and 6 months follow-up

Other Outcomes (1)

• Health resource use

  3 months and 6 months follow-up

Study Arms (2)

Supervised Exercise in addition to Usual Care (intervention)

EXPERIMENTAL

Other: Supervised Exercise; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Supervised Exercise OTHER

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).

Supervised Exercise in addition to Usual Care (intervention)

Usual Care OTHER

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).

Supervised Exercise in addition to Usual Care (intervention); Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital Skejby: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Wrist Fractures; Colles' Fracture; Motor Activity

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures; Behavior

Study Officials

• Inger Mechlenburg, DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Inger Mechlenburg, DMSc

CONTACT

+45 21679062; inger.mechlenburg@clin.au.dk

Andreas Bentzen, MHSc

CONTACT

+45 53109112; andreas.bentzen@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial
• Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.

Locations

DK (1)