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Recruiting NCT07538323

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

No phase Interventional Distal Radius Fracture Colles Fracture Wrist Fracture Wrist Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supervised Exercise, Usual Care.
Who it may be relevant to
Registry conditions: Distal Radius Fracture, Colles Fracture, Wrist Fracture, Wrist Fractures. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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 uppe
  • 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).

Primary outcome measures

  • Patient-Rated Wrist Evaluation (PRWE) [Time frame: Measured at baseline, 3 months and 6 months follow-up]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus N

Identifiers

NCT: NCT07538323 · WISE-DK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗