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

University of Aarhus

Status: Enrolling

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

Treatments: Other: Supervised Exercise; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07538323

WISE-DK

Details and patient eligibility

About

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.

Enrollment: 588 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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588 participants in 2 patient groups

Supervised Exercise in addition to Usual Care (intervention)

Experimental group

Treatment:

Other: Usual Care

Other: Supervised Exercise

Usual Care

Active Comparator group

Treatment:

Other: Usual Care