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Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

Effectiveness of a Digital Prehabilitation Programme Compared With Usual Care in Patients Awaiting Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Superiority Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07643480
Enrollment
60
Registered
2026-06-11
Start date
2026-09-15
Completion date
2026-12-31
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injury

Keywords

Anterior Cruciate Ligament, ACL Reconstruction, Prehabilitation, Digital Health, Exercise Therapy, Telerehabilitation, Quadriceps Strength, Knee Function

Brief summary

Background Prehabilitation prior to anterior cruciate ligament reconstruction (ACLR) has been shown to improve preoperative knee function, enhance quadriceps strength, and optimize postoperative recovery. However, access to supervised prehabilitation programmes remains limited. Digital health interventions may improve accessibility, adherence, and continuity of care. Objective To determine whether a structured digital prehabilitation programme is more effective than usual care in improving quadriceps strength and functional outcomes after ACL reconstruction. Methods/design This study is a single-centre, parallel-group, assessor-blinded randomised controlled trial. Adult participants scheduled for primary ACL reconstruction will be randomly allocated to either a usual care group or a digital prehabilitation group. The intervention group will complete a 4-week structured digital prehabilitation programme prior to surgery. Outcomes will be assessed preoperatively and up to 12 weeks postoperatively. Expected Results The digital prehabilitation programme is expected to improve preoperative knee status and enhance postoperative quadriceps strength and functional recovery compared to usual care.

Interventions

OTHERDigital Prehabilitation Programme

Participants in the intervention group will undergo a structured 4-week digital prehabilitation programme prior to anterior cruciate ligament reconstruction.The programme includes:- Range of motion exercises targeting knee extension and flexion- Strength training focusing on quadriceps, hamstrings, and hip musculature- Neuromuscular and balance training- Patient education on surgical procedure, postoperative expectations, and recovery process- Lifestyle optimisation advice including pain management, nutrition, and emotional supportThe intervention will be delivered through a digital platform with guided exercise sessions and remote supervision.Frequency: 3 sessions per weekDuration: approximately 10-20 minutes per sessionThe programme aims to optimise preoperative knee function, improve quadriceps strength, and enhance postoperative recovery outcomes.

OTHERUsual Care

Participants in the control group will receive standard preoperative care, which may include general advice and routine clinical follow-up, but no structured prehabilitation programme.Participants will not receive a supervised or digital exercise intervention prior to surgery.

Sponsors

Alejandro Caña Pino
Lead SponsorOTHER
University of Extremadura
CollaboratorOTHER
University of Évora
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Adults 18-55 years * Diagnosed ACL rupture * Scheduled for primary ACL reconstruction * Waiting ≥4 weeks before surgery

Exclusion criteria

* Multiligament injury * Severe comorbidities * Previous ACL surgery same knee

Design outcomes

Primary

MeasureTime frameDescription
Quadriceps Isometric Strength12 weeks postoperativeMaximum isometric quadriceps strength measured in seated position at 90° knee flexion. Three repetitions will be recorded, and the highest value will be used

Secondary

MeasureTime frameDescription
Knee Extension Range of MotionBaseline and preoperative (prior to surgery)Passive knee extension will be measured in degrees using a standard goniometer. Full extension (0°) will be considered optimal preoperative status
Knee Pain IntensityUp to 12 weeks postoperativePain intensity will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain)
Knee Injury and Osteoarthritis Outcome Score (KOOS)Up to 12 weeks postoperativeKnee-related symptoms, pain, function in daily living, sport and recreation function, and knee-related quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Each subscale is scored from 0 to 100, where 0 represents extreme problems and 100 represents no problems (best outcome).
Single Leg Hop DistanceUp to 12 weeks postoperativePatients will perform a single-leg hop for maximum distance. The distance will be measured in centimetres
Pain CatastrophizingUp to 12 weeks postoperativePain-related catastrophic thinking will be assessed using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52, where higher scores indicate greater levels of pain catastrophizing (worse outcome).
DASS-21. Depression, Anxiety and StressUp to 12 weeks postoperativePsychological status will be assessed using the Depression Anxiety Stress Scales (DASS-21). The scale consists of three subscales (depression, anxiety, and stress), each ranging from 0 to 42 after score multiplication. Higher scores indicate greater emotional distress (worse outcome).

Contacts

CONTACTAlejandro Caña Pino, PhD
alejandrocp@unex.es927251220
CONTACTJoão Paulo Sousa, PhD
jsousa@uevora.pt919662332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026