RehabilitationPREHABNCT07820592
Prehabilitation Before Surgery: A Strategy To Accelerate Recovery After Rotator Cuff Repair?
A study testing Prehabilitation in people with Rehabilitation and Rotator Cuff, run by Laura Castillo Vejar at 1 site in Chile.
Trial summary
A rotator cuff tear is a structural injury to one or more tendons of the rotator cuff, ranging from degenerative changes to partial or complete tears. Rotator cuff tears are among the most common causes of shoulder pain and disability, particularly in middle-aged and older adults, and their prevalence increases with… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rehabilitation, Rotator Cuff, Prehabilitation
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 3 Sep 2026to 10 Nov 2026
- Phase
- Interventional
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
- Men or women
- Over 50 years of age
- Awaiting arthroscopic surgery for rotator cuff repair of one or more tendons
- Signed informed consent.
Who cannot join
- Patients with a history of previous shoulder surgery ( in the contralateral shoulder)
- Patients with a massive irreparable rotator cuff tears
- Patientes with a history of infiltration in an injured shoulder
- Uncontrolled or undiagnosed sleep disorders
- The presence of mental or neurological illness, inability to read or follow instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prehabilitation Before Surgery: A Strategy To Accelerate Recovery After Rotator Cuff Repair? A Randomized Pilot Clinical Trial
A rotator cuff tear is a structural injury to one or more tendons of the rotator cuff, ranging from degenerative changes to partial or complete tears. Rotator cuff tears are among the most common causes of shoulder pain and disability, particularly in middle-aged and older adults, and their prevalence increases with age. Population studies report a prevalence of complete tears around 20% to 22%, while in cohorts of individuals over 70 years of age, it can exceed 50%. The risk of tearing is associated with advanced age, dominant arm involvement, trauma, heavy labor, and male sex.
Read the detailed description
Physiological stress and adverse psychological factors can negatively interfere with postoperative recovery. To address this challenge, prehabilitation emerges as a comprehensive strategy that actively prepares patients before surgery, aiming to improve physical condition, optimize nutritional status, and implement cognitive interventions to reduce stress and anxiety. However, the application of prehabilitation in musculoskeletal injuries remains controversial. The main interventions in musculoskeletal injuries are based on strengthening exercises, balance and proprioceptive work, combined to a lesser extent with preoperative education and the use of neuromuscular electrical stimulation.
- Conditions
- Rehabilitation, Rotator Cuff, Prehabilitation
- Being tested
- Prehabilitation
- Keywords
- prehabilitation, rotator cuff repair, shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Two 60-minute prehabilitation sessions were conducted one week prior to surgery by kinesiologist specializing in musculoskeletal rehabilitation. The first session consisted of a power point presentation covering: (1) postoperative stages; (2) biopsychosocial factors influencing pain management; (3) the correct use of the sling and abduction cushion. The second session required participants to bring a companion for demostrations and practice of: (1) strategies for performing activities of daily living; (2) permitted movements and restrictions during the first postoperative weeks; (3) distal mobility exercises and (4) sleep hygiene strategies.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | 2 prehabilitation sessions before surgery + standard postoperative ohysiotherapy rehabilitation Receives: Other: Prehabilitation |
| Control group | No intervention | Received a standard ohysical therapy program alone, Following arthroscopic surgery, all participants were immobilized with a sling and abduction cushion for 3 weeks. Participants attended physical therapy 2 to 3 times per week, with each session consisting of 60 minutes of intervention. The same exercise protocol based on the consensus guidelines of The American Society of Shoulder and Elbow Therapists was followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff (WORC)
It consists of 21 questions, addressing physical symptoms, sports and recreation, work and recreation, work, life studies and emotions. All dimensions were calculated and will be reported as a percentage. The WORC (Western Ontario Rotator Cuff Index) has an absolute maximum score of 2100 points, representing the worst possible symptoms or the highest level of shoulder disability.
Measured: 4,8 and 12 week
Secondary outcomes (7)
Pain intensity
The intensity of the pain is assessed considering a scale from 0 to 10. 0 being no pain and 10 being the maximum pain perceived.
Measured: 4,8 and 12 week
Kinesiophobia (TSK-11)
The tampa Kinesiophobia scale (TSK-11) will be used, being a valid, self-reported assessment instrument of 44 point. The maximum score is 44 points correlates with higher kinesiophobia
Measured: 4,8 and 12 week
Catastrophizing (PCS)
A 13-item self-administered questionnaire will be used, designed to measures a person is tendency to magnify, ruminate, or feel helpless in the face of pain. The maximum score on the Pain Catastrophizing Scale (PCS) is 52 points.
Measured: 4,8 and 12 week
Disability (QUICKDASH)
Evaluates disability and symptom severity for conditions affecting the arm, shoulder, and hand. 11 items rates on a 5-point likert scale (requiring at least 10 answered items to calculate). The maximum score on the QuickDASH questionnaire is 100 points, indicating the highest level of disability or functional limitation in the upper extremity.
Measured: 4,8 and 12 week
Grip Strength
A dynamometer will be used to quantify the grip strength of both arms.
Measured: 4,8 and 12 week
Mobility (ROM)
A goniometer is used to measure the degrees of arm movement
Measured: 4,8 and 12 week
Sleep quality (PSQI)
The Pittsburgh sleep quality index is a questionnaire that measures sleep quality and its disturbances in the last month. The maximum score on the Pittsburgh Sleep Quality Index (PSQI) is 21 points. Each component is rated on a scale of 0 to 3, where 0 means no difficulty and 3 represents a serious problem.
Measured: 4,8 and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start3 Sep 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- A two-arm parallel randomized clinical trial with repeated measures
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Castillo Vejar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Castillo Vejar, Clinica Redsalud
- Investigators
- Laura Castillo, Msc, Principal investigator, Clinica Mayor RedSalud Temuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820592
- Sponsor's protocol ID
- PREHAB-MR
- Acronym
- PREHAB
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No