An interventional study of Experimental (Structured postoperative physiotherapy) and Standard postoperative care in Emergency Abdominal Surgery, sponsored by University of Cyprus. Recruiting at 1 site in Cyprus. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University of Cyprus · Not applicable, Interventional, and Treatment
Emergency laparotomy is associated with high postoperative morbidity and mortality. This risk is particularly high among elderly patients, who often present with reduced physiological reserve, frailty, and multimorbidity.
The aim of this study is to evaluate the effect of a structured postoperative physiotherapy program in patients aged 65 years and older undergoing emergency laparotomy. The study will assess its impact on functional recovery and clinical outcomes.
This is a multicenter, parallel-group randomized controlled trial evaluating a structured postoperative physiotherapy program in older adults undergoing emergency laparotomy. Participants aged ≥65 years who undergo an index emergency laparotomy will be enrolled at Nicosia General Hospital (Cyprus) and the University Hospital of Heraklion (Greece) and randomized 1:1 to either (a) a standardized, progressive 5-day postoperative physiotherapy package (supervised early mobilization with progressive targets, coached breathing/airway clearance exercises, and supported self-practice with family/caregiver engagement) or (b) usual postoperative care as delivered in routine practice.
Randomization will occur after surgery once the participant is clinically stable on the surgical ward (including after ICU step-down when applicable), using a computer-generated allocation sequence. Functional recovery will be assessed using validated measures at prespecified time points during the index hospitalization and at follow-up (30 and 90 days). Key secondary outcomes include postoperative complications, postoperative pulmonary complications, length of stay, mortality, and health-related quality of life. Analyses will compare groups according to the intention-to-treat principle.
University of Cyprus is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Able to provide or have a legally authorized representative provide consent.
Able to maintain an upright standing position for at least one minute with minimal or no assistance.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a structured five-day postoperative physiotherapy program including progressively increasing mobilization, supervised therapeutic exercises, and respiratory training every two hours. A booklet with detailed exercise instructions and a daily log for recording repetitions will be provided. A family member will be informed to support adherence. Nutritional risk will be assessed and its association with functional recovery will be evaluated
Behavioral: Experimental (Structured postoperative physiotherapy)
Participants in the control group will receive standard postoperative physiotherapy according to usual hospital practice. This includes general mobilization without a structured or progressively increasing protocol. Instruction in deep breathing exercises and voluntary coughing will be provided only once on the first postoperative day, without further supervision or reinforcement. No lower limb strengthening or muscle pump exercises will be implemented, and no exercise booklet, daily monitoring, or structured adherence tracking will be provided.
Other: Standard postoperative care
A structured five-day postoperative physiotherapy program including progressively increasing mobilization, supervised therapeutic exercises, and respiratory training every two hours. Participants will receive an exercise booklet and daily log for monitoring adherence.
Also known as: Treatment Group
Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring.
Also known as: Controll Group
Functional Status
Functional independence measured with the Barthel Index of Activities of Daily Living (ADL), total score 0-100. Higher scores indicate better function/greater independence. Scores will be compared with baseline (preoperative functional level) and reassessed at follow-up (At hospital discharge, and at 30 and 90 days after discharge).
Time frame: At hospital discharge (6-15 days postoperatively on average), and at 30 and 90 days after discharge.
Handgrip strength (dynamometry),
Muscle strength will be assessed using a handgrip dynamometer. The participant will be seated, with the elbow of the dominant hand supported on a stable surface at a 90° angle. The participant will then be instructed to squeeze the dynamometer handle as forcefully as possible. The test will be repeated three (3) times, and the highest value recorded will be used for analysis. Measurements of \<20 kg for women and \<30 kg for men will be considered indicative of reduced muscle strength.
Time frame: At hospital discharge (6-15 days postoperatively on average)
sit-to-stand performance,
Participants attempt to stand from a 47-cm chair without using their arms, completing as many repetitions as possible within 30 seconds. Performance \<8 repetitions indicates reduced functional ability.
Time frame: At hospital discharge (6-15 days postoperatively on average).
frailty (mFI-11),
Frailty assessed with the 11-item Modified Frailty Index (mFI-11). The score can be reported as a count (0-11) or as a proportion (0.00-1.00) / percentage (0-100%). Higher scores indicate greater frailty and worse prognosis
Time frame: Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomization
nutritional risk (MUST),
Nutritional risk assessed with the Malnutrition Universal Screening Tool (MUST), total score 0-6. Higher scores indicate higher risk of malnutrition (0=low, 1=medium, ≥2=high)
Time frame: Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomization
postoperative complications (Clavien-Dindo),
A 5-grade classification system used in surgery to standardize the reporting of postoperative complications based on the severity of the intervention required to treat them.
Time frame: From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
Respiratory complications (Melbourne Score)
The Melbourne Group Scale (MGS) was developed by physiotherapists as an objective tool for the diagnosis of postoperative pulmonary complications (PPCs). It comprises eight standardized clinical criteria, including abnormal breath sounds on auscultation, increased sputum production, fever, hypoxaemia, chest imaging findings consistent with atelectasis or consolidation, elevated white blood cell count, physician diagnosis of pneumonia, and prolonged requirement for high oxygen supplementation. A postoperative pulmonary complication is diagnosed when four (4) or more of these eight criteria are present within a 24-hour period.
Time frame: From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
Hospital length of stay,
Number of days in Hospital
Time frame: From admission to hospital discharge (6-15 days postoperatively average)
30-day mortality
Living stadus in 30 Days after discharge
Time frame: 30 Days after discharge
health-related quality of life (EQ-5D at 30 and 90 days)
The EQ-5D, developed by the EuroQol Group, is a widely validated measure of health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five severity levels, and a visual analogue scale (0-100) for global health. Responses produce a five-digit health state code (e.g., 11111 = best health). A validated Greek version is available.
Time frame: The tool will be used at 30 and 90 days after discharge via telephone follow-up.
Plan to share: No — Individual participant data will not be publicly available due to privacy and confidentiality considerations and institutional data protection policies.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.
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