Rehabilitation Through Individualized Support and Exercise
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Oral cancer, the most prevalent form of head and neck malignancy, represents a major global health burden, with over 370,000 new cases annually according to the World Health Organization. Surgical resection with free flap reconstruction remains the gold standard for curative treatment, yet it often entails significant functional and physical impairment. The surgical procedure often involves tumor resection and reconstruction. Postoperative complications such as dysphagia, reduced masticatory function, and prolonged immobility frequently contribute to fatigue, loss of muscle mass, and delayed recovery, ultimately impacting quality of life and overall prognosis.
Loss of skeletal muscle mass, commonly observed in this patient population, is strongly associated with impaired physical performance, reduced treatment tolerance, and increased postoperative morbidity. Recent evidence underscores that early mobilization and structured physiotherapeutic interventions can mitigate these effects, enhance functional recovery, and reduce length of hospital stay across various surgical populations. In head and neck cancer specifically, early mobilization has been associated with shorter hospitalization and fewer complications, yet practical, standardized physiotherapy protocols remain scarce and poorly defined.
Despite inclusion of early mobilization principles in Enhanced Recovery After Surgery (ERAS) pathways, current head and neck cancer guidelines lack specific recommendations regarding the timing, intensity, and content of postoperative physical activity. Furthermore, evidence on patient compliance and feasibility of such interventions during the acute hospitalization phase is limited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Histologically confirmed oral cancer.
Planned free fibula or DCIA flap reconstruction.
Ability to provide written informed consent.
Disqualifiers
Severe psychiatric or neurocognitive impairment (e.g., dementia, Korsakoff syndrome, schizophrenia).
Hemodynamic instability or contraindication to mobilization.
Pre-existing neuromuscular disorders severely limiting mobility.
Trial design
Design model
Single group
Treatments tested in this trial
Tailored physiotherapy program for early mobilization after oral cancer surgery
Other interventionParticipants allocated to the intervention group will receive a structured, multicomponent exercise programme during the perioperative period in addition to usual care. The programme includes individually tailored aerobic, resistance, flexibility and functional exercises, supervised by trained healthcare professionals and progressively adapted according to the participant's clinical condition and recovery.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Achievement of the highest exercise progression level
The percentage of participants who achieve the highest exercise progression level of the postoperative physiotherapy programme before hospital discharge will be reported. The highest progression level is defined as Level 4. The percentage will be calculated as the number of participants achieving this level divided by the total number of participants included in the primary feasibility analysis (n=35), multiplied by 100.
Time frame
From the first postoperative physiotherapy session until hospital discharge, anticipated from day 1 to 10 after surgery.2
Patient-reported acceptability of the intervention
Patient-reported acceptability of the physiotherapy programme will be assessed using the Acceptability of Intervention Measure (AIM). The AIM consists of four items, each rated from 1 (completely disagree) to 5 (completely agree). The participant-level score will be calculated as the mean of the four item scores, ranging from 1 to 5. Higher scores indicate greater perceived acceptability.
Time frame
At hospital discharge, anticipated 10 days after surgery.3
Patient-reported appropriateness of the intervention
Patient-reported appropriateness of the physiotherapy programme will be assessed using the Intervention Appropriateness Measure (IAM). The IAM consists of four items, each rated from 1 (completely disagree) to 5 (completely agree). The participant-level score will be calculated as the mean of the four item scores, ranging from 1 to 5. Higher scores indicate greater perceived appropriateness.
Time frame
At hospital discharge, anticipated 10 days after surgery.4
Patient-reported feasibility of the intervention
Patient-reported feasibility of the physiotherapy programme will be assessed using the Feasibility of Intervention Measure (FIM). The FIM consists of four items, each rated from 1 (completely disagree) to 5 (completely agree). The participant-level score will be calculated as the mean of the four item scores, ranging from 1 to 5. Higher scores indicate greater perceived feasibility.
Time frame
At hospital discharge, anticipated 10 days after surgery.Secondary outcomes
1
Objectively measured physical activity
Physical activity will be continuously assessed using the Activ8 Physical Activity Monitor G2. Activity data will be collected throughout the perioperative period to quantify daily physical activity and sedentary behaviour. Participant diaries will be used to support interpretation of activity monitor data during the preoperative and post-discharge periods.
Time frame
From baseline (8 days before surgery) until the end of follow-up (10 days after discharge).2
Anxiety symptoms
Anxiety symptoms will be assessed preoperatively using the Generalized Anxiety Disorder 2-item scale (GAD-2), with a total score ranging from 0 to 6. Higher scores indicate greater anxiety symptom severity and therefore a worse outcome. Participants scoring ≥3 will additionally complete the Generalized Anxiety Disorder 7-item scale (GAD-7), with a total score ranging from 0 to 21. Higher GAD-7 scores indicate greater anxiety symptom severity and therefore a worse outcome.
Time frame
At baseline, 8 days before surgery3
Baseline physical activity
Baseline physical activity and sedentary behaviour will be assessed using the Simple Physical Activity Questionnaire (SIMPAQ). The SIMPAQ assesses time spent across five activity domains: time in bed, sedentary time, walking, structured exercise, and incidental physical activity. Outcomes are reported as time spent in each activity domain rather than as a total score; therefore, no overall minimum or maximum score or direction of better outcome applies.
Time frame
At baseline, 8 days before surgery4
Motivation for physical activity
Motivation for physical activity will be assessed using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The questionnaire assesses six forms of motivation: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation. Each subscale is scored from 0 to 4. Higher scores indicate a greater presence of the respective type of motivation. Higher identified, integrated, and intrinsic regulation scores reflect greater autonomous motivation (better outcomes), whereas higher amotivation reflects lower motivation (worse outcome). External and introjected regulation represent more controlled forms of motivation and cannot be uniformly interpreted as better or worse outcomes. No overall BREQ-3 total score is calculated.
Time frame
At baseline, 8 days before surgery, and at the start of the intervention, anticipated 1 day after surgery.Sponsors and contacts
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Source ClinicalTrials.gov
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