Oral CancerRISENCT07857096
Rehabilitation Through Individualized Support and Exercise
A study testing Tailored physiotherapy program for early mobilization after oral cancer surgery in people with Oral Cancer and Head and Neck Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Head and Neck Cancer
- What is being tested?
- Tailored physiotherapy program for early mobilization after oral cancer surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Sep 2026to 1 Jan 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically confirmed oral cancer.
- Planned free fibula or DCIA flap reconstruction.
- Ability to provide written informed consent.
- Sufficient comprehension of Dutch to complete questionnaires.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
UZ Leuven
Leuven, 3000
Lina Van Lint, 0475349544, lina.vanlint@kuleuven.be
Jeroen Van Dessel, Dr.
About this study
Official title: Feasibility and Compliance of a Tailored Physiotherapy Program for Early Mobilization After Oral Cancer Surgery
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.
- Conditions
- Oral Cancer, Head and Neck Cancer
- Being tested
- Tailored physiotherapy program for early mobilization after oral cancer surgery
- Keywords
- Mouth Neoplasms, early mobilization, Physiotherapy, perioperative rehabilitation
- Medical subject headings
- Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored physiotherapy program for early mobilization after oral cancer surgeryOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients get a tailored physiotherapy program for early mobilization after oral cancer surgery Receives: Other: Tailored physiotherapy program for early mobilization after oral cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first postoperative physiotherapy session until hospital discharge, anticipated from day 1 to 10 after surgery.
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.
Measured: At hospital discharge, anticipated 10 days after surgery.
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.
Measured: At hospital discharge, anticipated 10 days after surgery.
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.
Measured: At hospital discharge, anticipated 10 days after surgery.
Adherence to prescribed physiotherapy sessions
Adherence will be assessed as the percentage of prescribed postoperative physiotherapy sessions completed by each participant. This percentage will be calculated as the number of completed sessions divided by the number of prescribed and clinically eligible sessions during the postoperative hospital stay, multiplied by 100. A completed session is defined as a supervised physiotherapy session that is initiated and delivered as planned or with clinically indicated adaptations. Sessions that are initiated but terminated before completion will be classified as incomplete, with the reason for termination recorded. Sessions withheld or terminated because the participant is clinically ineligible for physiotherapy or because of safety concerns will be reported separately and excluded from the denominator. Scores range from 0% to 100%, with higher percentages indicating greater adherence.
Measured: From the first prescribed postoperative physiotherapy session until hospital discharge, anticipated from day 1 to 10 after surgery.
Therapist-rated adherence to physiotherapy
Therapist-rated in-session engagement will be assessed immediately after each postoperative physiotherapy session using the Sport Injury Rehabilitation Adherence Scale (SIRAS). The SIRAS consists of three items, each scored from 1 to 5. Item scores are summed to obtain a session-level total score ranging from 3 to 15, with higher scores indicating greater in-session engagement. The reported participant-level outcome will be the mean of the session-level total scores across all assessed sessions.
Measured: Immediately after each postoperative physiotherapy session, from the first session until hospital discharge, anticipated from day 1 to 10 after surgery.
Secondary outcomes (11)
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.
Measured: From baseline (8 days before surgery) until the end of follow-up (10 days after discharge).
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.
Measured: At baseline, 8 days before surgery
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.
Measured: At baseline, 8 days before surgery
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.
Measured: At baseline, 8 days before surgery, and at the start of the intervention, anticipated 1 day after surgery.
Functional lower limb performance measured by the Five Times Sit-to-Stand Test
Functional lower limb performance will be assessed using the Five Times Sit-to-Stand Test (5xSTS). The time required to complete five consecutive sit-to-stand repetitions will be recorded in seconds. Shorter completion times indicate better functional lower limb performance. Completion times will be reported at each assessment time point.
Measured: At baseline, 8 days before surgery, and at hospital discharge, anticipated 10 days after surgery.
Functional exercise capacity measured by the Six-Minute Walk Test
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The total distance walked during six minutes will be recorded in metres. Greater walking distances indicate better functional exercise capacity. Walking distances will be reported at each assessment time point.
Measured: At baseline, 8 days before surgery, and at hospital discharge, anticipated 10 days after surgery.
Handgrip strength
Handgrip strength will be assessed using a Jamar Hydraulic Hand Dynamometer and recorded in kilograms. Three attempts will be performed for each hand at each assessment time point. The mean of the three attempts will be calculated separately for the right and left hand, and results will be reported separately by hand. Higher values indicate greater handgrip strength.
Measured: At baseline, 8 days before surgery, and at hospital discharge, anticipated 10 days after surgery.
Pain intensity
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Pain scores will be recorded three times daily from the preoperative baseline assessment until 10 days after hospital discharge.
Measured: From baseline (8 days before surgery) until the end of follow-up (10 days after discharge).
Perceived exertion during physiotherapy
Perceived exertion will be assessed using the Borg Rating of Perceived Exertion (RPE) scale at the end of each supervised postoperative physiotherapy session. The scale ranges from 6 (no exertion) to 20 (maximal exertion), with higher scores indicating greater perceived exertion. The reported participant-level outcome will be the mean of the session-level ratings across all assessed postoperative physiotherapy sessions.
Measured: At the end of each supervised postoperative physiotherapy session, from the first session until hospital discharge, anticipated from day 1 to 10 after surgery.
Length of hospital stay
Length of hospital stay will be recorded as the number of days from surgery until hospital discharge.
Measured: From the day of surgery until hospital discharge, anticipated 10 days after surgery.
Postoperative complications
Postoperative complications will be recorded and classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events are graded from 1 to 5, with higher grades indicating greater severity: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to the adverse event). Higher grades therefore indicate a worse outcome. No overall score is calculated.
Measured: From surgery until the end of follow-up (12 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857096
- Sponsor's protocol ID
- S71815
- Acronym
- RISE
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality, ethical considerations, and institutional data protection policies.