Clinical trial · Interventional
Develop and Test the 'Multi-Faced Continuous Exercise Program' in Operable Head and Neck Cancer Patients
School of Nursing, College of Medicine, National Taiwan University
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Due to the disease location and related treatments in head and neck areas following with concurrent chemoradiation therapy (CCRT), patients might suffer a series of acute distress and limit their physical activities. Limited physical activities might further cause dysfunction in both the upper body and general physical function. Purposes: This 3-year project will be conducted for three folds, with the purposes to (1) longitudinally examine the upper body function (mouth open abilities/trismus, neck stiffness/flexibility, shoulder function, myofascial pain, and upper arm muscle strengths) and general physical fitness; and (2) develop a 20-week continuous exercise program and test of its effects on improving upper body function, general physical function, fatigue, and quality of life in operable HNC in the first year of being diagnosed as cancer. Method: The eligible subjects will be newly diagnosed operable HNC patients. For research purpose (1) (Phase 1), we will conduct the data collection for continuous and follow patients for 12 months (Pre-operation, post-op 1, 3, 6, 12 months,/ T1-T5, respectively) for fatigue, upper body function and general physical fitness, and quality of life. A total of 130 subjects are planned to be recruited based on the sample size calculation. For research purpose (2) (Phase 2), from the second year, the 20-week "Multi-Faced Continuous Exercise Program" will be developed and tested in newly diagnosed operable HNC patients, while compare to those standard care control group of their differences in preventing physical dysfunction and increasing physical function for a 20-week period on post-op 1, 3, \& 6 months (T0-T2, respectively). Data will be analyzed by both descriptive analysis and the Generalized Estimating Equation (GEE). There will be 130 subjects in each group (N=260 total) based on power analysis principles. Expected Outcome: The results will increase our knowledge about the changes in physical activities, physical function, and dysfunction; and the levels of the effectiveness of a continuous exercise program on increasing head and neck cancer patients' physical function and quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise intervention program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- All patients received care as usual. Patients receive wound care and pain management post-surgery. Before RT, generally advising to do neck stretch and mouth opening exercises. Telephone follow-up was not provided to usual care group. Furthermore, patients in usual care group went to receive physical therapy were free to do. During the follow-up period, well-trained research nurses (assessors) recorded their physical therapy sections.
- type
- EXPERIMENTAL
- label
- Exercise intervention programs
- description
- Based on our previous literature review, we will have two major parts of exercises in our intervention: (1) Upper Body Exercise (stretching in shoulder and neck, and mouth-opening); and (2) General Physical Function Training.
- interventionNames
- Behavioral: Exercise intervention program
Primary outcomes (24)
- measure
- Shoulder Pain and Disability Index (SPADI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible subjects were adult patients (≥20 years old) with newly diagnosed squamous cell type of HNC patients who received tumor excision and neck dissection (either MRND or SND) within 3-4 weeks * Part of subjects might with postoperative RT or CCRT Exclusion Criteria: * Patients unable to communicate
References
Publications (47)
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- BACKGROUNDYang JL, Lin JJ. Reliability of function-related tests in patients with shoulder pathologies. J Orthop Sports Phys Ther. 2006 Aug;36(8):572-6. doi: 10.2519/jospt.2006.2133. PMID 16915978
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- BACKGROUNDWeymuller EA Jr, Alsarraf R, Yueh B, Deleyiannis FW, Coltrera MD. Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Arch Otolaryngol Head Neck Surg. 2001 May;127(5):489-93. doi: 10.1001/archotol.127.5.489. PMID 11346422
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- BACKGROUNDLee YH, Lai YH, Yueh B, Chu PY, Chen YJ, Chen SC, Wang CP. Validation of the University of Washington Quality of Life Chinese Version (UWQOL-C) for head and neck cancer patients in Taiwan. J Formos Med Assoc. 2017 Apr;116(4):249-256. doi: 10.1016/j.jfma.2017.01.002. Epub 2017 Feb 15.