ACTIOHN: Activity as medicine in oncology for head and neck
Not Applicable
- Conditions
- Head and Neck CancerCancer
- Registration Number
- ISRCTN82505455
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37624789/ (added 29/08/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
1. >= 16-year-old.
2. Able to provide informed consent.
3. Diagnosed with HaNC for treatment with curative intent.
4. Between time of diagnosis and up to 8 weeks post-treatment.
5. Classified as low-medium risk according to an exercise risk stratification tool.
Exclusion Criteria
1. Treated with palliative intent, as decided by the HNC multidisciplinary team.
2. Classified as high risk according to an exercise risk stratification tool, or has any other unstable or uncontrolled medical condition associated with increased risk during exercise.
3. Unable to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Exercise uptake: percentage of eligible patients that agreed to participate. Reasons for refusal also will be sought. At 8 week post intervention<br>2. Exercise adherence:<br>2.1. Exercise programme adherence: Percentage of the total prescribed exercise sessions completed. At 8 week post intervention<br>2.2. Permanent treatment discontinuation: permanent discontinuation of the exercise programme before the end of week 8; <br>2.3. Treatment interruption: percentage of participants that missed at least three continuous scheduled training sessions; At 8 week post intervention<br>2.4. Dose modification: number of exercise sessions where the prescribed exercise was reduced by the participant, or reduced according to the exercise regressions embedded in each participant’s exercise programme; At 8 week post intervention<br>2.5. Early session termination: number of sessions terminated early by the participant. At 8 week post intervention
- Secondary Outcome Measures
Name Time Method Pre- and post-intervention measures of physical fitness: <br>1. Aerobic endurance (measured using 6-Minute Walk Test) baseline and 8-week post intervention<br>2. Lower body muscular strength and endurance (measured using 30-Second Chair Stand Test) baseline and 8-week post intervention<br>3. Upper body muscular strength and endurance (measured using the Arm Curl Test) baseline and 8-week post intervention<br>4. Agility and dynamic balance (measured using 8-Foot Up-and-Go Test) baseline and 8-week post intervention<br>5. Shoulder and neck range of motion (measured using goniometric measurements) baseline and 8-week post intervention<br><br>Pre- and post-intervention patient-reported measures <br>6. Fatigue (Multidimensional Fatigue Symptom Inventory - Short Form) baseline and 8-week post intervention<br>7. Quality of life (SF-36) baseline and 8-week post intervention<br>8. Physical activity levels (International Physical Activity Questionnaire - Short Form) baseline and 8-week post intervention