NCT06184880

Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer

Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Centre Hospitalier de Valence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

APAORL2 study aims to evaluate the efficacy of a physical activity program on the sedentary and physical activity level during the 18-month program. APAORL2 study is a randomized, open label, controlled, monocentric, intervention study that will be conducted among 96 patients treated for localized upper aerodigestive tract cancer.

Detailed description

Rationale: A sedentary lifestyle has been clearly shown to reduce survival in cancer patients, mainly through metabolic changes. While the notions of sedentary lifestyle and physical inactivity overlap, they are not entirely synonymous. The aim of this study is to examine the contribution of a physical activity program, during the treatment and post-treatment phases, in addition to the current care program, on behavior change (i.e. sedentary behaviors and Physical activity levels), quality of life and fatigue in patients with upper aerodigestive tract cancer The primary objective is to show that the experimental group (combining the current care pathway + physical Activity program) has lower levels of sedentary behaviour and higher levels of physical activity than the control group (following the classic care pathway with Physical Activity awareness) after the treatment phase. Patients will be randomly assigned to one of the 2 arms of the study according to a 1:1 ratio: Group A: control group: standard care with recommendations on physical activity. Group B: experimental group: Physical activity program

Conditions

• Upper Aerodigestive Tract Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
BEHAVIORAL	behavioral	International Physical Activity (IPAQ) Questionnaire, Quality of Life Questionnaire QLQ-C30, HN 43 questionnaire, Multidimensional Fatigue Inventory (MFI) Questionnaire, Big Five Inventory Questionnaire, illness Identity Questionnaire,
OTHER	Sedentary	Actimetry (cumulative time without movement over 24h, prolonged sedentary periods \>30 min without movement. Continuous recording 7 days prior to visit T0, T1, T2, T3, T4, T5

Timeline

• Start date: 2024-03-19
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2023-12-28
• Last updated: 2026-03-19

Locations

1 site across 1 country: France