Ch Valence
Valence, 26000, France
Location status: Recruiting
NCT Number: NCT06184880
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Valence, 26000, France
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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,
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
Other names: Physical Activity level
Time frame: Change between baseline and 3, 6, 12 months and 18 months
cumulative time without movement over a day, as well as prolonged sedentary periods (>30min without movement): continuous recording 7 days prior to hospital visits
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Physical Activity level
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life
Time frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life
Time frame: Change between baseline and 3 months
fatigue level
Time frame: Change between baseline and 3 months
measure personality traits.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier de Valence
Other
Effect of Physical Activity Program on Sedentary and Physical Activity Level of Patients With Upper Aerodigestive Tract Cancer
Acronym: APAORL2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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