Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer (APAORL2)

March 17, 2026 updated by: Centre Hospitalier de Valence

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥18 years
  • newly diagnosed, histologically proven Upper Aerodigestive Tract Cancer, non-metastatic,
  • life expectancy ≥18 months
  • having a smartphone, tablet or computer with an internet connection enabling remote physical Activity sessions for the experimental group

Exclusion Criteria:

  • Presenting a contraindication to moderate physical activity
  • Deprived of their liberty by court or administrative decision
  • Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A control group

Patients will receive standard care, recommendations on physical activity.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5
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
Other Names:
  • Physical Activity level
Experimental: B experimental Group

1 or 2 physical activity sessions per week, either face-to-face or by videoconference at patient convenience: low-to-moderate intensity aerobic and anaerobic muscle-strengthening session and a 40-minute stretching/yoga session.

patients should wear the wristband continuously for 7 days prior to scheduled hospital visit T0, T1, T2, T3, T4, T5
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
Other Names:
  • Physical Activity level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedentary 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
Change between baseline and 3, 6, 12 months and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire
Time Frame: Change between baseline and 3, 6, 12 months and 18 months
Physical Activity level
Change between baseline and 3, 6, 12 months and 18 months
Quality of Life Questionnaire QLQ-C30
Time Frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life
Change between baseline and 3, 6, 12 months and 18 months
Head Neck (HN) 43 questionnaire
Time Frame: Change between baseline and 3, 6, 12 months and 18 months
Quality of Life
Change between baseline and 3, 6, 12 months and 18 months
Multidimensional Fatigue Inventory: MFI questionnaire
Time Frame: Change between baseline and 3 months
fatigue level
Change between baseline and 3 months
Big Five Inventory questionnaire
Time Frame: Change between baseline and 3 months
measure personality traits.
Change between baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Valence

Collaborators

Claude Bernard University

Investigators

  • Principal Investigator: Guillaume Guillaume, CH Valence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH-CHV-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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