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

NCT06184880 | Recruiting

• 1 other identifier: RIPH-CHV-14
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Aerodigestive Tract Cancer; Head and Neck Cancer

Keywords

Physical Activity; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• sedentary level

  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 Outcomes (5)

• International Physical Activity Questionnaire

  Change between baseline and 3, 6, 12 months and 18 months

• Quality of Life Questionnaire QLQ-C30

  Change between baseline and 3, 6, 12 months and 18 months

• Head Neck (HN) 43 questionnaire

  Change between baseline and 3, 6, 12 months and 18 months

• Multidimensional Fatigue Inventory: MFI questionnaire

  Change between baseline and 3 months

• Big Five Inventory questionnaire

  Change between baseline and 3 months

Study Arms (2)

A control group

ACTIVE COMPARATOR

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; Other: Sedentary

B experimental Group

EXPERIMENTAL

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; Other: Sedentary

Interventions

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,

A control group; B experimental Group

Sedentary OTHER

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

Also known as: Physical Activity level

A control group; B experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Centre Hospitalier de Valence: lead
• Claude Bernard University: collaborator

Study Sites (1)

Ch Valence

Valence, 26000, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior

Study Officials

• Guillaume Guillaume

  CH VALENCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Buiret

CONTACT

+33475752555; gbuiret@ch-valence.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, open label, controlled, monocentric, study

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 28, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)