Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment

NCT ID: NCT06321744

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

Brief Summary

This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.

It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adapted physical activity program (APA Program)

An intervention (APA program) will be offered to patients hospitalized in the conventional hospitalization department of the medical oncology department.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.

Group Type: EXPERIMENTAL

adapted physical activity program (APA Program)

Intervention Type: OTHER

Content of the APA program:

• Strengthening of the lower limbs: Exercises alternating different regimes of muscular contractions (eccentric, concentric and isometric), with the use of elastics, balls or even body weight. These exercises will mainly work the quadriceps and hamstrings.
• Upper limb strengthening: Exercises focused on eccentric and concentric contraction regimes, in a global movement approach (as opposed to a segmental approach), with the use of elastics, dumbbells, weighted balls, etc. These exercises will work the muscles of the biceps, triceps, pectorals, deltoids and lats.
• Walking: In the room and/or in the corridor, with technical assistance (cane/walker, etc.) or human work
• Balance and proprioception: Balance work in a bi- and uni-pedal situation, statically and dynamically (eyes open and closed) will be offered with the use of proprioception boards and/or mats combining if possible work in dual task.

Interventions

adapted physical activity program (APA Program)

Content of the APA program:

• Strengthening of the lower limbs: Exercises alternating different regimes of muscular contractions (eccentric, concentric and isometric), with the use of elastics, balls or even body weight. These exercises will mainly work the quadriceps and hamstrings.
• Upper limb strengthening: Exercises focused on eccentric and concentric contraction regimes, in a global movement approach (as opposed to a segmental approach), with the use of elastics, dumbbells, weighted balls, etc. These exercises will work the muscles of the biceps, triceps, pectorals, deltoids and lats.
• Walking: In the room and/or in the corridor, with technical assistance (cane/walker, etc.) or human work
• Balance and proprioception: Balance work in a bi- and uni-pedal situation, statically and dynamically (eyes open and closed) will be offered with the use of proprioception boards and/or mats combining if possible work in dual task.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Man or woman aged 18 and over (no age limit)
• Patient followed for cancer,
• Patients with no medical contraindication to adapted physical activity (certificate)
• Patient with a performance index status less than 4
• Patient hospitalized in the conventional medical oncology hospitalization department of Besançon University Hospital.
• Patient not opposed to participating in the study
• Patient affiliated to a French social security scheme or beneficiary of such a scheme.
• For women: menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, patches contraceptives)
• Length of hospitalization estimated at at least 7 days (main objective) and with the patient's objective of returning home or to SSR in the long term

Exclusion Criteria

• Patient with an absolute medical contraindication to adapted physical activity
• Patient with inability to understand instructions and complete questionnaires.
• Patient with a performance index status of 4
• Patient with legal incapacity or limited legal capacity
• Patient unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
• Patient without health insurance
• Pregnant woman
• Patient being in the exclusion period of another study or provided for by the "national volunteer file".

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quentin JACQUINOT, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Central Contacts

Quentin JACQUINOT, Dr

Role: CONTACT

qjacquinot@irfc-fc.fr

0370632058

Other Identifiers

2023/825

Identifier Type: -

Identifier Source: org_study_id