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

NCT06321744 | Unknown

• 1 other identifier: 2023/825
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

Physical exercise; cancer; hospitalization

Outcome Measures

Primary Outcomes (1)

• Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment

  The main objective of the study is to validate that the proportion of patients having completed, from inclusion (D0), at least three supervised APA sessions of a minimum duration of 15 minutes, during the first 7 consecutive days of his hospitalization (P) is beyond a threshold considered uninteresting of 50% (P0) To test the following hypotheses: H0: a compliant patient rate \<= 50% is uninteresting (P\<=P0) H1: a compliant patient rate \> 80% is expected (P\>P1) With an A'Hern type design, a one-sided alpha risk of 2.5% and a power of 90%, it is required to include 28 evaluable patients in the study to test H0 vs H1. Considering a rate of unevaluable patients of 10% it will be necessary to include 32 patients. Hypothesis H0 will be rejected if 20 (71.4%) or more than 20 patients out of the first 28 evaluable are compliant.

  7 days after inclusion

Secondary Outcomes (12)

• Describe the evolution of body composition measured by impedancemetry

  At inclusion (day 1) and at the study completion, an average of 15 days

• Describe the evolution of physical parameters functional capacities

  At inclusion (day 1) and at the study completion, an average of 15 days

• Describe the evolution of autonomy in daily life activities

  At inclusion (day 1) and at the study completion, an average of 15 days

• Describe the evolution of muscular strength

  At inclusion (day 1) and at the study completion, an average of 15 days

• Describe the evolution of the quality of life

  At inclusion (day 1) and at the study completion, an average of 15 days

Study Arms (1)

Adapted physical activity program (APA Program)

EXPERIMENTAL

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.

Other: adapted physical activity program (APA Program)

Interventions

adapted physical activity program (APA Program) 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.

Adapted physical activity program (APA Program)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Quentin JACQUINOT, Dr

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quentin JACQUINOT, Dr

CONTACT

0370632058; qjacquinot@irfc-fc.fr

Study Design

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

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 20, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share