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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: adapted physical activity program (APA Program)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quentin JACQUINOT, Dr; Phone Number: 0370632058; Email: qjacquinot@irfc-fc.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the evolution of body composition measured by impedancemetry	fat-free mass index and muscle mass,; body protein content,; metabolic activity index	At inclusion (day 1) and at the study completion, an average of 15 days
Describe the evolution of physical parameters functional capacities	- Score of Short Physical Performance Battery Test (Score of 0 =Faible performance to 12= Haute performance)	At inclusion (day 1) and at the study completion, an average of 15 days
Describe the evolution of autonomy in daily life activities	IADL Questionnaire IADL score 0 to 4; IADL score = 0: dependent; IADL score = 4 autonomous	At inclusion (day 1) and at the study completion, an average of 15 days
Describe the evolution of muscular strength	Handgrip :results in kilograms	At inclusion (day 1) and at the study completion, an average of 15 days
Describe the evolution of the quality of life	QLQ-C30 questionnaire All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	At inclusion (day 1) and at the study completion, an average of 15 days
Describe the evolution of motivation to practice physical activity	Questionnaire BREQ-2 The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me)	At inclusion (day 1) and at the study completion, an average of 15 days
Tolerance with the APA program on perception of effort	Perception of effort with te Borg scale CR10. Scale of 0 (No exertion at all) to 10 (representing an extreme intensity of activity)	immediately after each intervention session
Tolerance with the APA program on pain and fatigue	Visual analog scale (0 = no pain and 10 = very severe pain)	Immediately before and after each intervention session
Tolerance with the APA program on fatigue	Visual analog scale (0 = no fatigue and 10 = very severe fatigue)	Immediately before and after each intervention session
Compliance with the APA program	Number of sessions carried out out of the number planned	at the study completion, an average of 15 days
Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals		at the study completion, an average of 15 days
Patient satisfaction	Likert scale (0= unsatisfiedt o 5 =very satisfied)	at the study completion, an average of 15 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Quentin JACQUINOT, Dr, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cancer; Physical exercise; hospitalization
• Other Study ID Numbers: 2023/825

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