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Trial Title:
Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment
NCT ID:
NCT06321744
Condition:
Cancer
Conditions: Keywords:
Physical exercise
cancer
hospitalization
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
adapted physical activity program (APA Program)
Description:
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.
Arm group label:
Adapted physical activity program (APA Program)
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.
Criteria for 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".
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06321744