Clinical trial · Interventional
Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adapted physical activity program (APA Program) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adapted physical activity program (APA Program)
- description
- 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.
- interventionNames
- Other: adapted physical activity program (APA Program)
Primary outcomes (1)
- measure
- 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
- timeFrame
- 7 days after inclusion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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".
References
Publications (0)
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