Trials / Unknown
UnknownNCT05099211
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life. Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it. Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass. Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Muscle biopsies | Optional In pre-training: Biopsy performed during the digestive surgery procedure Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department. |
| OTHER | Muscle Strengthening | 3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions. |
| BIOLOGICAL | Blood and urine samples | fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls |
| OTHER | Aerobic Training | 3 sessions per week for 18 weeks. Duration: 1 hour Training on a "classic" pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities. |
| OTHER | Evaluation 1 pre-surgery | Carried out at least 15 days before surgery 1. st visit: * Nutritional assessment * Body composition * Psychometric tests of quality of life + IPAQ Test * VO2pic 2. nd visit: * Neuromuscular tests * Functional tests |
| OTHER | Evaluation 2 post-surgery | 1. st visit: * Body composition * Nutritional assessment * Psychometric tests of quality of life 2. nd visit: * neuromuscular tests * Functional tests * Familiarization with training equipment if patient participates in re-training |
| OTHER | Intermediate Evaluation 3 | performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6 |
| OTHER | Final post-training evaluation 4 | Tests identical to evaluation 1 + TM6 |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2021-10-29
- Last updated
- 2022-06-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05099211. Inclusion in this directory is not an endorsement.