Clinical Trials Directory

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

TypeNameDescription
PROCEDUREMuscle biopsiesOptional 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.
OTHERMuscle Strengthening3 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.
BIOLOGICALBlood and urine samplesfasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
OTHERAerobic Training3 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.
OTHEREvaluation 1 pre-surgeryCarried 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
OTHEREvaluation 2 post-surgery1. 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
OTHERIntermediate Evaluation 3performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
OTHERFinal post-training evaluation 4Tests 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.