Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program
NCT ID: NCT05099211
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-07-31
2025-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Patients muscle strengthening
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
Intermediate Evaluation 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Final post-training evaluation 4
Tests identical to evaluation 1 + TM6
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.
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.
Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
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
Aerobic Training Patients
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
Intermediate Evaluation 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Final post-training evaluation 4
Tests identical to evaluation 1 + TM6
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.
Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
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.
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
Healthy patients
Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
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
Interventions
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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
Intermediate Evaluation 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Final post-training evaluation 4
Tests identical to evaluation 1 + TM6
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.
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.
Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
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.
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
Eligibility Criteria
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Inclusion Criteria
* with a first diagnosis of colon cancer, regardless of TNM stage
* to undergo a scheduled excision surgery (laparoscopic colectomy or laparoscopy)
* with WHO stage \< 1 to the inclusion visit
* having given their written consent
* living close to the participating center (\<50 km)
* ability to understand instructions
Criteria for inclusion of healthy subjects :
* Adult who is \< 80 years old
* matched by gender, age and BMI to a patient
* with WHO stage \< 1 at visit V1
* no medical contraindications to the program
* having given written consent
Exclusion Criteria
* Protected Adult
* Person not affiliated to national health insurance
* Pregnant or breastfeeding woman
* uncontrolled hypertension
* Suffers from unstable diabetes of any type
* Suffers from heart disease. Pre-surgical VO2 test will confirm authorization.
* Affected by any condition likely to complicate the performance of physical activity (neurological, psychiatric, neuromuscular disorders, severe osteoporosis)
* Patient who received neo-adjuvant chemotherapy
\- Patient with rectal cancer or other evolving cancer
* Subject has had cancer in the last 5 years
* Subject with a high level of physical activity according to the IPAQ questionnaire
Criteria for exclusion of patients and healthy subjects for biopsy:
* Person with keloidosis
* Person with bleeding disorders, and/or on anticoagulant and antiaggregant medication
* hypersensitivity to lidocaine
* Patient with a WHO stage \> 1 at the V2 visit
* Presence of an ostomy (complicates PA practice)
* absence of post-operative chemotherapy treatment
* subject with a WHO stage \> 1 at the V2 visit
18 Years
80 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COTTET CHU Dijon 2018
Identifier Type: -
Identifier Source: org_study_id
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