Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity

NCT06645067 | Not Yet Recruiting

• 1 other identifier: 2024-035
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.OBJECTIVE OF THE STUDY The study consists of evaluating resting energy expenditure (REE) and that induced by adapted physical activity (APA) in cachectic patients, compared with those predicted by equations and those of non-cachectic cancer patients. We will also seek to identify potential compensations in the level of Physical Activity (PA) and dietary intake during one week of the PA programme.
2. 2.CONDUCT OF THE STUDY Taking part in this study will in no way affect your treatment at SPORMED; you will undergo the same assessments and carry out the PAA programme in the same way. As a reminder, your treatment at SPORMED consists of an initial assessment session, a 12-week ABS programme and a final assessment session.

Conditions

Cancer Cachexia (CC); Exercise; Energy Regulation

Keywords

Cancer Cachexia; Exercise; Endurance; Energy Expenditure; Food Intake; Physical activity

Outcome Measures

Primary Outcomes (1)

• Exercise energy expenditure

  The measurement will be carried out on a treadmill ergometer and/or stationary bike. The exercise energy expenditure measurement will include a 7-minute warm-up with incremental intensity to reach a work level representing moderate effort in terms of RPE (5/10) or heart rate (60% of maximum heart rate), followed by 15 minutes of constant moderate-intensity exercise. A 2-minute recovery period will be added at the end to avoid abrupt physiological changes. The exercise energy expenditure measurement will take place after a period of familiarization with the cycle ergometer to minimize disturbances caused by stress or technical inefficiency.

  During an exercise session in the 5th week of the programme.

Secondary Outcomes (10)

• Resting Energy Expenditure

  During the initial consultation before starting the exercise programme

• Physical Behavior : Moderate Physical Activity

  Over 8 days during the exercise program

• Dietary Intake and Appetite

  For 8 days during the exercise program

• Subjective Effort Perception

  During Exercise Energy Expenditure assessment

• Heart Rate

  During Exercise Energy Expenditure assessment

Study Arms (1)

Cancer cachectic patients

This group is made up of patients suffering from cancer cachexia who take part in an APA programme at the medical-sports centre. These are patients who agree to have their energy expenditure measured at rest and during sub-maximal effort, as well as their level of physical activity and diet monitored for 7 days.

Behavioral: Measuring energy balance

Interventions

Measuring energy balance BEHAVIORAL

The exercise intervention will consist of a personalized and supervised program lasting 12 weeks with two sessions per week, held on Tuesdays and Thursdays at the Sports and Medicine Center SPORMED in Rennes, France. Each session will combine endurance and resistance training, commencing with a 6-minute cardiovascular warm-up on ergometers (cycling ergometer or treadmill). This will be followed by 20 minutes at moderate intensity (60-70% of Heart Rate Reserve (HRR)), concluding with a 2-minute recovery period at light intensity. We will measure the resting ED at the start of the programme and the ED during moderate aerobic exercise in the 5th week of APA.

Cancer cachectic patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cachectic cancer patients: patients who have lost weight significantly in the last 6 months.

You may qualify if:

• Be at least 18 years old.
• Have understood the objectives of the study.
• Have read and signed the consent form.
• Be affiliated with a social security system.
• Currently undergoing cancer treatment.

You may not qualify if:

• Une fatigue extrême
• Une anémie symptomatique (hémoglobine ≤ 8 g/dl)
• Un syndrome infectieux sévère en cours d'évolution
• Une décompensation de pathologie cardio-pulmonaire
• La présence de lésions osseuses lytiques du rachis ou des os longs (la contre-indication concerne la mobilisation du membre atteint)
• Une intolérance au port du masque de l'appareil K5 (Cosmed)

Sponsors & Collaborators

• University of Rennes 2: lead

Study Sites (1)

SPORMED

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Romane Peyrachon, MD

CONTACT

33 6 09 37 92 45; romane.peyrachon@ens-rennes.fr

Amélie Rébillard, PhD

CONTACT

33 2 90 09 15 87; amelie.rebillard@univ-rennes2.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: February 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

FR (1)