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

Condition(s) studied

Investigational drug(s) / intervention(s)

Measuring energy balance: 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.

Study summary

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. 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.

If you take part in the EMC2APA study, we will ask you to measure your gas exchange at rest (60 minutes) and during the aerobic part of one of your physical activity sessions. You will perform the effort traditionally targeted during the sessions (constant moderate intensity (60% of your Reserve Heart Rate, equivalent to a perception of the difficulty of the effort of 5-6/10) while your gas exchanges will be measured using a portable, non-invasive measuring device (K5, COSMED®). You will also be fitted with an accelerometric wristwatch.

In addition to the gas exchange measurements that will take place in the SPORMED structure, we will ask you to fill in a logbook tracking your daily physical activity and your daily food intake. You will also be asked to wear an accelerometer in a belt attached to your hip for 7 days.

Participation in this study is voluntary. There are no restrictions during the protocol.

Eligibility

Primary outcome measure(s)

• Exercise energy expenditure — During an exercise session in the 5th week of the programme.
  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.

Trial sites (1)

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