Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Rennes 2
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Une fatigue extrême
Une anémie symptomatique (hémoglobine ≤ 8 g/dl)
Un syndrome infectieux sévère en cours d'évolution
Une décompensation de pathologie cardio-pulmonaire
Trial population
Cachectic cancer patients: patients who have lost weight significantly in the last 6 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measuring energy balance
BehavioralThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Cancer cachectic patients1 intervention
Trial outcomes
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.
Time frame
During an exercise session in the 5th week of the programme.Secondary outcomes
1
Resting Energy Expenditure
Patients will be instructed to avoid moderate and vigorous physical activities for 24 hours prior to the measurement. Additionally, a 4-hour fast will be required, with no caffeine consumption during the last 4 hours and no tobacco use during the last 2.5 hours. During the measurement, patients will lie down for 30 minutes to reduce energy expenditure from previous physical activity. The measurement will then last 10 minutes once a stable state is reached (period during which oxygen consumption varies by less than 10%) (Rey, 2018). The room temperature will be maintained between 22 and 25°C to limit the effects of a cold environment on energy expenditure (Fullmer et al., 2015).
Time frame
During the initial consultation before starting the exercise programme2
Physical Behavior : Moderate Physical Activity
Moderate physical activity will be evaluated using the Steel HR (Withings®) activity monitors and the wGT3X+/GT3X+ accelerometers (ActiGraph®) worn at the waist (Smith et al., 2020), as well as a logbook documenting physical activities lasting longer than 10 minutes.
Time frame
Over 8 days during the exercise program3
Dietary Intake and Appetite
Dietary intake and appetite will be recorded daily in a nutrition journal, which is the reference method (Ortega et al., 2015), and using the SEFI® scale (Simple Evaluation of Food Intake) (Thibault et al., 2021). We will ensure a period of familiarization with the tool before the 7-day measurement period. The journal will allow us to assess appetite perception, meal frequency, quantities consumed, and any potential disruptions. These elements will help identify possible variations related to the completion of APA sessions.
Time frame
For 8 days during the exercise program4
Subjective Effort Perception
Subjective effort perception (RPE) will be assessed using the modified Borg scale ranging from 1 to 10. This scale helps to subjectively assess effort intensity, especially since certain antitumor treatments can alter heart rate responses to exercise.
Time frame
During Exercise Energy Expenditure assessmentSponsors and contacts
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Source ClinicalTrials.gov
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