Cancer Cachexia
Conditions
Keywords
Cancer Cachexia, Exercise, Adapted Physical Activity, Resistance training, Endurance training, Body composition
Brief summary
The goal of this project is to observe the benefits induced by physical activity during a supervised adapted physical activity program at SPORMED. Methodology: By agreeing to participate in this study, participation in a supervised adapted physical activity (APA) program at SPORMED and undergoing a series of evaluations will be required. At the start of the adapted physical activity program (T0), two APA sessions per week will be carried out for eight weeks. These group sessions, involving four participants, last 1 hour and are divided into 30 minutes of aerobic work on an ergometer followed by 30 minutes of muscle strengthening of the four limbs and core exercises, with or without small equipment. There is also the option to add a 45-minute balneotherapy session once a week, if desired and no contraindications are present. At the end of the eight weeks (T1), a follow-up phase begins, consisting of one APA session per week for another eight weeks. The session will be identical to the previously described sessions and can also be complemented by a balneotherapy session. The APA program will conclude after these 12 weeks (T2). A total of 24 indoor sessions will be offered, which can be supplemented by 12 balneotherapy sessions. Attendance at the sessions will be recorded. Additionally, a series of evaluations will take place at T0, T1, and T2. These include physical and anthropometric assessments at SPORMED lasting approximately 30 minutes. They involve weight and body composition evaluation (2 minutes), height measurement (1 minute), waist and hip circumference measurements using a tape measure (2 minutes). Next, an upper limb strength test will be conducted, involving three maximal contractions during a handgrip test with 30-second rest intervals (2 minutes), followed by a lower limb strength test, which involves performing as many sit-to-stand repetitions from a chair with a backrest and without armrests as possible in 30 seconds (30 seconds). Then, a balance test, including bipodal and unipodal stance (30 seconds on both feet, followed by each foot individually), will be performed, and finally, a 6-minute walking test, during which the longest possible distance must be covered (without running) in 6 minutes (6 minutes, with the option to stop if necessary). Additionally, four self-assessment questionnaires on quality of life, fatigue, physical activity level, and food consumption must be completed at home (about 20 to 30 minutes).
Detailed description
Patient volunteers were referred to Spormed sports medicine center by an oncologist and/or general practitioner. To be eligible for the study, participants had to be over 18 years old and have a diagnosis of cachexia-inducing cancer. Metastasis could be present or not. Participants could either be undergoing treatment or have completed treatment within the last year. They had to be able to participate in physical activity (PA). Additionally, registration with the French health insurance system and having French as the primary language were required. Those who could not report weight changes in the last 6 months, individuals with disabilities preventing them from understanding study instructions, and those with medical contraindications for PA were excluded from the study. Participants were assigned to the cachectic group if classified in categories 3 or 4 of the Martin and colleagues classification. This classification is based on two criteria: percentage of weight loss in the past six months and body mass index. Participants classified as grades 0, 1, or 2 were included in the non-cachectic group. The non-cachectic group was matched to the cachectic group based on sex, age, and number of PA sessions completed. The aim was to verify whether the recognized effects of APA in non-cachectic individuals could be transferred to cachectic participants, with matching on the compliance variable to avoid an effect related to the amount of practice. Matching tumor type was not possible, as certain tumors are almost exclusively cachectizing. Supervised Physical Activity Intervention: The supervised PA intervention consisted of two sessions per week over a span of 12 weeks. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.
Interventions
OTHERAdapted Physical Activity
Patients in the Adapted Physical Activity arm realized a 12-weeks supervised exercise program. The supervised PA intervention consisted of two sessions per week. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.
Sponsors
University of Rennes 2
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Over 18 years * Diagnosis of cancer cachexia * Able to participate in exercise program * Registered with the French health insurance system * Understanding and speaking French
Exclusion criteria
* Medical contraindications for exercise * No report of weight changes in the last 6 months * Disabilities to understand the study instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition rate | Through study completion, an average of 3 months | Attrition rate was the number of patients who completed the baseline and follow-up assessments versus the number of patients who completed initial assessments and started the program |
| Compliance rate | Through study completion, an average of 3 months | Compliance rate was the number of sessions completed out of the number of sessions prescribed |
| Serious adverse events | Through study completion, an average of 3 months | Serious adverse events occurring during the exercise program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean mass | Through study completion, an average of 3 months | Lean mass (kg) was assessed using bioelectrical impedance analysis (Tanita, DC-360). |
| Physical activity level | Through study completion, an average of 3 months | PA level was assessed using the International Physical Activity questionnaire Short-Form (IPAQ-SF). This 7 items questionnaire covers overall PA, broken down into intense, moderate and walking activities, and the level of sedentary lifestyle over the past seven days. |
| Functional aerobic capacity | Through study completion, an average of 3 months | Functional aerobic capacity was measured using the 6-minute walk test. Patients were instructed to walk back and forth along a 20-meter corridor to cover the greatest distance at constant speed. After 6 minutes, the distance walked was recorded in meters. |
| Nutritional status | Through study completion, an average of 3 months | Food intake was evaluated using the analog scale Simple Evaluation of Food Intake (SEFI®) |
| Grip strength | Through study completion, an average of 3 months | Grip strength was measured using a Hand Grip Digital Dynamometer (Takei 5401 Hand Grip Digital Dynamometer). The test was performed with patients in a sitting position, with both feet touching the ground, hand holding the dynamometer, elbow flexed at 90° and shoulder adducted. The participant were instructed to squeeze the handle with maximum force for 3 sec. The test was repeated three times, with 30 seconds of recovery time between each effort. The highest value of the three repetition was retained in kilograms (kg) for each hand. |
| Balance ability | Through study completion, an average of 3 months | Static balance ability was evaluated using the single-leg stance test. The time the patient-maintained balance on one leg with eyes open was recorded (maximum 30 sec). |
| Perceived Fatigue | Through study completion, an average of 3 months | Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI). The questionnaire comprises 20 statements in which the patient positions himself on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). |
| Lower limb strength | Through study completion, an average of 3 months | Proximal lower limb strength was evaluated using a 30-second (sec) chair sit-to-stand test. Patients were instructed to rise from a seated position to a standing position and return to seating, without assistance and without using their arms, as many times as possible within 30 sec. The number of complete stands within this period was recorded. |
| Body weight | Through study completion, an average of 3 months | Body weight (kg) |
| Fat mass | Through study completion, an average of 3 months | Fat mass was assessed using bioelectrical impedance analysis |
Countries
France
Outcome results
None listed