Clinical trial NCT06651125: EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS: a PRELIMINARY STUDY
Official title: EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS: a PRELIMINARY STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Cachexia
Keywords: Cancer Cachexia
Exercise
Adapted Physical Activity
Resistance training
Endurance training
Body composition
Lead sponsor: University of Rennes 2
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attrition rate
timeFrame: Through study completion, an average of 3 months
measure: Compliance rate
timeFrame: Through study completion, an average of 3 months
measure: Serious adverse events
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Nutritional status
timeFrame: Through study completion, an average of 3 months
measure: Body weight
timeFrame: Through study completion, an average of 3 months
measure: Fat mass
timeFrame: Through study completion, an average of 3 months
measure: Lean mass
timeFrame: Through study completion, an average of 3 months
measure: Physical activity level
timeFrame: Through study completion, an average of 3 months
measure: Functional aerobic capacity
timeFrame: Through study completion, an average of 3 months
measure: Lower limb strength
timeFrame: Through study completion, an average of 3 months
measure: Grip strength
timeFrame: Through study completion, an average of 3 months
measure: Balance ability
timeFrame: Through study completion, an average of 3 months
measure: Perceived Fatigue
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: SPORMED
state: Bretagne
Study officials:
References: