Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651125
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS a PRELIMINARY STUDY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS a PRELIMINARY STUDY
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APACAVIR
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
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 andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None