Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323733
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-21
First Post:
2024-03-08
Brief Title:
Exercise Intervention for Patients With Cancer Cachexia Effects of a 12-week Program and One-year Follow-up
Sponsor:
Peyrachon Romane
Organization:
University of Rennes 2
Study Overview
Official Title:
Exercise Intervention for Patients With Cancer Cachexia Effects of a 12-week Supervised Program and One-year Follow-up of Patients and Cachexia-related Symptoms
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2CAPA
Brief Summary:
The prevalence of cancer with cachexia is rising sharply More than 80 of digestive cancer patients are affected by cancer cachexia Cachexia leads to weight loss and reduces quality of life QoL cancer treatment response and survival Exercise could counteract the deleterious effects of cachexia The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia including Health-Related QoL HRQoL fatigue appetite body composition physical fitness and physical activity levels Additionally it seeks to examine compliance with the exercise program identify barriers to regular exercise and determine how compliance influences physical and psychological effects Furthermore this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms
Methods This study will include 31 cancer patients with cachexia Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training Outcomes include HRQoL fatigue appetite anthropometric parameters physical performances and physical activity levels at baseline at the end of the 12-week exercise program and at 3- 6- and 12- months post-intervention
Methods This study will include 31 cancer patients with cachexia Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training Outcomes include HRQoL fatigue appetite anthropometric parameters physical performances and physical activity levels at baseline at the end of the 12-week exercise program and at 3- 6- and 12- months post-intervention
Detailed Description:
Study objectives and design
The 2CAPA study will aim to assess the efficacy of a supervised 12-week APA program on cachexia symptoms HRQoL global QoL fatigue physical functioning appetite and pain cancer-related fatigue appetite body composition weight lean mass fat mass appetite physical condition endurance strength balance and physical activity and sedentary levels The secondary aim will be to assess the compliance to exercise program and barriers that could affect compliance and to explore how compliance may impact the magnitude of the observed effects The third objective will be to determine the maintenance of physical activity levels and the effects of exercise for 1 year follow-up at the 3-months 6-months and 12-mon
ths follow-ups assessments on cachexia symptoms In summary this study aims to assess the effectiveness of a 12-week exercise program on various parameters affected by cancer-related cachexia and identify barriers to regular participation to exercise program Patient behavior and outcomes will then be assessed during a one-year post-program follow-up
The 2CAPA study is a prospective single-arm study conducted in a sport and medicine center The study is promoted by the University of Rennes 2 Rennes France
Recruitment
Patients can join the program spontaneously or after receiving information at the hospital At the hospital patients diagnosed with cancer cachexia will undergo eligibility screening by clinicians within the Digestive Tract Diseases department of Rennes University Hospital CHU Rennes France Clinicians will identify suitable participants and refer them to the sports-medical center SPORMED Rennes France located outside the hospital where the sessions will take place A practice setting outside the hospital can encourage engagement and enable the study of the effects of exercise by being as close as possible to peoples real-life conditions The physiotherapist at the sports-medical center will provide participants with information about the possibility and benefits of exercise Additionally the physiotherapist will guide patients to the sports-medical center SPORMED Rennes France where the sessions will take place Patients enrolled in the exercise program will then receive both oral and written information about the trial All participants will be required to sign and provide an informed consent form
Intervention
Exercise intervention
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 Patients will have the flexibility to choose their session time between 1130 am and 4 pm and each session will last 1 hour under the supervision of physiotherapists The program will include both aerobic and resistance exercises The program will adhere to the principle of autoregulation allowing for a reduction in exercise intensity andor duration when treatment-related side effects will be heightened Patients will be encouraged to maintain the prescribed exercise intensity and duration if treatment-related side effects will be manageable
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 Heart rate will be monitored using a pulse oximeter Participants will report their rate of perceived exertion during endurance training using a 5-point scale very easy easy moderate difficult very difficult Session intensity will be determined based on the HRR which will be calculated with the theoretical maximal heart rate HR maximal and resting heart rate HR rest of the patient with adjustments made according to the patients feedback and treatment-related side effects
Subsequently resistance training will begin with a mobility warm-up followed by exercises involving body weight free weight elastics swissball etc The protocol for resistance training is described in the Supplemental Material Patients will perform 2 to 4 sets per exercise and 8 to 14 repetitions
Outcomes will be assessed at baseline at the initiation of the program post-intervention at the end of the program and at 3 6 and 12 months of follow-up All assessments will be conducted by an exercise physiologist Demographics and treatment and diagnosis characteristics were collected at baseline during a short interview
The 2CAPA study will aim to assess the efficacy of a supervised 12-week APA program on cachexia symptoms HRQoL global QoL fatigue physical functioning appetite and pain cancer-related fatigue appetite body composition weight lean mass fat mass appetite physical condition endurance strength balance and physical activity and sedentary levels The secondary aim will be to assess the compliance to exercise program and barriers that could affect compliance and to explore how compliance may impact the magnitude of the observed effects The third objective will be to determine the maintenance of physical activity levels and the effects of exercise for 1 year follow-up at the 3-months 6-months and 12-mon
ths follow-ups assessments on cachexia symptoms In summary this study aims to assess the effectiveness of a 12-week exercise program on various parameters affected by cancer-related cachexia and identify barriers to regular participation to exercise program Patient behavior and outcomes will then be assessed during a one-year post-program follow-up
The 2CAPA study is a prospective single-arm study conducted in a sport and medicine center The study is promoted by the University of Rennes 2 Rennes France
Recruitment
Patients can join the program spontaneously or after receiving information at the hospital At the hospital patients diagnosed with cancer cachexia will undergo eligibility screening by clinicians within the Digestive Tract Diseases department of Rennes University Hospital CHU Rennes France Clinicians will identify suitable participants and refer them to the sports-medical center SPORMED Rennes France located outside the hospital where the sessions will take place A practice setting outside the hospital can encourage engagement and enable the study of the effects of exercise by being as close as possible to peoples real-life conditions The physiotherapist at the sports-medical center will provide participants with information about the possibility and benefits of exercise Additionally the physiotherapist will guide patients to the sports-medical center SPORMED Rennes France where the sessions will take place Patients enrolled in the exercise program will then receive both oral and written information about the trial All participants will be required to sign and provide an informed consent form
Intervention
Exercise intervention
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 Patients will have the flexibility to choose their session time between 1130 am and 4 pm and each session will last 1 hour under the supervision of physiotherapists The program will include both aerobic and resistance exercises The program will adhere to the principle of autoregulation allowing for a reduction in exercise intensity andor duration when treatment-related side effects will be heightened Patients will be encouraged to maintain the prescribed exercise intensity and duration if treatment-related side effects will be manageable
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 Heart rate will be monitored using a pulse oximeter Participants will report their rate of perceived exertion during endurance training using a 5-point scale very easy easy moderate difficult very difficult Session intensity will be determined based on the HRR which will be calculated with the theoretical maximal heart rate HR maximal and resting heart rate HR rest of the patient with adjustments made according to the patients feedback and treatment-related side effects
Subsequently resistance training will begin with a mobility warm-up followed by exercises involving body weight free weight elastics swissball etc The protocol for resistance training is described in the Supplemental Material Patients will perform 2 to 4 sets per exercise and 8 to 14 repetitions
Outcomes will be assessed at baseline at the initiation of the program post-intervention at the end of the program and at 3 6 and 12 months of follow-up All assessments will be conducted by an exercise physiologist Demographics and treatment and diagnosis characteristics were collected at baseline during a short interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None