Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396611
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-18
Brief Title:
Exercise as Intervention in Chronic Lymphocytic Leukemia
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
Randomised Controlled Clinical Trial of Exercise as Intervention in Chronic Lymphocytic Leukemia
Status:
RECRUITING
Status Verified Date:
2023-09
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:
ADRENALINE
Brief Summary:
PURPOSE The purpose of the study is to determine the effects of 16-weeks of exercise training as measured by aerobic capacity strength and physical function and body composition in patients with Chronic Lymphocytic Leukemia CLL
DESIGN Subjects will have confirmed treatment naïve CLL Subjects will be assigned to either a 16-week control group no supervised exercise or an intervention group of Resistance Training REx Before and after the 16-week protocol patients will undergo several tests including 1 a maximal cycle ergometer test 2 Body Composition 3 Muscle strength 4 physical activity levels 5 blood measures eg immune and inflammatory functions
DATA ANALYSES SAFETY ISSUES For outcomes group change differences from baseline to 16-weeks will be compared with ANCOVA Resistance training is a very safe exercise modality already studied in other cancer patients The regular use of vigorous-intensity exercise has been used extensively in exercise training It will always be respected for each subjects safety tolerance while challenging
HYPOTHESIS The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers
DESIGN Subjects will have confirmed treatment naïve CLL Subjects will be assigned to either a 16-week control group no supervised exercise or an intervention group of Resistance Training REx Before and after the 16-week protocol patients will undergo several tests including 1 a maximal cycle ergometer test 2 Body Composition 3 Muscle strength 4 physical activity levels 5 blood measures eg immune and inflammatory functions
DATA ANALYSES SAFETY ISSUES For outcomes group change differences from baseline to 16-weeks will be compared with ANCOVA Resistance training is a very safe exercise modality already studied in other cancer patients The regular use of vigorous-intensity exercise has been used extensively in exercise training It will always be respected for each subjects safety tolerance while challenging
HYPOTHESIS The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers
Detailed Description:
PURPOSE The purpose of the study is to determine the effects of 16-weeks of exercise training as measured by aerobic capacity strength and physical function and body composition in patients with CLL and without any prior treatment
DESIGN Subjects will have confirmed treatment naïve CLL Subjects will be assigned to either a 16-week control group no supervised exercise or an intervention group of Resistance Training REx Before and after the 16-week protocol patients will undergo several tests including 1 a Cardiopulmonary Exercise Test with Electrocardiogram CPETECG maximal cycle ergometer test 2 a dual-energy X-ray absorptiometry DEXA Body Composition test 3 a Muscle strength test with dynamometry 4 a characterization of physical activity PA levels with accelerometry and 5 blood measures eg immune and inflammatory functions The REx group will undertake a strength-based type of training with intensities near 80 of 1-Repetition Maximum 1-RM with individual supervision personal training approach
DATA ANALYSES SAFETY ISSUES For outcomes group change differences from baseline to 16-weeks will be compared with ANCOVA Resistance training is a very safe exercise modality already studied in other cancer patients The regular use of vigorous-intensity exercise has been used extensively in exercise training It will always be respected for each subjects safety tolerance while challenging
HYPOTHESIS The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters
DESIGN Subjects will have confirmed treatment naïve CLL Subjects will be assigned to either a 16-week control group no supervised exercise or an intervention group of Resistance Training REx Before and after the 16-week protocol patients will undergo several tests including 1 a Cardiopulmonary Exercise Test with Electrocardiogram CPETECG maximal cycle ergometer test 2 a dual-energy X-ray absorptiometry DEXA Body Composition test 3 a Muscle strength test with dynamometry 4 a characterization of physical activity PA levels with accelerometry and 5 blood measures eg immune and inflammatory functions The REx group will undertake a strength-based type of training with intensities near 80 of 1-Repetition Maximum 1-RM with individual supervision personal training approach
DATA ANALYSES SAFETY ISSUES For outcomes group change differences from baseline to 16-weeks will be compared with ANCOVA Resistance training is a very safe exercise modality already studied in other cancer patients The regular use of vigorous-intensity exercise has been used extensively in exercise training It will always be respected for each subjects safety tolerance while challenging
HYPOTHESIS The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters
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