None listed
Conditions
Brief summary
The EXEL study will look at the effects of combining a structured exercise program with chemotherapy in patients with lymphoma to see whether adding exercise to a chemotherapy treatment schedule can be accomplished safely and practically. Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years and have a biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin. You should also be recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care which includes general health education materials regarding nutrition and physical activity, in conjunction with their prescribed chemotherapy/radiotherapy treatment. Participants in the other group will undergo a structured exercise program. All participants will be asked to complete a number of questionnaires at the beginning of the study, then at the 6 week, 12 week, 6 month and 12 month (completion of the study) time points. This information will help us evaluate whether regular supervised exercise in addition to chemotherapy improves the quality of life and sense of wellbeing during and after chemotherapy. This study will also look at whether adding an exercise program to chemotherapy helps increase the ability of patients to receive the prescribed dose of chemotherapy treatment in the required treatment time frame. A number of study procedures will be performed when you start your participation in the study. These include: Health status assessment – your doctor will collect clinical information about your medical history and your current level of exercise. You will also be asked to complete a number of written questionnaires that look at different aspects of your wellbeing and quality of life. This will take approximately 15 minutes. Physical examination – your blood pressure and heart rate will be checked. Your weight, height and waistline will also be measured. You will also perform three short walking, strength and balance tests. This will take approximately 15 minutes to complete. Blood tests – this is to check the levels of different blood cells and important vitamins and minerals in your body. Your liver and kidney function, markers of inflammation and lymphoma activity and levels of immune proteins will also be assessed. This test is done only at the beginning of the study. ECG (electrocardiogram) – this test records the electrical activity of your heart to ensure that you have a normal heart rhythm. This procedure takes about 15 minutes and is painless. This test is done only at the beginning of the study. Bone mineral density assessment (DEXA scan) – this is a specialised X-ray scan that tests overall bone strength and risk of fractures. X-rays of two different strengths are passed through the tissues of the body and depending on the density of the tissues. This scan takes 5-10 minutes to complete and is painless. This test is done at the beginning and the end of the study. The exercise program includes: Aerobic Aerobic exercises primarily consist of treadmill or upright/recumbent cycling. Aerobic activities are usually 5 – 15 min duration depending on Rating of Perceived Exertion (RPE) or fatigue levels. Intensity is gradually progressed i.e. speed or resistance to support cardio- respiratory improvements. Rowing or Elliptical trainers are also available and may be considered as an alternative. Resistance Training All major muscle groups are exercised and we utilise pin loaded weights machines to ensure safe and effective technique. The participants commence at 75% or their 1 RM score and the resistance is gradually increased and capacity/strength improves. Typically 2 – 3 sets or 10 – 12 repetitions, although can be modified by Exercise Physiologist to suit individual.
Interventions
Participants undergo an initial assessment where an accredited exercise physiologist designs an individually tailored exercise program. Sessions are conducted twice weekly for a total of 20 sessions. All sessions are conducted within a group setting with a maximum number of 6 individuals under the guidance and supervision of an accredited exercise physiologist.
The exercise program will include both aerobic and resistance training. Although prior observational exercise intervention studies have
Participants undergo an initial assessment where an accredited exercise physiologist designs an individually tailored exercise program. Sessions are conducted twice weekly for a total of 20 sessions. All sessions are conducted within a group setting with a maximum number of 6 individuals under the guidance and supervision of an accredited exercise physiologist. The exercise program will include both aerobic and resistance training. Although prior observational exercise intervention studies have focused on aerobic physical activity alone, our study will involve a combination of both aerobic and resistance training as the latter has been shown to have a positive effect on the performance of tasks required for everyday function. Initial sessions will be of 20 minutes duration with 5-minute warm up and cool down periods. The sessions are classified as light in intensity with an aim to achieve 40-50% of heart rate reserve or a rate of perceived exertion (RPE) of 10-12. Subsequent sessions will gradually increase in duration (by 5 to 10 minutes) and intensity to a maximum of 45 minutes, with a 40:60 ratio of aerobic training to resistance training. It is recognized that some participants may achieve the training goals earlier but progression will adhere strictly to the American College of Sports Medicine Guidelines. Aerobic Aerobic exercises primarily consist of treadmill or upright/recumbent cycling. Aerobic activities are usually 5 – 15 min duration depending on Rating of Perceived Exertion (RPE) or fatigue levels. Intensity is gradually progressed i.e. speed or resistance to support cardio- respiratory improvements. Rowing or Elliptical trainers are also available and may be considered as an alternative. Resistance Training All major muscle groups are exercised and we utilise pin loaded weights machines to ensure safe and effective technique. The participants commence at 75% or their 1 RM score and the resistance is gradually increased and capacity/strength improves. Typically 2 – 3 sets or 10 – 12 repetitions, although can be modified by Exercise Physiologist to suit individual.
Sponsors
Dr Fernando Roncolato
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with all of the following criteria will be eligible for enrolment: a) Aged between 18 and 80 years with biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin. b) Recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent. c) Need to have at least half of their recommended number of chemotherapy treatment cycles remaining. d) ECOG level 0-2 with adequate cardio-respiratory and musculoskeletal function to participate in a regular exercise program as determined by the consultant physician/investigator. e) Ability to read and understand the Patient Information Document and Consent Form with provision of verbal and written consent. Willingness and ability to comply with the specified intervention protocol, follow-up visits and all necessary investigations.
Exclusion criteria
Patients with any of the following criteria are not eligible for enrolment: a) Recommended to either observation or chemotherapy with palliative intent. b) Psychiatric disorders which impair ability to give verbal and written consent. c) ECOG level 3-4
Outcome results
None listed