Strength and Aerobic Training in Elderly Lymphoma Patients During Chemotherapy and Its Impact on Treatment Outcomes, Patients Functioning and Biological Markers of Aging
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|ClinicalTrials.gov Identifier: NCT03100175|
Recruitment Status : Unknown
Verified March 2017 by IULIANA VAXMAN, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Frailty, one of geriatric syndromes, is considered a major obstacle for recovery from physiological stress. Such stress is imposed on patients with cancer by virtue of the disease itself but even more so by the treatment. Moreover, malignancy and chemotherapy both cause accelerated loss of muscle mass, deconditioning, frailty and negative outcomes. Several studies showed that chemotherapy accelerates ageing.
Muscle mass reserve was found to be a major predictor of outcomes in patients treated with chemotherapy. Recently, several studies suggest that active muscle strength training during chemotherapy may decrease side effects, improves the ability to deliver intended doses of treatment and may even affect oncological outcomes.
In the proposed study we intend to assess the contribution of physical training to the well-being of chemotherapy treated older patients, assessed by molecular and physiological parameters.
We intend to recruit lymphoma patients above age of 70 and prospectively and randomly assign them to the intervention group (strength, aerobic and balance training during the chemotherapy) and control group (standard care with no special emphasis on physical activity during the treatment).
We will measure clinical outcomes such as treatment tolerance and effects as well as physiological outcomes (muscle strength and mass, elements activities of daily living) and laboratory markers of ageing such as DNA methylation, INK 4a expression, telomere length and serum levels of inteleukin 6, CRP among others.
Our hypothesis is that physical training will improve patients' ability to complete the treatment with fewer side effects, will provide them with better daily functioning and better muscle strength/function. We also hypothesize that the ageing process, as shown by laboratory senescence markers, will be attenuated in the intervention group.
|Condition or disease||Intervention/treatment||Phase|
|Strength Aerobic Training Elderly Lymphoma Sarcopenia Aging||Behavioral: physiotherapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Strength and Aerobic Training in Elderly Lymphoma Patients During Chemotherapy and Its Impact on Treatment Outcomes, Patients Functioning and Biological Markers of Ageing|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2019|
the patient will be scheduled for another appointment and taught a set of exercises including strength training for upper and lower limbs (with elastic bands and weights, rising up from chair and climbing stairs), fitness work out (brisk walking) and balance exercises, as recommended by senior sport programs.
strength training for upper and lower limbs fitness and balance work out
No Intervention: control
The control group will receive standard treatment and follow-up with no special emphasis on physical activity
- treatment tolerance [ Time Frame: 6 month ]treatment dose density
- muscle strength and mass [ Time Frame: 6 month ]evaluated by physiotherapists
- elements activities of daily living [ Time Frame: 6 month ]evaluated by physiotherapists
- DNA methylation [ Time Frame: 6 month ]blood tests
- INK 4a expression [ Time Frame: 6 month ]blood test
- telomere length [ Time Frame: 6 month ]blood tests
- serum levels of inteleukin 6 [ Time Frame: 6 month ]blood tests
- CRP [ Time Frame: 6 month ]blood tests