This is an interventional, non-pharmacologic, randomized controlled study evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. Patients will be randomized 1:1 in two arms: arm A (interventional) and arm B (control). The program of physical activity will be established after a test done at the local clinical center and based on easy exercises already studied in other diseases (e.g. coronary syndrome or organ transplant). A smartphone application will allow patients to register their daily physical activity and to easily recover data on strength and endurance. Patients in Arm A will have a home-based physical activity prescription and will be supervised at weeks: 4, 6, 8, 10, 12 by the oncologist and an exercise expert of the local sport center through three exercises (body composition test, endurance test and strength test) and questionnaires. Home-based activity will be monitored daily though a specific application (provided by Technogym). Patients in Arm B will receive an exercise counselling without a subsequent supervision. The three tests and questionnaires will be repeated once a month for three months at the local sport center and oncology center. Counselling will include general information on exercise. Patients will undergo blood sampling at baseline, week 4 and week 12 in order to evaluate changes in their immunological state (lymphocyte populations and cytokines).
This is an interventional, non pharmacological, randomized controlled trial evaluating the impact on quality of life of a personalized exercise program in oncogene addicted lung cancer patients undergoing active treatment. At Baseline every patient will receive three tests at the Division of Sport Medicine of Azienda Unità Sanitaria Locale (AUSL) of Romagna (Ravenna) 1. Body composition Analysis: Height, Weight, Bioimpedentiometry (resistance and reactance), Volume of Oxygen (VO2) max. 2. Endurance test: 1 Km treadmill test. 3. Strength test: Repetition of three different exercises (Chest press - upper limbs; Leg press - lower limbs; Lat pull down or Lat Machine or Upper Back). After the three tests have been performed patients will be evaluated for eligibility and randomized into two arms: Arm A (interventional) and Arm B (control). The program will be guided (prescribed and supervised) by an oncologist and a sport medicine doctor. Arm A (interventional): patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application (provided by Technogym). Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions. Arm B (control): patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
patients will have a home-based physical activity prescription, defined on the functional endurance and strength tests and they will be supervised for 3 months. Once monthly they will be examined by the oncologist (visit and questionnaires) and at weeks 4, 6, 8, 10 and 12 at the sport medicine center where the three tests will be repeated. Home-based activity will be monitored daily through a specific application. Endurance improvement is defined as an increase in walking speed; strength improvement is defined as an increase of the number of repetitions
patients will receive a physical activity counselling, without a real prescription and supervision, and the three test will be repeated once a month for three months at the local sport medicine center and at the oncology center (visit and questionnaires). Counselling will include general informations on physical exercise
S.Maria delle Croci Hospital, Oncology Unit
Ravenna, Italy
RECRUITINGImpact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time frame: 12 weeks
Impact of personalized prescription of physical exercises on quality of life assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for lung cancer (QLQ-LC29)
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC29)
Time frame: 12 weeks
Impact of personalized prescription of physical exercises on quality of life assessed by the Beck Depression Inventory II (BDI-II)
To evaluate the impact of a personalized prescription of physical exercises monitored through a special smartphone application on quality of life assessed with the Italian version of Beck Depression Inventory II (BDI-II)
Time frame: 12 weeks
Adherence to prescription
To evaluate the adherence to the step-counter and the strength training prescription monitored through a specific smartphone application. the number of weeks (at least 9 out of 12 weeks) a subject follows the personalized activity prescription will be measured
Time frame: 12 weeks
change of functional capacity
Functional capacity will be measured through the 1 Km treadmill test (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.
Time frame: 12 weeks
change of muscle strength
Muscle strength will be measured through the maximum repetition tests (at baseline; at week 4, week 8 and at week 12): arm A versus arm B. For those in the experimental arm, as the individual progresses with the exercise plan, the exercise dosage will be modulated to facilitate improvements.
Time frame: 12 weeks
tolerance to treatment
Monitoring the frequency, duration, and severity of adverse events (AEs), through physical examinations, changes in vital signs and through clinical laboratory blood.
Time frame: 12 weeks
Overall survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause.
Time frame: 24 months
Patient's satisfaction assessed by dedicated questionnaire
Patient's satisfaction of an App-based system to guide and monitor home-based physical activity is assessed by dedicated questionnaire addressing specific issues
Time frame: 12 weeks
impact of personalized exercise on immunity state
T Lymphocytes modulation during physical activity
Time frame: 12 weeks
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